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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029951
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : December 10, 2009
European Chiropractors Union
National Institute for Chiropractic Research
Information provided by:
Anglo-European College of Chiropractic

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.

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: manipulation Procedure: Mobilisation Device: Activator instrument Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neck Pain Comparative Study
Study Start Date : January 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patient Global Impression of Change [ Time Frame: end of treatment, 3 months, 6 months and 12 months ]

Secondary Outcome Measures :
  1. Numerical rating scale for pain [ Time Frame: end of treatment, 3 months, 6 months, and 12 months ]
  2. Bournemouth Questionnaire [ Time Frame: end of treatment, 3 months, 6 months, and 12 months ]
  3. Adverse effects to treatment [ Time Frame: end of treatment ]
  4. SF-36 version 2 [ Time Frame: end of treatment, 3 months, 6 months and 12 months ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029951

United Kingdom
Anglo-European College of Chiropractic Out Patient Clinic
Bournemouth, Dorset, United Kingdom, BH5 2DF
Sponsors and Collaborators
Anglo-European College of Chiropractic
European Chiropractors Union
National Institute for Chiropractic Research
Principal Investigator: Hugh A Gemmell, DC. EdD AECC

Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic Identifier: NCT01029951     History of Changes
Other Study ID Numbers: A.06-2
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: December 10, 2009
Last Verified: July 2006

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
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms