Back to resultsRelative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
manipulation
Mobilisation
Activator instrument
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial, Subacute non-specific neck pain
Eligibility Criteria
Inclusion Criteria:
- age 18-64 years; a new or recurrent episode of neck pain present for more than 4 weeks, but no longer than 12 weeks;
- neck pain that could extend to the shoulder region or upper extremities, and be accompanied by headache, but neck pain was more painful;
- the patient agreed not to take medication or receive other treatment for neck pain during the course of the study (paracetamol 500 mg 4 times a day was allowed as rescue medication);
- and a baseline pain level of at least 4 on the 11-point numerical rating scale.
Exclusion Criteria:
- Exclusion criteria were treatment with any of the interventions during 6 months prior to recruitment to the study; specific neck pain due to fracture, neoplasm, infection, inflammatory arthropathy, radiculopathy or myelopathy;
- factors contraindicating manipulation, such as blood coagulation disorders, long-term use of corticosteroids, anticoagulant medications, history of neck surgery, stroke or transient ischaemic attacks; plans to relocate;
- inability to read or understand English;
- and third-party liability or workers' compensation claims.
Sites / Locations
- Anglo-European College of Chiropractic Out Patient Clinic
Outcomes
Primary Outcome Measures
Patient Global Impression of Change
Secondary Outcome Measures
Numerical rating scale for pain
Bournemouth Questionnaire
Adverse effects to treatment
SF-36 version 2
Full Information
NCT ID
NCT01029951
First Posted
December 9, 2009
Last Updated
December 9, 2009
Sponsor
Anglo-European College of Chiropractic
Collaborators
European Chiropractors Union, National Institute for Chiropractic Research
1. Study Identification
Unique Protocol Identification Number
NCT01029951
Brief Title
Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
Official Title
Neck Pain Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Anglo-European College of Chiropractic
Collaborators
European Chiropractors Union, National Institute for Chiropractic Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments.
Detailed Description
Neck pain is a common disorder. About 70% of adults will experience neck pain during their lifetime. After low back pain, neck pain is the most common reason patients give for seeking chiropractic care, and the second most common reason for the use of spinal manipulation. Usually, the underlying cause of neck pain is non-specific and cannot be related to a particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the results obtained in the limited number of studies of manipulation and mobilisation for neck pain, further studies are needed to compare the different therapies available for neck pain. Participants in the study were treated as they would normally be with the exception of the type of spinal manipulation. There were three groups: a manipulation group, a mobilisation group, and an Activator instrument group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial, Subacute non-specific neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
manipulation
Intervention Type
Procedure
Intervention Name(s)
Mobilisation
Intervention Type
Device
Intervention Name(s)
Activator instrument
Primary Outcome Measure Information:
Title
Patient Global Impression of Change
Time Frame
end of treatment, 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Numerical rating scale for pain
Time Frame
end of treatment, 3 months, 6 months, and 12 months
Title
Bournemouth Questionnaire
Time Frame
end of treatment, 3 months, 6 months, and 12 months
Title
Adverse effects to treatment
Time Frame
end of treatment
Title
SF-36 version 2
Time Frame
end of treatment, 3 months, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-64 years; a new or recurrent episode of neck pain present for more than 4 weeks, but no longer than 12 weeks;
neck pain that could extend to the shoulder region or upper extremities, and be accompanied by headache, but neck pain was more painful;
the patient agreed not to take medication or receive other treatment for neck pain during the course of the study (paracetamol 500 mg 4 times a day was allowed as rescue medication);
and a baseline pain level of at least 4 on the 11-point numerical rating scale.
Exclusion Criteria:
Exclusion criteria were treatment with any of the interventions during 6 months prior to recruitment to the study; specific neck pain due to fracture, neoplasm, infection, inflammatory arthropathy, radiculopathy or myelopathy;
factors contraindicating manipulation, such as blood coagulation disorders, long-term use of corticosteroids, anticoagulant medications, history of neck surgery, stroke or transient ischaemic attacks; plans to relocate;
inability to read or understand English;
and third-party liability or workers' compensation claims.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh A Gemmell, DC. EdD
Organizational Affiliation
Asociación Española contra el Cáncer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglo-European College of Chiropractic Out Patient Clinic
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH5 2DF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
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