Choosing and Using a Low Level Laser in Pain Management
In the last issue of Practical Pain Management, I discussed how the body communicates from cell to cell by generating its own infrared light, called biophotons.1 Biophotons carry information that affects the health and reproduction of cells.2 Low level laser therapy not only promotes healing in injured cells, but it also stimulates the generation of endorphins that control pain regardless of the location.3 Low level laser therapy interrupts the pain process by delivering electrons back to the injured cells to aid in healing.4
One wave length laser cannot efficiently be used for all disorders.5 To maximize the benefits of low level lasers, one needs to employ both resonating and stimulating lasers to maximize the benefits of therapy. When treating musculoskeletal pain, it is best to release the tight muscles related to the bone or joint with a resonating low level laser first then applying the stimulating laser directly to the painful area (joints, nerves, ligaments cartilage and tendons).4
Laser Treatment Strategy
Resonating low level lasers are first applied to soft tissue such as bellies of muscles, organs, and glands because they need less energy and the energy needs to be delivered with a larger beam that spreads out over a larger area.4,6 By contrast, resonating low level lasers produce a smaller dose of energy than stimulating lasers and they usually operate under 5mW. They can be either a single wave length or a multiple wavelength diode laser, but better clinical results seem to be achieved with multi wavelength lasers. If the pain is in an organ or gland, a resonating laser may be all that is needed to control the pain.7
Once the overlying soft tissues have been treated, a stimulating laser—delivering more Joules of concentrated energy at the site—is used on bones, nerves, joints, tendons, cartilage, and ligaments since these tissues require more direct laser energy to control pain. Stimulating low level lasers operate from 5mW to 500mW. However, there are a few brands of lasers that have received FDA 510k pre-market clearance based on comparable heat-producing devices that operate at much higher wattage. While these lasers are sold under the low level laser label, they are not low level lasers and have potentially greater risks for burns and over dosing. Most stimulating lasers available today are single wavelength lasers or multiples of the same wavelengths.
I am not aware of any court cases where the plaintiff charged that she/he was harmed by low level laser therapy however, it is prudent to have the patient sign an informed consent specific for laser treatment. Following is a sample informed consent; however, I strongly recommend that you have your attorney draft an informed consent consistent with the laws of the state where you practice. I like the arbitration statement in the last paragraph and recommend that doctors read that paragraph out loud to the patient. Arbitration does not subjugate the patient’s day in court—it is their day in court. An arbitration agreement removes the risk of costly legal battles, saves time, and reduces stress on the doctor.
INFORMED CONSENT AGREEMENT
I HEREBY accept full and complete responsibility for my health and all conditions thereof related. I acknowledge that neither Dr. ____________, nor any representative thereof, has made promises or treatment claims to me or anyone representing me regarding the use of low level laser therapy.
The undersigned jointly and severally hereby forever release, discharge, acquit, forgive and hold harmless from any and all claims, actions, suits, demands, agreements, and each of them, if more than one, liabilities, judgments, and proceedings both at law and in equity arising from the beginning of time to the date of these presents and as more particularly related to or arriving from the use of a laser device or product, including but not limited __________________(list the brand of your lasers). Releaser understands and acknowledges that these laser devices or products are registered with the FDA; however the FDA has not yet studied these lasers for efficacy for treating ______________(list the disorder) and that neither Dr.____________ nor any individual associated with him nor the company that manufacturers the lasers make any medical claims regarding the use of these devices or products or any low level laser product. This release shall be binding upon and inure to the benefit of the parties, their successors, assigns and personal representatives. It is further agreed that any controversy, dispute or claim between Dr. ___________ or his/her representatives and any other party arising out of/or involving any treatment or care provided by Dr. ___________ shall be resolved by binding arbitration, and shall be submitted to the American Arbitration Association for arbitration which shall be conducted in accordance with the Association’s arbitration rules in effect at the time of applying for arbitration. The arbitral award is final and binding upon both parties. The demand for arbitration must be in writing and must be made by the aggrieved party within ninety (90) days of the event giving rise to the demand.
Signed this __________ day of _________________, 20_____.
In the Presence of: _____________________________________________________
Releaser or Guardian of: _____________________________________________________
How to Choose a Laser System
A suitable low level laser system for your practice should have the following attributes:
- Registered with the FDA for safety
- Possesses state of the art technology
- Is handheld, portable, rechargeable and easy to use
- Multiple wavelengths
- Multiple frequencies
- Ability to penetrate
- Availability of training and of a professional consultant
Registered With The FDA For Safety
If the laser is registered with the FDA, the manufacturer must put the safety classification on the label. (Refer to the laser therapy article describing FDA classification in the May/June 2006 issue.) Pre-market clearance is necessary before any manufacturer or salesperson can make efficacy claims for their instrument to treat a specific disorder. Then those claims are limited to the specific disorder as proven by clinical IRB studies and can not be interpreted to extend to other parts of the body. As an example, if a laser is approved for carpal tunnel syndrome, it cannot be construed that it is approved to treat back pain. Making claims beyond clinical trials is not authorized by the FDA. However in most states, if the device is approved for safety, doctors can use that instrument if they get an informed consent.