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

December 9, 2009 updated by: Anglo-European College of Chiropractic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH5 2DF
        • Anglo-European College of Chiropractic Out Patient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Global Impression of Change
Time Frame: end of treatment, 3 months, 6 months and 12 months
end of treatment, 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Numerical rating scale for pain
Time Frame: end of treatment, 3 months, 6 months, and 12 months
end of treatment, 3 months, 6 months, and 12 months
Bournemouth Questionnaire
Time Frame: end of treatment, 3 months, 6 months, and 12 months
end of treatment, 3 months, 6 months, and 12 months
Adverse effects to treatment
Time Frame: end of treatment
end of treatment
SF-36 version 2
Time Frame: end of treatment, 3 months, 6 months and 12 months
end of treatment, 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo-European College of Chiropractic

Collaborators

European Chiropractors Union
National Institute for Chiropractic Research

Investigators

  • Principal Investigator: Hugh A Gemmell, DC. EdD, Asociación Española contra el Cáncer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (ESTIMATE)

December 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A.06-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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