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
Neck Pain Comparative Study
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedDecember 10, 2009
July 1, 2006
2.2 years
December 9, 2009
December 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Global Impression of Change
end of treatment, 3 months, 6 months and 12 months
Secondary Outcomes (4)
Numerical rating scale for pain
end of treatment, 3 months, 6 months, and 12 months
Bournemouth Questionnaire
end of treatment, 3 months, 6 months, and 12 months
Adverse effects to treatment
end of treatment
SF-36 version 2
end of treatment, 3 months, 6 months and 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anglo-European College of Chiropracticlead
- European Chiropractors Unioncollaborator
- National Institute for Chiropractic Researchcollaborator
Study Sites (1)
Anglo-European College of Chiropractic Out Patient Clinic
Bournemouth, Dorset, BH5 2DF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh A Gemmell, DC. EdD
Asociación Española contra el Cáncer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 10, 2009
Study Start
January 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 10, 2009
Record last verified: 2006-07