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OpenTrials
Completed

NCT Number: NCT01772966

Chiropractic Manual Therapy and 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.

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Key information

Conditions

Chronic Mechanical Neck Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal manipulation

Procedure

Primary outcomes

  1. Group registration

    Time frame: At exit assessment following the third intervention session

    Participants will be asked to identify which of the two interventions they feel they received.

Secondary outcomes

  1. Pain severity

    Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session

    Pain scores on the PROMIS pain severity instrument.

  2. Improvement

    Time frame: 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.

  3. Disability

    Time frame: 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).

  4. Tenderness

    Time frame: 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 outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety

    Time frame: 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.

  2. Expectations related to improvement

    Time frame: Baseline

    Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.

Sponsors and collaborators

Lead sponsor

Canadian Memorial Chiropractic College

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2013
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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