Chiropractic Manual Therapy and Neck Pain

Chronic Mechanical Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772966
• Other study ID #: 122008
• Secondary ID: R01AT007311-01
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: October 27, 2016
• Start date: February 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Mechanical Neck Pain
• Neck Pain

Intervention

Procedure:
• Spinal manipulation

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events as a Measure of Safety	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.	Daily over 7-10 days.	Yes
Other	Expectations related to improvement	Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.	Baseline	No
Primary	Group registration	Participants will be asked to identify which of the two interventions they feel they received.	At exit assessment following the third intervention session	No
Secondary	Pain severity	Pain scores on the PROMIS pain severity instrument.	1. at baseline, and 2. At exit assessment following the third intervention session	No
Secondary	Improvement	Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.	At exit assessment following the third intervention session	No
Secondary	Disability	Participants will score the The Neck Disability Index (score out of 50).	1. at baseline, and 2. At exit assessment following the third intervention session	No
Secondary	Tenderness	Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.	1. at baseline, and 2. At exit assessment following the third intervention session	No