Chronic Non-specific Neck PainATNeckNCT02209480
Alexander Technique Neck Pain
A study testing Alexander Technique, Heat pad application and guided imagery in people with Chronic Non-specific Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- Alexander Technique, Heat pad application and guided imagery
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic non-specific neck pain
- at least 3 months
- 40mm pain intensity on visual analog scale
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: 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.
Read the detailed description
see above
- Conditions
- Chronic Non-specific Neck Pain
- Being tested
- Alexander Technique, Heat pad application, guided imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexander TechniqueBehavioural
Heat pad applicationDevice
guided imageryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Alexander Technique | Experimental | 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 Receives: Behavioral: Alexander Technique |
| Heat pad application | Active comparator | 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. Receives: Device: Heat pad application |
| guided imagery | Active comparator | guided imagery relaxation technique , 45 minutes, 5 sessions in weekly rhythm including body scan, breathing relaxation, visualization Receives: Behavioral: guided imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck pain intensity
neck pain intensity measured on a 100mm visual analog scales
- comparison Alexander technique vs. heat pad
- comparison Alexander technique vs. guided imagery
Measured: 5 weeks
Secondary outcomes (6)
quality of life
quality of life measured by the SF-36 questionnaire
Measured: 5 weeks
Pain on motion
pain on motion (movement of head in different directions) measured by the POM (Lauche, 2014, pain medicine)
Measured: 5 weeks
Medication
weekly dose of medication calculated as the defined daily dose according to WHO
Measured: 5 weeks
functional disability
measured by the neck disability index (NDI)
Measured: 5 weeks
satisfaction
satisfaction measured on a visual analog scale and via questions like "would you consider using it again" or "would you recommend it"
Measured: 5 weeks
safety
any adverse event during the study period
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209480
- Sponsor's protocol ID
- 07-3497
- Acronym
- ATNeck
- Status last verified
- Apr 2018
- First submitted
- 4 Aug 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauche R, Schuth M, Schwickert M, Ludtke R, Musial F, Michalsen A, Dobos G, Choi KE. Efficacy of the Alexander Technique in treating chronic non-specific neck pain: a randomized controlled trial. Clin Rehabil. 2016 Mar;30(3):247-58. doi: 10.1177/0269215515578699. Epub 2015 Mar 31.
PubMed 25834276
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of F.M. Alexander Technique in Chronic Neck Pain Patients
- ClinicalTrials.gov ID
- NCT02209480
- Acronym / sponsor ID
- ATNeck / 07-3497
- Conditions
- Chronic Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alexander Technique | Experimental | Behavioral: Alexander Technique5 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 |
| Heat pad application | Active comparator | Device: Heat pad application5 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. |
| guided imagery | Active comparator | Behavioral: guided imageryguided imagery relaxation technique , 45 minutes, 5 sessions in weekly rhythm including body scan, breathing relaxation, visualization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- chronic non-specific neck pain
- at least 3 months
- 40mm pain intensity on visual analog scale
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alexander Technique | Behavioural | Alexander Technique |
| Heat pad application | Device | Heat pad application |
| guided imagery | Behavioural | guided imagery |
Primary outcome
neck pain intensity
Time frame: 5 weeks
neck pain intensity measured on a 100mm visual analog scales 1. comparison Alexander technique vs. heat pad 2. comparison Alexander technique vs. guided imagery
6 secondary outcomes
quality of life
Time frame: 5 weeks
Pain on motion
Time frame: 5 weeks
Medication
Time frame: 5 weeks
functional disability
Time frame: 5 weeks
satisfaction
Time frame: 5 weeks
safety
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Results publication: PubMed 25834276Lauche R, Schuth M, Schwickert M, Ludtke R, Musial F, Michalsen A, Dobos G, Choi KE. Efficacy of the Alexander Technique in treating chronic non-specific neck pain: a randomized controlled trial. Clin Rehabil. 2016 Mar;30(3):247-58. doi: 10.1177/0269215515578699. Epub 2015 Mar 31.
Related trials for Chronic Non-specific Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Recruiting
Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain
Chronic Non-specific Neck Pain
Recruiting
Clinical and Brain Activity Assessment Before and After Physiotherapy in People With Chronic Non-specific Neck Pain
Neck Pain Musculoskeletal, Chronic Neck Pain
Recruiting
Effects of Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain
Chronic Non-specific Neck Pain
Not yet recruiting
Effect of Cervical Force Control Training on Force Sense and Steadiness in Chronic Non-Specific Neck Pain
Chronic Non-specific Neck Pain, Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexander Technique, Heat pad application and guided imagery in people with Chronic Non-specific Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck pain intensity (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.