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Chiropractic Manual Therapy and Neck Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014