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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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neck Pain |
Procedure: manipulation Procedure: Mobilisation Device: Activator instrument |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neck Pain Comparative Study |
- Patient Global Impression of Change [ Time Frame: end of treatment, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
- Numerical rating scale for pain [ Time Frame: end of treatment, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
- Bournemouth Questionnaire [ Time Frame: end of treatment, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
- Adverse effects to treatment [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
- SF-36 version 2 [ Time Frame: end of treatment, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United Kingdom | |
| Anglo-European College of Chiropractic Out Patient Clinic | |
| Bournemouth, Dorset, United Kingdom, BH5 2DF | |
| Principal Investigator: | Hugh A Gemmell, DC. EdD | AECC |
More Information
No publications provided
| Responsible Party: | Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT01029951 History of Changes |
| Other Study ID Numbers: | A.06-2 |
| Study First Received: | December 9, 2009 |
| Last Updated: | December 9, 2009 |
| Health Authority: | United Kingdom: National Institute for Health Research |
Keywords provided by Anglo-European College of Chiropractic:
|
Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial Subacute non-specific neck pain |
Additional relevant MeSH terms:
|
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013