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 Clinical Trial

Official title:

Neck Pain Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029951
• Other study ID #: A.06-2
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: December 9, 2009
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2006
• Source: Anglo-European College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• manipulation

• Mobilisation

Device:
• Activator instrument

Locations

Country	Name	City	State
United Kingdom	Anglo-European College of Chiropractic Out Patient Clinic	Bournemouth	Dorset

Sponsors (3)

Lead Sponsor	Collaborator
Anglo-European College of Chiropractic	European Chiropractors Union, National Institute for Chiropractic Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change		end of treatment, 3 months, 6 months and 12 months	No
Secondary	Numerical rating scale for pain		end of treatment, 3 months, 6 months, and 12 months	No
Secondary	Bournemouth Questionnaire		end of treatment, 3 months, 6 months, and 12 months	No
Secondary	Adverse effects to treatment		end of treatment	Yes
Secondary	SF-36 version 2		end of treatment, 3 months, 6 months and 12 months	No