Chiropractic Manual Therapy and Neck Pain

Canadian Memorial Chiropractic College

Status: Completed

Conditions: Chronic Mechanical Neck Pain

Treatments: Procedure: Spinal manipulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01772966

122008

R01AT007311-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 2 patient groups

Spinal manipulation

Experimental group

Description:

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.

Treatment:

Procedure: Spinal manipulation

Control manipulation

Sham Comparator group

Description:

Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.

Treatment:

Procedure: Spinal manipulation