Chiropractic Manual Therapy and Neck Pain
|ClinicalTrials.gov Identifier: NCT01772966|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : October 31, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Mechanical Neck Pain||Procedure: Spinal manipulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Spinal manipulation
Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days.
|Procedure: Spinal manipulation|
Sham Comparator: Control manipulation
Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.
|Procedure: Spinal manipulation|
- Group registration [ Time Frame: At exit assessment following the third intervention session ]Participants will be asked to identify which of the two interventions they feel they received.
- Pain severity [ Time Frame: 1. at baseline, and 2. At exit assessment following the third intervention session ]Pain scores on the PROMIS pain severity instrument.
- Improvement [ Time Frame: At exit assessment following the third intervention session ]Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
- Disability [ Time Frame: 1. at baseline, and 2. At exit assessment following the third intervention session ]Participants will score the The Neck Disability Index (score out of 50).
- Tenderness [ Time Frame: 1. at baseline, and 2. At exit assessment following the third intervention session ]Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: Daily over 7-10 days. ]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.
- Expectations related to improvement [ Time Frame: Baseline ]Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772966
|Canadian Memorial Chiropractic College|
|Toronto, Ontario, Canada, M2H 3J1|
|Principal Investigator:||Howard T Vernon, DC, PhD||Canadian Memorial Chiropractic College|