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Chiropractic Manual Therapy and Neck Pain

Primary Purpose

Chronic Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spinal manipulation
Sponsored by
Canadian Memorial Chiropractic College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Mechanical Neck Pain focused on measuring neck, pain, chronic, manipulation, control, randomized trial

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Canadian Memorial Chiropractic College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal manipulation

Control manipulation

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain severity
Pain scores on the PROMIS pain severity instrument.
Improvement
Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
Disability
Participants will score the The Neck Disability Index (score out of 50).
Tenderness
Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.

Full Information

First Posted
September 21, 2012
Last Updated
October 27, 2016
Sponsor
Canadian Memorial Chiropractic College
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01772966
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Memorial Chiropractic College
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Mechanical Neck Pain
Keywords
neck, pain, chronic, manipulation, control, randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal manipulation
Arm Type
Experimental
Arm 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.
Arm Title
Control manipulation
Arm Type
Sham Comparator
Arm Description
Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation
Primary Outcome Measure Information:
Title
Group registration
Description
Participants will be asked to identify which of the two interventions they feel they received.
Time Frame
At exit assessment following the third intervention session
Secondary Outcome Measure Information:
Title
Pain severity
Description
Pain scores on the PROMIS pain severity instrument.
Time Frame
1. at baseline, and 2. At exit assessment following the third intervention session
Title
Improvement
Description
Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
Time Frame
At exit assessment following the third intervention session
Title
Disability
Description
Participants will score the The Neck Disability Index (score out of 50).
Time Frame
1. at baseline, and 2. At exit assessment following the third intervention session
Title
Tenderness
Description
Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.
Time Frame
1. at baseline, and 2. At exit assessment following the third intervention session
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events as a Measure of Safety
Description
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.
Time Frame
Daily over 7-10 days.
Title
Expectations related to improvement
Description
Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard T Vernon, DC, PhD
Organizational Affiliation
Canadian Memorial Chiropractic College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Memorial Chiropractic College
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2H 3J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16326235
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.
Results Reference
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Chiropractic Manual Therapy and Neck Pain

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