Neck Pain Clinical Trial
Official title:
Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
Verified date | February 2009 |
Source | Franklin Pierce University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: The following inclusion criteria will be used to determine eligibility for this study: 1. Primary complaint of neck pain with or without unilateral upper extremity symptoms 2. Age between 18-60 years old 3. NDI score greater than 10 points Exclusion Criteria: The following exclusion criteria will be used to determine ineligibility for this study: 1. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) 2. History of whiplash injury within the past six weeks 3. Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms 4. Evidence of central nervous system involvement, to include 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 (i.e. positive Hoffman's and/or Babinski reflexes), etc. 5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: 6. Muscle weakness involving a major muscle group of the upper extremity 7. Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex) 8. Diminished or absent sensation to pinprick in any upper extremity dermatome |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Concord Hospital | Concord | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Franklin Pierce University | Newton-Wellesley Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neck Disability Index | 4 weeks, 6 months | No | |
Secondary | Pain | 4 week, 6 months | No |
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