Chronic Mechanical Neck Pain Clinical Trial
Official title:
Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
Eligible subjects with chronic neck pain will be randomly allocated to one of two
intervention groups: real vs control spinal manipulation. They will receive three
intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in
one week by random assignment to treatment group with either of the dual delivery procedures
(Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error
rate of self-report of group allocation at exit interview.
H2: Patients treated by the typical-control dual procedure over a typical sequence of
encounters (3 times in one week) will show statistically significant improvement in clinical
outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index
(NDI), range of motion and pressure algometry; compared to those treated by the
control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no
significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
Status | Completed |
Enrollment | 319 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male or Female - 21 to 60 years of age - Chronic neck pain - Neck pain duration greater than 6 weeks - Numeric Rating Scale greater than 30, less than 65 - Pain distribution between nuchal ridge and spine of the scapula - Pain aggravated by local provocation maneuvers at single motion segment - Antero-posterior glide - Paraspinal tenderness - Negative provocative maneuvers at adjacent segment - Able to tolerate neck movement to 50 percent normal in all directions Exclusion Criteria: - Worker's compensation or other medico-legal claim - Cervical spine surgery or fracture or dislocation - Uncontrolled hypertension (Blood Pressure over 140 over 90) - Stroke or Transient Ischemic Attack - Upper respiratory infection within 4 weeks - Severe degenerative disease of the cervical spine - New or significantly altered pattern of headache complaint - Connective tissue disease - Primary fibromyalgia - Metabolic or metaplastic bone disease - Whiplash injury within 12 months - High cholesterol levels not well-managed medically - Cardiovascular surgery in the past 6 months or planned - Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants - Angina pectoris - Dizziness - Tinnitus - Blurred vision, vertigo, undiagnosed sensory and motor disturbances - Radicular symptoms and signs - Current use of anticoagulant therapy - Upper respiratory infection - Neck pain on provocation greater than 7 out of 10 - Provocation of radicular pain or sensory disturbance - Hypermobility of multiple peripheral joints, - Physical or mental impairment precluding following instructions or participating -in supine recumbent postures |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Canadian Memorial Chiropractic College | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Canadian Memorial Chiropractic College | National Center for Complementary and Integrative Health (NCCIH) |
Canada,
Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants with Adverse Events as a Measure of Safety | All adverse events will be described and tallied. Adverse events will be categorized in two modes: 1] Serious vs. Not Serious, and, 2] Attributable to the trial vs. Not Attributable. Both the absolute number of adverse events as well as the percentage of subjects experiencing an adverse event will be reported. | Daily over 7-10 days. | Yes |
Other | Expectations related to improvement | Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al. | Baseline | No |
Primary | Group registration | Participants will be asked to identify which of the two interventions they feel they received. | At exit assessment following the third intervention session | No |
Secondary | Pain severity | Pain scores on the PROMIS pain severity instrument. | 1. at baseline, and 2. At exit assessment following the third intervention session | No |
Secondary | Improvement | Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument. | At exit assessment following the third intervention session | No |
Secondary | Disability | Participants will score the The Neck Disability Index (score out of 50). | 1. at baseline, and 2. At exit assessment following the third intervention session | No |
Secondary | Tenderness | Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm. | 1. at baseline, and 2. At exit assessment following the third intervention session | No |
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