Clinical trial NCT01772966: Chiropractic Manual Therapy and Neck Pain
Official title: Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Mechanical Neck Pain
Keywords: neck
pain
chronic
manipulation
control
randomized trial
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-01-21
Enrollment: 319
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Group registration
timeFrame: At exit assessment following the third intervention session
Secondary outcomes:
measure: Pain severity
timeFrame: 1. at baseline, and 2. At exit assessment following the third intervention session
measure: Improvement
timeFrame: At exit assessment following the third intervention session
measure: Disability
timeFrame: 1. at baseline, and 2. At exit assessment following the third intervention session
measure: Tenderness
timeFrame: 1. at baseline, and 2. At exit assessment following the third intervention session
Other outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: Daily over 7-10 days.
measure: Expectations related to improvement
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
affiliation: Canadian Memorial Chiropractic College
name: Howard T Vernon, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.