- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02209480
Alexander Technique Neck Pain (ATNeck)
April 30, 2018 updated by: Romy Lauche, Universität Duisburg-Essen
Randomized Controlled Trial on the Efficacy of F.M. Alexander Technique in Chronic Neck Pain Patients
This study aimed to test the efficacy of five Alexander Technique lessons compared to the same period of heat pad application and guided imagery in patients with chronic non-specific neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
see above
Study Type
Interventional
Enrollment (Actual)
72
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
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Essen, Germany, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic non-specific neck pain
- at least 3 months
- 40mm pain intensity on visual analog scale
Exclusion Criteria:
- neck pain as consequence of disc protrusion or prolapse, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, neurological disorder,
- active oncologic disease
- affective disorder
- addiction
- psychosis.
- pregnancy
- invasive treatment of the spine within the previous three weeks
- spinal surgery
- previous experiences in Alexander Technique
- ongoing application for disability pension
- simultaneous participation in other clinical trials on neck pain
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alexander Technique
5 lessons of AT, each lasting up to 45 minutes, weekly intervals The lessons aimed at sensory awareness of everyday movements and movement sequences, such as sitting, walking, lying, or lifting in order to replace habitual patterns using conscious control; and different techniques were applied, such as demonstration, verbal instructions, hands on techniques and others
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|
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Active Comparator: Heat pad application
5 treatments by means of a heat pad, 15-0 minutes, sitting or lying position, quiet room Heat pad: Zapp-Sack® contained certain grains and a ginger extract, and could be heated up in the microwave.
|
|
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Active Comparator: guided imagery
guided imagery relaxation technique , 45 minutes, 5 sessions in weekly rhythm including body scan, breathing relaxation, visualization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck pain intensity
Time Frame: 5 weeks
|
neck pain intensity measured on a 100mm visual analog scales
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: 5 weeks
|
quality of life measured by the SF-36 questionnaire
|
5 weeks
|
|
Pain on motion
Time Frame: 5 weeks
|
pain on motion (movement of head in different directions) measured by the POM (Lauche, 2014, pain medicine)
|
5 weeks
|
|
Medication
Time Frame: 5 weeks
|
weekly dose of medication calculated as the defined daily dose according to WHO
|
5 weeks
|
|
functional disability
Time Frame: 5 weeks
|
measured by the neck disability index (NDI)
|
5 weeks
|
|
satisfaction
Time Frame: 5 weeks
|
satisfaction measured on a visual analog scale and via questions like "would you consider using it again" or "would you recommend it"
|
5 weeks
|
|
safety
Time Frame: 5 weeks
|
any adverse event during the study period
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
August 4, 2014
First Submitted That Met QC Criteria
August 4, 2014
First Posted (Estimate)
August 6, 2014
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-3497
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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