Chiropractic Manual Therapy and Neck Pain

This study is not yet open for participant recruitment.
Verified January 2013 by Canadian Memorial Chiropractic College
Sponsor:
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
  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 April 17, 2014