Chiropractic Manual Therapy and Neck Pain

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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