Chiropractic Manual Therapy and Neck Pain
This study is not yet open for participant recruitment.
Verified January 2013 by Canadian Memorial Chiropractic College
Sponsor:
Canadian Memorial Chiropractic College
Collaborator:
Information provided by (Responsible Party):
Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT01772966
First received: September 21, 2012
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Chronic Mechanical Neck Pain |
Procedure: Spinal manipulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain |
Resource links provided by NLM:
Further study details as provided by Canadian Memorial Chiropractic College:
Primary Outcome Measures:
- Group registration [ Time Frame: At exit assessment following the third intervention session ] [ Designated as safety issue: No ]Participants will be asked to identify which of the two interventions they feel they received.
Secondary Outcome Measures:
- Pain severity [ Time Frame: 1. at baseline, and 2. At exit assessment following the third intervention session ] [ Designated as safety issue: No ]Pain scores on the PROMIS pain severity instrument.
- Improvement [ Time Frame: At exit assessment following the third intervention session ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.
Other Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: Daily over 7-10 days. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.
| Estimated Enrollment: | 372 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772966
Contacts
| Contact: Howard T Vernon, DC, PhD | 416-482-2340 ext 216 | hvernon@cmcc.ca |
| Contact: Mark Fillery | 416-482-2340 ext 267 | mfillery@cmcc.ca |
Locations
| Canada, Ontario | |
| Canadian Memorial Chiropractic College | Not yet recruiting |
| Toronto, Ontario, Canada, M2H 3J1 | |
| Contact: Howard T Vernon, DC, PhD 416-482-2340 ext 216 hvernon@cmcc.ca | |
| Contact: Mark Fillery 416-482-2340 ext 267 mfillery@cmcc.ca | |
| Sub-Investigator: John J Triano, DC, PhD | |
| Sub-Investigator: Anthony Tibbles, DC | |
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Investigators
| Principal Investigator: | Howard T Vernon, DC, PhD | Canadian Memorial Chiropractic College |
More Information
Publications:
| Responsible Party: | Canadian Memorial Chiropractic College |
| ClinicalTrials.gov Identifier: | NCT01772966 History of Changes |
| Other Study ID Numbers: | 122008, R01AT007311-01 |
| Study First Received: | September 21, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Canadian Memorial Chiropractic College:
|
neck pain chronic |
manipulation control randomized trial |
Additional relevant MeSH terms:
|
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013