Chiropractic Manual Therapy and Neck Pain

Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Mechanical Neck Pain
• Intervention / Treatment: Procedure: Spinal manipulation

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2H 3J1
      • Canadian Memorial Chiropractic College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	Pain scores on the PROMIS pain severity instrument.	1. at baseline, and 2. At exit assessment following the third intervention session
Improvement	Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.	At exit assessment following the third intervention session
Disability	Participants will score the The Neck Disability Index (score out of 50).	1. at baseline, and 2. At exit assessment following the third intervention session
Tenderness	Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.	1. at baseline, and 2. At exit assessment following the third intervention session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety	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.	Daily over 7-10 days.
Expectations related to improvement	Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.	Baseline

Collaborators and Investigators

• Sponsor: Canadian Memorial Chiropractic College
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Howard T Vernon, DC, PhD, Canadian Memorial Chiropractic College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pain; randomized trial; chronic; control; neck; manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 122008; R01AT007311-01 (U.S. NIH Grant/Contract)