Neck PainNCT01233180
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
A study testing Gua Sha and Thermotherapy in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a round-edged instrument until small petechiae appear. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Gua Sha and Thermotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Feb 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic mechanical neck pain, at least 40 mm on a 100mm visual analog scale.
- Pain for at least 3 months.
Who cannot join
- radicular symptoms
- congenital spine deformity
- pregnancy
- rheumatic diseases
- oncologic diseases
- other severe psychiatric or somatic comorbidity
Show all 9Show fewer
- recent invasive or surgical treatment of the spine
- participation in other studies
- skin diseases in the area to be treated
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Randomized Controlled Trial Comparing Gua Sha Massage and Thermotherapy for Chronic Neck Pain: Effects on Pain Intensity, Haptic Perception and Body Image.
Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a round-edged instrument until small petechiae appear. This so called "sha", considered as the removal of blood stasis by traditional practitioners, will fade within a few days. Normally, this treatment is not considered as painful, but as relaxing and easing tense muscles.
In this study, the investigators will investigate the effectivity of Gua Sha massage in treating chronic neck pain. The investigators will research effects on subjective pain intensity, neck pain specific disability and haptic perception.
- Conditions
- Neck Pain
- Being tested
- Gua Sha, Thermotherapy
- Keywords
- neck pain, massage, hyperthermia, induced, touch perception, randomized controlled trial
- Medical subject headings
- Neck Pain, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gua ShaOther
Single Gua Sha treatment of the neck and shoulder region
ThermotherapyDevice
Single use of a mud heat pad on the neck and shoulder region
| Study group | Role | What they receive |
|---|---|---|
| Gua Sha | Active comparator | Single Gua Sha treatment of the neck and shoulder region. Receives: Other: Gua Sha |
| Thermotherapy | Active comparator | Single use of a mud heat pad on the neck and shoulder region. Receives: Device: Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity (100mm visual analog scale)
Measured: Day 4
Secondary outcomes (2)
Neck disability index (NDI)
The Neck Disability Index is an instrument to assess neck pain complaints.
Reference: Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther 1991;14:409-415.
Measured: Day 4
Haptic perception
The design consists of two angle legs, of which one angle leg has to be readjusted to a given angle adjustment. This is done by haptic perception without visual feedback. The deviation of the adjusted angle from the locked angle is measured.
Reference: Grunwald, M., Ettich, C., Busse, F., Assmann, B., Dähne, A., Gertz, H.-J., (2002): Angle paradigm: A new method to measure right parietal dysfunctions in anorexia nervosa. Archives of Clinical Neuropsychology , 17, pp. 485- 496
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233180
- Sponsor's protocol ID
- 10-4434
- Status last verified
- Feb 2011
- First submitted
- 2 Nov 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Gua Sha Massage and Thermotherapy for Chronic Neck Pain: Effects on Pain Intensity, Haptic Perception and Body Image.
- ClinicalTrials.gov ID
- NCT01233180
- Acronym / sponsor ID
- 10-4434
- Conditions
- Neck Pain
- Keywords
- neck pain, massage, hyperthermia, induced, touch perception, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Nov 2010 (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.
Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a round-edged instrument until small petechiae appear. This so called "sha", considered as the removal of blood stasis by traditional practitioners, will fade within a few days. Normally, this treatment is not considered as painful, but as relaxing and easing tense muscles.
In this study, the investigators will investigate the effectivity of Gua Sha massage in treating chronic neck pain. The investigators will research effects on subjective pain intensity, neck pain specific disability and haptic perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gua Sha | Active comparator | Other: Gua ShaSingle Gua Sha treatment of the neck and shoulder region. |
| Thermotherapy | Active comparator | Device: ThermotherapySingle use of a mud heat pad on the neck and shoulder region. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic mechanical neck pain, at least 40 mm on a 100mm visual analog scale.
- Pain for at least 3 months.
Key exclusion criteria (9 listed)
- radicular symptoms
- congenital spine deformity
- pregnancy
- rheumatic diseases
- oncologic diseases
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 |
|---|---|---|
| Gua ShaSingle Gua Sha treatment of the neck and shoulder region | Other | Gua Sha |
| ThermotherapySingle use of a mud heat pad on the neck and shoulder region | Device | Thermotherapy |
Primary outcome
Neck pain intensity (100mm visual analog scale)
Time frame: Day 4
2 secondary outcomes
Neck disability index (NDI)
Time frame: Day 4
Haptic perception
Time frame: Day 4
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 23 Feb 2011.
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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 Gua Sha and Thermotherapy in people with 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 2 inclusion and 9 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 23 Feb 2011. 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 (100mm visual analog scale) (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2011.