Identify Patients With Neck Pain Likely to Benefit From Education and Exercise

This study is currently recruiting participants.
Verified by University of Central Florida, June 2010
First Received: June 9, 2010 Last Updated: June 16, 2010

Sponsor:
University of Central Florida
Collaborators:
Nova Southeastern University Franklin Pierce University Florida Hospital
Information provided by:
University of Central Florida
ClinicalTrials.gov Identifier:
NCT01144884

Purpose
The annual incidence of neck pain has been reported to be 14.6%. Other studies outline a wide disparity in the lifetime incidence of neck pain ranging from 22% to 70%. Numerous treatment options exist for the management of neck pain however, there is limited evidence to support which interventions are most effective. Exercise based interventions are commonly used in the treatment of patients with neck pain however; it is not clear which patients are most likely to benefit from this type of treatment. The purpose of this project is to develop a clinical prediction rule (CPR) to identify which patients with neck pain have a greater probability of benefiting from a standardized program of education and exercise. Ninety (90) patients referred to physical therapy will undergo a standardized examination to assess potential predictor variables. Upon completion of the examination a standardized treatment program of education and exercise will be administered regardless of examination findings. Self report measures will be administered on the initial examination and on follow up visits at 2, 4, and 6 weeks. A questionnaire and outcome measures will be also mailed out 6 months after initiation of treatment to assess long-term change. Once the treatment plan is completed, patients will be classified as having either a successful or non-successful response. Subjects which rated their perceived recovery on the Global Rating of Chance (GROC) as "a very great deal better", "a great deal better", "quite a bit better", or "moderately better" (i.e., a score of +4 or greater) will be categorized as having a successful outcome. The primary endpoints to determine the outcome will be analyzed at 6 weeks and 6 months. The result of this study will assist physical therapists to identify sub-groups of patients likely to benefit from a program of education and exercise. The categorization of patients in groups based on beneficial treatments may help to provide improved outcomes.

Condition Intervention
Neck Pain Other: Procedure (education and exercise)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Education and Exercise

Further study details as provided by University of Central Florida:
Primary Outcome Measures:

  • Perceived Disability as measured by the Neck Disability Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Perceived pain intensity as measure by the Numeric pain rating scale [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 6 months ] [ Designated as safety issue: No ]
  • Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Perceived rating of change as measure by the Global Rating of Change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Disability as measured by the Neck Disability Index [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ] [ Designated as safety issue: No ]
  • Perceived pain intensity as measure by the Numeric pain rating scale [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ] [ Designated as safety issue: No ]
  • Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ] [ Designated as safety issue: No ]
  • Perceived rating of change as measure by the Global Rating of Change [ Time Frame: 2 weeks, 4 weeks, 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 90
Study Start Date: August 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
 
Arms Assigned Interventions

 

Single arm trial
Education:To standardize, treatment education will consist of counsel to stay active. Details will be given to subjects verbally & reinforced in the home booklet.

Posture:Facilitation of proper posture has been show to increase recruitment of the lumbar multifidus & deep neck flexors. Instruction will be given verbally & in writing.

Stretching:Stretching exercises will be targeted to address these common impairments. Patients will be introduced to proper stretching procedures. Each stretch will be held for 30s & repeated two times,each side as applicable. The following stretches will be performed:

Upper trap Anterior/medial Scalene Suboccipital Pectoralis

Muscular Performance: Muscle performance will be trained incorporating components of strength, endurance and motor control. Each of the exercises listed below are outlined based on progressions.

Isometric Cervical Extension Craniocervical flexion Seated Row Seated "T" Palms Up Seated Side Arm Raises

Intervention: Other: Procedure (education and exercise)

Other: Procedure (education and exercise) education/exercise Other Name: Procedure (education and exercise)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

  1. Over the age of 18
  2. Primary complaint of neck pain with or without unilateral UE symptoms
  3. Neck Disability Index (NDI) of 10% or greater.

Exclusion Criteria:

  1. Presence of medical "red flags' noted in the Neck Medical Screening Questionnaire. (i.e. tumor, fracture, etc.)
  2. Evidence of central nervous system (CNS) involvement (i.e. hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes such as Hoffman's or Babinski reflexes, etc.)
  3. Spasmodic torticollis
  4. Frequent migraine
  5. Fibromyalgia
  6. Prior Surgery to the neck or thoracic spine
  7. Severe psychiatric illness
  8. Inability to comply with treatment and follow-up schedule
  9. Pending legal action regarding their neck pain
  10. Insufficient English language skills to complete all questionnaires.
  11. Latex allergies
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