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

This study has been completed.
Sponsor:
Collaborators:
European Chiropractors Union
National Institute for Chiropractic Research
Information provided by:
Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01029951
First received: December 9, 2009
Last updated: NA
Last verified: July 2006
History: No changes posted

December 9, 2009
December 9, 2009
January 2007
March 2009   (final data collection date for primary outcome measure)
Patient Global Impression of Change [ Time Frame: end of treatment, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neck Pain
  • Procedure: manipulation
  • Procedure: Mobilisation
  • Device: Activator instrument
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01029951
A.06-2
No
Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
Anglo-European College of Chiropractic
  • European Chiropractors Union
  • National Institute for Chiropractic Research
Principal Investigator: Hugh A Gemmell, DC. EdD AECC
Anglo-European College of Chiropractic
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP