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

NCT ID: NCT01029951

Last Updated: 2009-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

manipulation

Intervention Type: PROCEDURE

Mobilisation

Intervention Type: PROCEDURE

Activator instrument

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Chiropractors Union

UNKNOWN

Sponsor Role: collaborator

National Institute for Chiropractic Research

UNKNOWN

Sponsor Role: collaborator

Anglo-European College of Chiropractic

OTHER

Sponsor Role: lead

Responsible Party

Anglo-European College of Chiropractic

Principal Investigators

Hugh A Gemmell, DC. EdD

Role: PRINCIPAL_INVESTIGATOR

Asociación Española contra el Cáncer

Locations

Anglo-European College of Chiropractic Out Patient Clinic

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

A.06-2

Identifier Type: -

Identifier Source: org_study_id