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8 Articles in Volume 5, Issue #2
Considerations in Treating Intractable Pain
Hospice Care Evolution
Myofascial Elements of Low Back Pain
Radiofrequency Neuroablation in Chronic Low Back Pain
State Pain Laws: A Case for Intractable Pain Centers Part III
Temporomandibular Joint Referred Pain
The ABC’s of Pain
Therapies for Chronic Pain and Fibromyalgia

Hospice Care Evolution

This personal account of the early days of hospice care provides a perspective on progress to date and lessons learned

The concept of hospice came to the United States from England over thirty years ago as an NCI-funded demonstration project in New Haven Connecticut. In England, the modern hospice movement only began in 1967 with the opening of St, Christropher’s Hospice by Dr. (now Dame) Cicely Saunders in suburban London. Soon thereafter, hospice was considered to be a medical institution in which the physical, social, psychological and spiritual needs of dying persons were addressed in detail. Special emphasis was placed on pain management that was achieved through the use of Brompton Mixture, whose formulation included heroin, an opioid that could not be prescribed in the United States and cocaine, another restricted medication. If hospice were to be emulated in the United States, one would have to find some way to provide excellent pain relief without the utilization of heroin. Part 1 of this two-part series deals with the early development in the United States of approaches to manage the severe, chronic pain often present in persons with advanced, incurable illness.

Early Hospice in the United States

During the early 1970s, there were several approaches to managing this sort of pain:

  • Low dose opioids (morphine 10 mg) on a PRN q 4-6 hour schedule for recurrent pain.
  • Schlesinger’s (oral) solution consisting of low dose morphine, ethyl morphine and scopolamine. The mixture was developed at Johns Hopkins during the early 1900s. Ethyl morphine was more soluble in water than morphine, and hence crossed the blood-brain barrier more rapidly than morphine. Scopolamine is a ‘dissociative’ analgesic that was also used in the early part of the last century in obstetric analgesia in a combination known as “twilight sleep.”
  • Polypharmacy was a common approach. Typically each patient received:
    —sub-analgesic doses of meperidine on a PRN schedule
    —a phenothiazine tranquilizer
    —a barbiturate for nighttime sedation
    —a steroid to stimulate appetite and combat weight loss
    —an anti-depressant “because she must be depressed”
  • Pain was left untreated. All sorts of rationalizations supported this approach, ranging from pain as a way to atone for sins, pain as a necessary element of disease, and pain as evidence of moral weakness.

Several brief examples from my early experience will convey the sort of situations faced in the early days of hospice care (early 1970’s):

  1. A long-time family practitioner asked me to see a patient in a local hospital. During the referral call he referred to this woman as “the most difficult problem in my fifty years of practice.” After climbing stairs to the third floor of the hospital, I opened the fire door and could hear the patient crying out in pain. I stopped at the nurse’s station to check the chart and saw that I was the seventeenth doctor called in consultation. Each one had left a note recommending something different. I also saw that the lady was receiving a combination of drugs to treat each of her individual symptoms: pain (meperidine), anxiety (phenothiazine), depression (anti-depressant), insomnia (barbiturate), and anorexia (steroid). The lady was so sedated that she was incoherent. She was in considerable pain, moaning and crying out. She could not tolerate being touched.
  2. A doctor referred a hospitalized young man for hospice home care. Two of the nurses with whom I worked went to the hospital to gain some background information to prepare the patient for transfer to home. While they were there, the doctor appeared. The patient pleaded with his doctor to provide enough medicine to relieve his pain. The doctor looked down at the bedridden patient and said, “The reason you are having so much pain is that the devil is in your body.”
  3. A doctor referred a middle aged man with metastatic prostate cancer for hospice care after the man said to him, “Doctor…if you can’t keep me comfortable in the hospital, then why can’t I suffer at home?”
  4. A friend called me and asked how referrals were made to hospice. I explained the procedure and then asked for the name of the patient. He replied, “It’s me, Bill.” He had recently visited the two leading pain clinics in our part of the country where he was told, “You have intractable pain.” Both programs sent him home with large bottles of meperidine for injection. It was of little benefit to him. When I visited him at home that day he asked, “If you can’t relieve my pain, will you please get something to kill me.”

The above case examples were not at all unusual in those days. There were very few pain clinics in the entire country. Very little was being written about pain management. Few doctors were adequately trained to understand — much less treat — severe, chronic pain. Many doctors attempted pain control. When their efforts failed, it was not uncommon to hear the phrase “intractable (untreatable) pain” or the rationalization that the patient had developed “tolerance to normal doses” and “was becoming addicted.”

Inadequate Medical Education in Pain

Medical and other health professional school courses on pain were generally inadequate in the early days and may still be somewhat inadequate today. Clinical training passed inadequate practices, fears and prejudices from one generation to another. Doctors inherited, unquestioningly, the mistaken assumptions of their mentors. When dealing with patients in pain, doctors feared abetting the development of addicts, facing the possibility of overdose, or dealing with the probability of having to withdraw an addicted or dependent patient. Doctors further shied away from using narcotics because they had been warned of the high addiction rate among medical personnel.

My early experience with opioids was different. While studying pharmacology in medical school, I investigated the structure and functional relationships of the morphine group of drugs. During training in psychiatry I had the opportunity to observe withdrawal of addicts at the Federal Narcotics Hospital in Lexington, Kentucky. During my early years of practice I worked in drug abuse programs in San Francisco. I joined with Dr. Fred Myers of the Department of Pharmacology at the University of California, San Francisco, in doing research into the narcotic withdrawal process. We conducted a research program, for example, in the use of ganglionic blocking agents to modify the physiological response to opioid withdrawal. Later, as I became more involved in working with persons who were dying, I found that my experience with persons addicted to opioids was invaluable in my later work of pain management in persons with end-stage cancer.

One of the important lessons I learned during these years before I became interested in work with dying persons was that not everything I had been taught in medical school and my clinical years was necessarily true. I learned to question assumptions about the way the medical establishment dealt with severe, chronic pain. I questioned the need for heroin to provide good pain relief. I could see the side effects of repeated high doses of meperidine reduced its favor as the drug of choice for severe, chronic pain. I saw that the fear of addiction, overdose and withdrawal were exaggerated when morphine was used in adequate doses and at proper intervals to treat severe pain.

I also learned another important fact about opioid dosing for patients with severe, chronic pain. It was commonly held that once you began to prescribe opioids for patients with severe, chronic pain secondary to advanced cancer, that the dose would have to be continually increased. Because we asked our patients to maintain careful, continuous records that showed both their 4 hourly dosing of oral morphine plus their level of comfort/discomfort on a scale of 0-10, we learned that once pain was satisfactorily controlled on a 24 hour basis over several days, that it was usually possible for the dose of opioid to be gradually reduced without recurrence of pain.

Comfort Control

A simple visual analog scale was used to allow the patient to measure their discomfort level daily. We called the graphic the “Comfort Control Chart” (CCC). Time was demarcated on the abscissa; intensity of pain on the ordinate, with zero indicating freedom from pain and ten indicating the greatest intensity of pain. Time was most commonly divided into 4 hour segments so that the patient would be reminded to indicate relief of pain or lack of relief at the time of taking the next dose of opioid. To obviate middle of the night awakening, we learned to order double the usual dose at bedtime so that the middle of the night dose could be skipped.

Sleep is a vital consideration for patients experiencing severe, chronic pain. We observed that patients whose pain was at level “five” or above generally had difficulty going to sleep or remaining asleep. Those who recorded a level of “four” or lower were generally able to sleep through the night.

We also found it important to reduce injection of opioids, as many people objected to the discomfort of repeated injections. We learned from repeated observation that if the dose of opioid was adequate, it was feasible to schedule doses of immediate release morphine (MSIR) every four hours. MSIR prescribed “every 4-6 hours PRN (as needed) for pain” most often was inadequate to control pain on a continuing basis. We knew from our observations that the half-life of a single dose of MSIR was about two and one-half hours. Less than optimal levels of MSIR every four hours or every 4-6 hours, prn, resulted in recurrence of pain between doses. The proper (optimal) dose of MSIR every four hours provided ongoing pain relief without intervals of recurrent pain.

As we gained experience in managing severe, chronic pain, it became clear that untreated, chronic pain never occurred alone. It was accompanied by symptoms of anxiety, depression, insomnia, anorexia, frustration, isolation and eventually… thoughts of suicide. It was also accompanied by memories of past pain plus anticipation of pain yet to come. Prior to learning to use adequate 4 hourly doses of MSIR and the Comfort Control Chart, it was common to use polypharmacy to treat each of the above symptoms. Pain was generally under-treated; anxiolytics were prescribed to reduce anxiety, anti-depressants were prescribed to treat the depression of patients in pain, barbiturates or phenothiazines were prescribed to manage the insomnia, steroids were offered to increase appetite as well as to counter weight loss.

We suspected that once pain was brought under good control and patients were able to sleep, that their confidence about relief of pain in the future was restored. With adequate sleep and hydration, they were more likely to eat than they had done while experiencing chronic or recurrent severe pain. If depression had been present, it usually cleared more rapidly with pain relief than was usually the case during anti-depressant therapy.

Cautions and Side-Effects

It is important to keep in mind that there are several side-effects to the continuing use of morphine and other opioids. The first is respiratory depression. Opioids do slow the respiratory rate. Large doses given to persons who have not been taking opioids can result in a noticeable slowing of the respiratory rate. Tolerance to respiratory slowing develops rather rapidly so that it is possible to escalate doses gradually during the first several days of administration. The color of the nail beds and the depth of respiration (tidal volume) are as important — if not more important — than the respiratory rate when assessing respiratory depression. A person in great pain may breathe both rapidly and superficially (shallow breaths) but after pain relief from a dose of MSIR may breathe less frequently but have a larger tidal interchange. Pink coloration of unvarnished nail beds is a good sign. At no time in over thirty years of hospice work have I personally seen an indication for the administration of narcotic antagonists. This includes cases of the unintended intravenous administration of large doses of morphine to patients who were currently receiving 4 hourly lower doses of MSIR. Respiratory depression is therefore an “initiation” (beginning) side-effect of opioid administration.

Constipation is a serious side-effect of opioid administration that must be treated all the while a person receives opioids. Stool softeners alone are not sufficient to prevent constipation. An active laxative especially of the senna group of preparations is needed to initiate and maintain colonic motility. As Dame Cicely Saunders stated repeatedly, care of the bowels is essential to hospice care. Proper diet and adequate fluid intake are part of a good bowel regimen. Failure to provide laxation or to attend to bowel care is one of the major areas of concern when providing pain relief to persons with advanced illness.

The third side-effect to consider is nausea and vomiting. MSIR and other opioids stimulate the nausea and vomiting center in the medulla. Like respiratory depression, this is an initiation side-effect and a perfectly normal response. Patients who are told that this side-effect might occur are not surprised if it happens, whereas those who are not informed are prone to wonder about what is going wrong. Anti-emetic medications are usually helpful in relieving or modifying these symptoms. The aroma of certain foods, especially fried foods, may contribute to nausea. A number of other non-opioid medications also cause nausea and vomiting. It is reassuring to patients to learn that nausea and vomiting are common, normal and usually transient.

The fourth side effect to consider is allergy. Many people have been told that they are “allergic” to morphine because they developed a red line or wheal or flare upon receiving IV or sub-cutaneous doses of an opioid. The allergic response is probably not due to the morphine molecule itself but to plant proteins remaining from incomplete filtration during the refining of morphine. Should allergic symptoms persist, transfer to another opioid preparation like methadone or Dilaudid® would provide an alternative with less likelihood of allergic response.

“...once pain was brought under good control and patients were able to sleep...their confidence about relief of pain in the future was restored. With adequate sleep and hydration, they were more likely to eat than they had done while experiencing chronic or recurrent severe pain. If depression had been present, it usually cleared more rapidly with pain relief than was usually the case during anti-depressant therapy.”

Lessons Learned

We learned several important lessons about pain management in the early days of hospice.

  • What we had been taught about the use of opioids to manage pain was not necessarily true.
  • Doctors who had not experienced pain themselves were less likely to be interested in providing excellent pain relief than those who had experienced pain.
  • We learned about the paradox of treating chronic pain. Once pain relief is obtained, the dose of analgesic can be gradually reduced without recurrent pain. This finding is contrary to the assumption of most doctors and patients.
  • It is easier to manage pain in home care hospice patients than in the hospital.
  • Pain is what the patient says it is. Margo McCaffrey, RN, popularized this maxim. We learned to ask patients to keep records of their comfort/discomfort.
  • Untreated severe, chronic pain tends to increase in severity. Therefore it is wise to develop pain control early rather than wait until it escalates into a multi-symptom phenomenon.
  • At end of life, less opioid analgesic is required due to slowed metabolism and excretion.
  • There are lessons to be learned from persons addicted to opioids. Chief among them is the fact that — once tolerance develops to respiratory depression — persons taking very large amounts of opioid analgesics are capable of performing complicated procedures, like driving cars and going back to work. We do not recommend doing this, but the observation is of value when doctors balk at giving more than homeopathic doses of opioids to patients in pain.
  •  
  • Outdated patient and family attitudes toward opioid analgesics can interfere with the production of effective analgesia. Mistaken assumptions, needless fears, and belief in the value of suffering can interfere with the relief of pain. Pain is not an inevitable part of dying. There is no spiritual or psychological benefit to suffering. Negative family attitudes toward pain relief need to be uncovered, challenged and corrected.
  • • Persons with advanced illness usually have multiple sources of pain. Ask patients to indicate the sources of their pain on a graphic chart. Ask them to rate the intensity and timing of the pain. This is an invaluable part of a plan to relieve pain.
  • • Morphine and other opioids are not the answer for every type of pain. Some pains are relieved by other types of analgesics.
  • • PCA pumps are very rarely indicated in the management of severe, chronic pain. Carefully monitored oral opioids are usually sufficient. PCA pumps may be beneficial in certain situations, but may require technical support, add what may be unnecessary cost and add another level of unnecessary complexity. The availability of extended duration oral opioid analgesics, as well as transdermal opioid patches, have also reduced the use of PCA pumps. The availability of oral fentanyl ‘suckers’ for management of breakthrough pain further reduce the indication for PCA pumps.

Hospice Pioneer

Dr. Lamers completed residency training in psychiatry at The Cincinnati General Hospital and a fellowship in Child Psychiatry at The Child Guidance Home. After a tour of active duty with the United States Navy Medical Corps during the early 1960’s he entered private practice in Marin County, California, in 1965. While practicing psychiatry in Marin County, Dr. Lamers was a member of the clinical faculty (Associate Clinical Professor) of the University of California in San Francisco. He founded a school for autistic and neurologically impaired children, developed a community drug abuse program and was principal investigator in pharmaceutical research projects involving the lithium ion in the treatment of depression as well as the use of ganglionic blocking agents in the management of narcotic withdrawal.

In the early 1970s, Dr. Lamers established one of the earliest hospice programs in the United States, Hospice of Marin. As an outgrowth of this work he helped establish the first training program for persons interested in hospice development. For several years he also served as chairperson of the Standards and Accreditation Committee of the National Hospice Organization.

Dr. Lamers is a long-time member of the International Work Group on Dying, Death and Bereavement and served as president of the board of directors in 1983 and 1984. In 1981 Dr. Lamers accepted dual appointments as Associate Clinical Professor on the faculties of the University of Calgary Medical School and the Tom Baker Cancer Centre in Calgary, Alberta, where he was involved in hospice development and the training of physicians. In 1985 he was involved in the development of the Chris Brownlie AIDS Hospice in Los Angeles. From 1991 to mid-1995 he was Medical Director of Hospice of the Canyon, and from 1995 to 1996 Medical Director of Avalon Hospice. He is a member of the Southern California Cancer Pain Initiative and serves on its Regulatory Control Committee.

Dr. Lamers has written and co-authored a number of books and papers on a variety of subjects in the fields of medicine, psychiatry and hospice care. He has lectured widely in the United States and in many foreign countries. He has received numerous awards in recognition of his pioneering work in the development of hospice care in the US. Dr. Lamers is now based in Malibu, California, and works as a consultant in the areas of hospice, palliative care and pain management and is currently the medical consultant to the Hospice Foundation of America.

Summary

The management of severe, chronic pain associated with end-stage disease has changed considerably over the past thirty years. Brompton Mix and heroin, once considered essential to the management of cancer pain, are no longer used. New medications and techniques have made it easier to provide ongoing 24x7 relief of pain. There is still a wide gap between what we know about pain management and the general clinical application of that knowledge. Mistaken assumptions about pain and the treatment of pain still dominate large areas of modern health care. The introduction of hospice has had a positive influence on pain relief in a number of countries. For the first time in the United States, legal decisions and bio-ethical determinations have begun to emphasize the fundamental right of patients to relief from severe, chronic pain.

One of our objectives in the early days of hospice was to teach new pain management techniques to doctors who referred patients to hospice. This meant that we did not “take over” prescribing of pain medications nor did we assume overall medical responsibility for patient care. This was not done to shun responsibility. It was done to encourage the development of communication between the hospice staff and the attending physician so that we could learn from one another for the ultimate benefit of all patients. The earlier English model of hospice entailed use of an inpatient facility in which the hospice doctor assumed total responsibility for patient care. The American model of hospice was based on care provided in the patient’s home by an interdisciplinary team that included both the hospice doctor and the attending physician. n

Acknowledgements

In addition to valuable feedback from countless hospice patients, the author wishes to acknowledge the encouragement, support and availability of Arthur Lipman, PharmD, Deanna Dimmit, PharmD, Frederick Myers, MD, PhD, as well as the Staff of Hospice of Marin.

Interestingly enough, primary care physicians frequently see patients in their offices with complaints of wrist pain. The causes of wrist pain are typically related to overuse, as well as repetitive and high impact injuries that may be work or sports related. These injuries often start as an acute tendonitis or ligament sprain and, if not effectively treated, can result in chronic pain due to the formation of degenerative arthritis. Symptoms are frequently gradual at first - with mild aching but full range of motion - and then typically progress to more acute pain along with impaired movement of the hand and upper extremity. Approximately one person in seven (13.6%) of the U.S. population has degenerative wrist arthritis.1

Typical treatments for unresolved wrist pain, including degenerative arthritis, are conservative in nature. These treatments include rest, physical therapy, NSAIDs, splinting, cortisone injections, and ergonomic modification of work stations. Though these treatments are commonly prescribed, they often produce only temporary results. Objective proof to support the use of these treatments is lacking.2,3 When the pain does not remit - especially pain related to carpal instability - the patient is then often referred to a surgeon to assess for surgery. Surgery is usually arthroscopy or a fusion.4 As surgery can be fraught with complications - such as plate tenderness, nonunion, distal radioulnar joint pain or dysfunction, persistent unexplained pain, and carpal tunnel syndrome - patients often look for other options.5 However, because traditional wrist pain therapies often do not result in positive remission of symptoms, many patients are turning to alternative therapies such as prolotherapy to achieve positive outcomes.6

Prolotherapy, an injection therapy that stimulates the body to repair weak/injured areas of the body, is fast developing into a recognized form of pain management in both the complimentary and allopathic medicine fields. Its primary use has been related to the pain management associated with tendinopathies and ligament sprains in peripheral joints.7,8 Prolotherapy is also effectively used in the treatment of spine and joint degenerative arthritis.9,10 In double blind human studies, the evidence to support the effectiveness of prolotherapy has been considered encouraging but varied.11-14

George S. Hackett, MD coined the term prolotherapy and was one of the originating prolotherapy pioneers back in the 1940s. Hackett wrote, "The treatment consists of the injection of a solution within the relaxed ligament and tendon which will stimulate the production of new fibrous tissue and bone cells that will strengthen the 'weld' of fibrous tissue and bone to stabilize the articulation and permanently eliminate the disability."15

Animal studies have shown that prolotherapy stimulates the production of new collagen by initiating the normal inflammatory reaction.16,17 Animal studies have also revealed ligament and tendon diameter and strength improvements with prolotherapy.18-20 While prolotherapy is commonly taught and used for unresolved wrist pain,21 no study has been done to date related to effectiveness. This observational study's purpose was to evaluate the effectiveness of Hackett-Hemwall dextrose prolotherapy - not only on unresolved wrist pain but on quality of life measures, and its ability to reduce or eliminate the need for pain medications.

PATIENTS AND METHODS

Framework and Setting

In October 1994, the primary authors of this study opened a Christian charity clinic called Beulah Land Natural Medicine Clinic located in an impoverished area of rural southern Illinois. An all volunteer staff composed of MDs, RNs, clinical assistants, and administrative staff ran the clinic every three months until July, 2005. Hackett-Hemwall dextrose prolotherapy was utilized as the treatment of choice. Dextrose was selected because it is the most common proliferant used in prolotherapy. The patients traveled from many different areas of the country to receive prolotherapy - primarily from Kentucky, Missouri, and Illinois. The patients were seen and treated free of charge.

Patients

Patients who received prolotherapy for their unresolved wrist pain in the years 2000 to 2005 were called by telephone and interviewed by an independent data collector (D.P.) who had no prior prolotherapy knowledge. General inclusion criteria were the following: at least 18 years of age, presence of an unresolved wrist pain condition that typically responds to prolotherapy, and a willingness to undergo at least four prolotherapy sessions, unless the pain remitted with fewer prolotherapy sessions. Typical wrist conditions that responded to prolotherapy included carpal instability, tendinopathy, ligament sprain, and wrist degenerative arthritis. Patients who were thought to have median nerve entrapment were not included.

Interventions

The 31 wrist pain patients each received prolotherapy for their painful condition using the Hackett-Hemwall technique of prolotherapy. Each patient received 20 to 30 injections of a 15% dextrose, 0.2% lidocaine solution with a total of 15 to 30cc of solution used per wrist. Injections were given into and around the painful and/or tender-to-touch areas of the wrist. Figure 1 outlines the typical injection sites where 0.5 to 1cc of solution were given. Tender areas injected included the carpal bones, as well as ligament and tendon attachments in the wrist. The patients were asked to reduce or eliminate pain medications as much as the pain would allow.

Outcomes

Only one person (D.P.) conducted the telephone interviews and obtained patient data. The patients were asked a series of questions related to pain and various symptoms before starting prolotherapy. Their response to prolotherapy was also detailed with an emphasis on the effect prolotherapy had on their wrist pain, stiffness, and quality of life. Data collection consisted of questions concerning years of pain, pain intensity, stiffness, number of physicians seen, medications taken, quality of life concerns, psychological factors and whether the response to prolotherapy continued after the prolotherapy sessions ended.

Statistical Analysis

An independent data analyst (D.G.) tabulated, graphed, and presented the results of the data collected by D.P. during the telephone interviews. The responses gathered from patients before prolotherapy were compared with the responses to the same questions after prolotherapy. Results were also calculated for two subgroups of patients who were either told that no other treatments were available in the opinion of the patients’ physicians or who were told prior to starting prolotherapy that surgery was their only option for their wrist pain. A matched sample paired t-test was used to determine statistically significant improvements in the before-and-after prolotherapy measurements for pain, stiffness, and exercise ability in all wrists, as well as the two subgroups described above.

Patient Characteristics

Complete data was obtained on a total of thirty-one wrist pain patients who met the inclusion criteria. Eighteen (63%) were female and thirteen (37%) were male, with an average patient age of 55 years. Patients reported an average wrist pain duration of four years and four months and the average patient saw 2.6 MDs before receiving prolotherapy. The average patient was taking 1.1 pain medications prior to receiving prolotherapy. Fourteen (45%) were told by their physicians that no other treatment options for their chronic wrist pain existed. Five (16%) stated that the only other treatment option given for their wrist pain was surgery. A summary of the patient demographics is presented in Table 1.

Table 1. Patient Characteristics Prior to Prolotherapy
Wrist patients 31
Percentage of female patients 63%
Percentage of male patients 37%
Average age of wrist patients 55
Average years of pain 4.3
Average number of MDs seen 2.6
Average number of pharmaceutical drugs 1.1
No other treatment options available 45%
Surgery only other treatment option 16%

Treatment Outcomes

Patients received an average of 3.6 prolotherapy treatments per wrist. The average time of follow-up after their last prolotherapy session was twenty-two months.

Patients were asked to rate their pain and stiffness levels on a scale of 1 to 10 with 1 being no pain/stiffness and 10 being severe crippling pain/stiffness. Starting pain level averaged 5.5 and stiffness 3.7. Ending pain and stiffness levels were both 1.4 after prolotherapy. Seventy-four percent exhibited a starting pain level of 5 or greater, while only 13% had a starting pain level of two or less; whereas after prolotherapy zero reported a pain level of 5 or greater, while 90% had achieved a pain level of two or less (see Figure 2).

Ninety-seven percent of patients reported improvement in pain, with 88% showing improvement in stiffness after prolotherapy. Over 90% reported that pain and stiffness improvements have been sustained 100% since their last prolotherapy treatment. Ninety percent of patients stated prolotherapy relieved them of at least 50% of their pain. Sixty-one percent received greater than 75% pain relief. Ninety-seven percent of patients achieved at least 25% pain relief with prolotherapy. In regard to pain medication usage, before prolotherapy the average patient was taking 1.1 pain medications, but this decreased to 0.2 medications after prolotherapy. Prior to prolotherapy 17 (55%) of the patients were taking one or more medications, but at follow-up, 22 months after their last prolotherapy session, only 7 (23%) patients were taking one pain medication. 100% of patients who were not taking pain medications at the time their prolotherapy sessions ended never returned to needing pain medications.

Eighteen patients (58%) reported wrists with incomplete range of motion before prolotherapy. After prolotherapy, only six (19%) patients reported incomplete range of motion in their wrists (see Figure 3). Patients average wrist crepitation was 2.8 before prolotherapy, but only 1.5 after prolotherapy.

In regard to quality of life issues prior to receiving prolotherapy, 80% were totally independent in activities of daily living, but this increased to 94% after prolotherapy. In regard to exercise ability before prolotherapy, only 36% could exercise greater than 30 minutes, but after prolotherapy this increased to 87 % (see Figure 4).

Feelings of depression were reported in 32% and feelings of anxiety were reported in 38% of the patients prior to prolotherapy treatment. After prolotherapy, feelings of depression were reported in 10% and feelings of anxiety were reported in 16% of the patients (see Figures 5 and 6). Interrupted sleep due to wrist pain was reported by 55% of the patients prior to prolotherapy treatment while improvement in sleep was reported by 82% of the patients after prolotherapy treatment.

To a simple yes or no question, “Has prolotherapy changed your life for the better?” All of the patients treated answered “yes.” Seventy-seven percent of the patients reported that, overall, greater than 75% of their improvements resulting from prolotherapy remained positive after prolotherapy treatments ended. Of those whose pain/disability had increased since stopping the prolotherapy, 81% noted reasons for this occurrence. Fifty-five percent claimed the prolotherapy was stopped too soon (before 100% pain relief was achieved). Twenty-two percent reported a re-injury to the area. One hundred percent of patients knew someone who had received prolotherapy. Sixty-eight percent came to receive their first prolotherapy session on the recommendation of a friend. One hundred percent of patients have recommended prolotherapy to someone.

Results for those told no other treatment options were available or surgery was their only treatment option

As previously noted, prior to prolotherapy 14 (45%) patients were told no other treatment options were available for their wrist pain. As a group they suffered with pain an average of 66 months. Analysis of these patients revealed a starting average pain level of 6.2 and a post-prolotherapy pain level of 1.5. Wrist stiffness averaged 4.0 prior to prolotherapy treatments and improved to 1.5 after completing the treatments. Eleven out of fourteen (78%) achieved 50% or greater pain relief. Prior to prolotherapy only 36% of the patients could exercise longer than 30 minutes, but this increased to 78% after prolotherapy.

Five patients (16%) were told that surgery was the only option available to eliminate their wrist pain. Their average pain duration prior to prolotherapy was 39 months. Their starting average pain level was 4.8 before prolotherapy, which declined to 1.2 after prolotherapy. Reported wrist stiffness was 1.8 prior to prolotherapy and 1.0 after completing their prolotherapy treatments. All five patients (100%) exhibited 50% or greater pain relief. One out of five of the patients could exercise longer than 30 minutes prior to prolotherapy, but this number increased to four out of five after prolotherapy (see Table 2).

Statistical Analysis

A matched sample paired t-test was used to calculate the difference in responses between the before and after measures for pain, stiffness, and exercise ability for the 31 patients—including the subgroup of 14 patients who were told by their medical doctor(s) that no other treatment options were available, and the subgroup of five patients who were told by their medical doctor(s) that surgery was their only option. Using a paired sample t-test, all p values for pain in all three groups reached statistical significance at the p

Demographics All Wrist Patients No Other Treatment Options Surgery Only Option Given
Total number of patients 31 14 5
Average months of pain 52 66 39
Average pain level before prolotherapy 5.5 6.2 4.8
Average pain level after prolotherapy 1.4 1.5 1.2
Paired t ratio 13.463 9.099 4.811
P value 0.000000 0.000001 0.008579
Table 2. Summary of results for retrospective study of patients with wrist pain treated with destrose prolotherapy.

DISCUSSION

Principle Findings

Hackett-Hemwall dextrose prolotherapy treatments have produced statistically significant improvements in wrist pain, stiffness, and quality of life measurements in this unique patient population as concluded from this retrospective, uncontrolled, observational study. More specifically, Hackett-Hemwall dextrose prolotherapy for chronic wrist pain resulted in 61% of patients achieving greater than 75% pain relief; with 90% achieving 50% or more pain relief. Pain and quality of life improvements were reported in 100% of the patients after receiving prolotherapy for their wrist pain. Substantial improvements in other quality of life areas including stiffness, range of motion, depression, anxiety, sleep, exercise ability, and medication usage was also reported in this prolotherapy study.

Data analysis for the nineteen patients (61%) in the “no other treatment options available” subgroup or the “surgery was their only option” subgroups showed notable improvements in pain, stiffness, and exercise ability with Hackett-Hemwall dextrose prolotherapy.

Study Strengths and Weaknesses

This study admittedly does not compare to a clinical trial under controlled conditions. As a retrospective study, we are examining the response of patients with unresolved wrist pain to the Hackett-Hemwall technique of dextrose prolotherapy at a volunteer medical clinic. Noticeable strengths of the study relate to the number of parameters studied which are vital to helping patients with wrist pain again achieve the ability to function in their daily lives. Parameters such as range of motion, stiffness, athletic (exercise) ability, sleep, anxiety, depression, use of pain medication, in addition to pain level, are important factors affecting the person with unresolved wrist pain. The improvement in such a large number of variables treated solely by prolotherapy is likely to have resulted from the prolotherapy, rather than by chance. So while there is no medical test to document pain improvement or the progress with prolotherapy, an increased ability to exercise, sleep, and use less medications are objective changes that are noted.

Nineteen patients (61%) were either told by their MDs that no other treatment option for their pain was available or that surgery was their only option. Clearly this patient population represented chronic unresponsive pain. An average follow-up period of twenty-two months since their last prolotherapy session, along with the fact that 100% of the patients reported lasting improvements in their wrist pain, indicated that the changes were due to the prolotherapy treatments.

Because this was a volunteer free medical clinic with limited resources and personnel, the only therapy that was used was prolotherapy. The prolotherapy treatments could only be given every three months. In private practice, the Hackett-Hemwall technique of dextrose prolotherapy is typically given every four to six weeks. In a patient who is not progressing as desired and/or who has poor healing ability, the prolotherapy solutions may be changed and strengthened. The patient may also be advised on additional measures to improve their overall health and may include advice on diet, supplements, exercise, weight loss, changes in medications, additional blood tests, and/or other medical care. Private patients are immediately weaned off anti-inflammatory and narcotic medications that inhibit the inflammatory response needed to produce a healing effect from prolotherapy. Since this was not done at this clinic, the results of this study are an indication of the minimum level of success with Hackett-Hemwall dextrose prolotherapy. This makes the results even that much more impressive.

A shortcoming of our study is the subjective nature of some of the evaluated parameters. Subjective parameters of this sort included pain, stiffness, anxiety, and depression levels. The results relied on the answers to questions by the patients. X-ray and MRI correlation for diagnosis and response to treatment was also lacking. Limited physical examination documentation in the patients’ charts made categorization of the patients into various diagnostic categories impossible.

Interpretation of Findings

Hackett-Hemwall dextrose prolotherapy was shown to be very effective in eliminating pain, stiffness and improving the quality of life in this group of patients with unresolved wrist pain. This included the subgroup of patients told that no other treatment options were available or that surgery was their only option. Current conventional therapies for unresolved wrist pain include medical treatment with analgesics, non-steroidal anti-inflammatory drugs, anti-depressant medications, steroid injections, trigger point injections, muscle strengthening exercises, bracing, physiotherapy, rest, massage therapy, manipulation, acupuncture, education, and counseling. The results of such therapies are typically short term and often leave the patients with unresolved pain. When these treatments fail, the surgical procedure most often recommended for those with chronic unresponsive wrist pain is wrist arthrodesis.22 Wrist arthropathy occurs most often in the scapholunate joint from resultant scapholunate ligament injury and resultant instability.23 A common finding associated with the development of wrist arthropathy is carpus instability or laxity of the intercarpal ligaments. Typically trauma to the carpal ligaments results in abnormal joint reaction forces with each movement of the wrist. The process produces degeneration of the articular cartilage, resulting in radiocarpal arthritis, selective intercarpal arthritis, or pancarpal arthritis, depending on the initial injury and subsequent healing. Wrist degenerative arthritis is nearly identical to arthropathy in other joints, including the hip and knee. The principle problem is loss of articular cartilage between the carpal bones and/or the metacarpal and distal radius. Surgery is indicated for wrist arthritis when disabling pain emerges despite non-operative treatment.

While wrist arthrodesis can result in a high degree of patient satisfaction, limitations of wrist motion are a certainty.24 With access to medical information on the Internet, people with chronic wrist pain are searching for alternatives to surgery and traditional therapies that have not proven to be effective. One of the treatments that chronic wrist pain patients are learning about and trying instead of surgery is prolotherapy.25,26

Prolotherapy is the injection of a solution for the purpose of tightening and strengthening weak tendons, ligaments, or joint capsules. Prolotherapy works by stimulating the body to repair these soft tissue structures. It starts and accelerates the inflammatory healing cascade by which fibroblasts proliferate. Fibroblasts are the cells through which collagen is made and by which ligaments and tendons repair. Prolotherapy has been shown in one double-blinded animal study in a six-week period to increase ligament mass by 44 percent, ligament thickness by 27 percent and the ligament-bone junction strength by 28 percent.27 In human studies on prolotherapy, biopsies performed after the completion of prolotherapy showed statistically significant increases in tendon and ligament collagen fiber and diameter of 60 percent.28,29

One explanation for the lack of response of chronic wrist pain sufferers to traditional conservative therapies is that their underlying problem, ligament laxity, is not being addressed. Ligaments are notorious for not healing.30,31 Ligament injury has been implicated as one of the major causes of degenerative osteoarthritis in joints, not just the wrist.32-36 Typically in the early stages of wrist arthritis, the problems are mainly caused by carpal instability from ligament injury.37,38 Prolotherapy has been shown to decrease pain by stimulating tissue repair in degenerated tissues such as ligaments and tendons.39-43

Traditional surgical treatments aim to rectify the anatomic position and to correct the carpal instability to prevent degeneration of the wrist. Presumably, the same occurs with prolotherapy to the wrist. The goal of the prolotherapy treatment is to eliminate pain and prevent further degeneration by stimulating the injured ligament(s) to heal. If the arthritic process has progressed, prolotherapy helps to stabilize the unstable joints. Unlike wrist fusion, however, prolotherapy for chronic wrist pain, as indicated in this study, helps improve range of motion, not diminish it. Because this subgroup study population of only five patients that looked to prolotherapy as an alternative to a surgery had great results with prolotherapy, further research is warranted into using prolotherapy as an option to wrist surgeries such as arthrodesis.

Conclusions

Thirty-one patients with an average pain duration of 52 months, were treated quarterly with Hackett-Hemwall dextrose prolotherapy in a free medical clinic. Included in this group were nineteen patients (61%) who were told by their medical doctor(s) that no other treatment options for their pain were available or that surgery was their only option. Patients were contacted an average of 22 months following their final prolotherapy session and asked questions via telephone interview regarding levels of pain, stiffness, other physical and psychological symptoms, as well as questions related to activities of daily living, before and after their last prolotherapy treatment.

 

Improvements in many quality of life parameters were achieved in this patient population who received the Hackett-Hemwall dextrose prolotherapy for their wrist pain. This patient population experienced wrist pain for an average of four years and four months prior to receiving treatment. Upon interview at twenty-two months, on average, after their last prolotherapy sessions, this study revealed improvement in patients’ quality of life parameters such as pain, stiffness, depression and anxiety, medication usage, as well as range of motion, sleep, and exercise ability. This included patients who were told no other treatment options existed or that surgery was their only option for their unresolved wrist pain. Ninety percent of patients had 50% or more pain relief and 88% felt improvement in their stiffness levels. All patients who were taking pain medications prior to receiving prolotherapy were able to reduce the frequency of required medications after receiving prolotherapy.

Since this pilot study found such significant improvements in these participants with chronic unresolved wrist pain, further studies under more controlled circumstances and with larger patient populations should be done. n

Last updated on: April 28, 2016
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