Chiropractic Manual Therapy and Neck Pain
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|