Skip to main content
OpenTrials
Completed

NCT Number: NCT01029951

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anglo-European College of Chiropractic Out Patient Clinic

Bournemouth, Dorset, BH5 2DF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manipulation

Procedure

Mobilisation

Procedure

Activator instrument

Device

Primary outcomes

  1. Patient Global Impression of Change

    Time frame: end of treatment, 3 months, 6 months and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Anglo-European College of Chiropractic

Other

Collaborators

  • European Chiropractors Union
  • National Institute for Chiropractic Research

Registry information

Official study title

Neck Pain Comparative Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 10, 2009
Registry last updated
Dec 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.