Chiropractic Manual Therapy and Neck Pain

Sponsor

Canadian Memorial Chiropractic College (Other)

Overall Status

Completed

CT.gov ID

NCT01772966

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

319

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Mechanical Neck Pain	Procedure: Spinal manipulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

319 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Group registration [At exit assessment following the third intervention session]
Participants will be asked to identify which of the two interventions they feel they received.

Secondary Outcome Measures

Pain severity [1. at baseline, and 2. At exit assessment following the third intervention session]
Pain scores on the PROMIS pain severity instrument.
Improvement [At exit assessment following the third intervention session]
Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
Disability [1. at baseline, and 2. At exit assessment following the third intervention session]
Participants will score the The Neck Disability Index (score out of 50).
Tenderness [1. at baseline, and 2. At exit assessment following the third intervention session]
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 [Daily over 7-10 days.]
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 [Baseline]
Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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