Chiropractic Manual Therapy and Neck Pain
Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
2 other identifiers
interventional
319
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 31, 2016
October 1, 2016
3.5 years
September 21, 2012
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Pain severity
1. at baseline, and 2. At exit assessment following the third intervention session
Improvement
At exit assessment following the third intervention session
Disability
1. at baseline, and 2. At exit assessment following the third intervention session
Tenderness
1. at baseline, and 2. At exit assessment following the third intervention session
Other Outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety
Daily over 7-10 days.
Expectations related to improvement
Baseline
Study Arms (2)
Spinal manipulation
EXPERIMENTALParticipants 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.
Control manipulation
SHAM COMPARATORParticipants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3J1, Canada
Related Publications (1)
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. doi: 10.1016/j.jmpt.2005.07.020.
PMID: 16326235RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard T Vernon, DC, PhD
Canadian Memorial Chiropractic College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2012
First Posted
January 21, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 31, 2016
Record last verified: 2016-10