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
  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

Resource links provided by NLM:


Further study details as provided by Anglo-European College of Chiropractic:

Primary Outcome Measures:
  • Patient Global Impression of Change [ Time Frame: end of treatment, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029951

Locations
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
Investigators
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 July 28, 2014