Validation of a Novel Sham Cervical Spinal Manipulation Procedure
|ClinicalTrials.gov Identifier: NCT00978094|
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : November 17, 2010
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
- Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
- there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
|Condition or disease|
|Chronic Neck Pain|
- Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
- Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
- Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
- Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Validation of a Novel Sham Cervical Spinal Manipulation Procedure.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
- The perception by subjects as to whether they received a real treatment (YES/NO) [ Time Frame: 10 mins ]
- Change scores of the pressure algometry [ Time Frame: 10 mins ]
- Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score [ Time Frame: approximately 1 hours + ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978094
|Canadian Memorial Chiropractic College|
|Toronto, Ontario, Canada, M2H 3J1|
|Principal Investigator:||Howard Vernon, BA, DC, PhD, FCCS, FCCRS||CMCC|