Neck PainSKMNCT02651766
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial
A study testing Cupping massage in people with Neck Pain and Mechanical/Motor Problems With Neck and Trunk, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Mechanical/Motor Problems With Neck and Trunk
- What is being tested?
- Cupping massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to 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
- age between 18 and 75
- permanent neck pain for at least three months in a row
- a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)
Who cannot join
- neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
- invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
- serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
- non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial on the Influence of Cupping Massage on Pain Intensity and Sensory Mechanical and Pain Thresholds in Patients With Chronic Non Specific Neck Pain
The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.
The treatment group receives 5 cupping treatments over a period of 3 weeks.
Read the detailed description
see above
- Being tested
- Cupping massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupping massageProcedure or surgery
Also called Moving cupping treatment
Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin
| Study group | Role | What they receive |
|---|---|---|
| Waiting List control group | No intervention | No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study |
| Cupping massage treatment | Experimental | Received the 5 cupping treatments, application twice a week on the upper back and neck Receives: Procedure: Cupping massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'
Measured: 3 weeks
Secondary outcomes (8)
Pain on movement (POM)
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain' Intensity rated for 6 movement directions flexion, tension, and rotation
Measured: 3 weeks
Neck disability index
NDI measures neck pain complaints (Vernon und Mior 1991)
Measured: 3 weeks
Quality of Life SF-36
the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger \& Kirchberger 1998)
Measured: 3 weeks
mechanical detection threshold MDT
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
Measured: 3 weeks
vibration detection threshold VDT
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
Measured: 3 weeks
pressure pain threshold PPT
with a pressure gauge algometer to determine threshold for painful pressure (Rolke, Pain, 2006) on the area of maximal neck pain, the adjacent and hand and foot
Measured: 3 weeks
Adverse events
Number of patients with adverse events
Measured: 3 weeks
two point discrimination threshold
using a pair of circles, determining the distance necessary between those to perceive them as separate sensations
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- GUstav Dobos, Prof MD, Principal investigator, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651766
- Sponsor's protocol ID
- 09-3987-BO
- Acronym
- SKM
- Status last verified
- Apr 2018
- First submitted
- 7 Jan 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Saha FJ, Schumann S, Cramer H, Hohmann C, Choi KE, Rolke R, Langhorst J, Rampp T, Dobos G, Lauche R. The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res. 2017;24(1):26-32. doi: 10.1159/000454872. Epub 2017 Feb 15.
PubMed 28219058Schumann S, Lauche R, Hohmann C, Zirbes T, Dobos G, Saha FJ. [Development of lipoma following a single cupping massage - a case report]. Forsch Komplementmed. 2012;19(4):202-5. doi: 10.1159/000341869. Epub 2012 Aug 20. German.
PubMed 22964987Schumann S, Lauche R, Irmisch G, Hohmann C, Rolke R, Saha F, Cramer H, Choi KE, Langhorst J, Rampp T, Dobos G, Musial F. The effects of 5 sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study. BMC Complementary and Alternative Medicine, 2012, 12 (Supplement 1): 80.
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
- Randomised Controlled Trial on the Influence of Cupping Massage on Pain Intensity and Sensory Mechanical and Pain Thresholds in Patients With Chronic Non Specific Neck Pain
- ClinicalTrials.gov ID
- NCT02651766
- Acronym / sponsor ID
- SKM / 09-3987-BO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jan 2016 (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.
The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.
The treatment group receives 5 cupping treatments over a period of 3 weeks.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting List control group | No intervention | –No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study |
| Cupping massage treatment | Experimental | Procedure: Cupping massageReceived the 5 cupping treatments, application twice a week on the upper back and neck |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75
- permanent neck pain for at least three months in a row
- a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)
Key exclusion criteria (4 listed)
- neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
- invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
- serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
- non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
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 |
|---|---|---|
| Cupping massageAlso: Moving cupping treatmentUsing suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin | Procedure or surgery | Cupping massage treatment |
Primary outcome
Pain intensity
Time frame: 3 weeks
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'
8 secondary outcomes
Pain on movement (POM)
Time frame: 3 weeks
Neck disability index
Time frame: 3 weeks
Quality of Life SF-36
Time frame: 3 weeks
mechanical detection threshold MDT
Time frame: 3 weeks
vibration detection threshold VDT
Time frame: 3 weeks
pressure pain threshold PPT
Time frame: 3 weeks
Adverse events
Time frame: 3 weeks
two point discrimination threshold
Time frame: 3 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.
- Background: PubMed 28219058Saha FJ, Schumann S, Cramer H, Hohmann C, Choi KE, Rolke R, Langhorst J, Rampp T, Dobos G, Lauche R. The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res. 2017;24(1):26-32. doi: 10.1159/000454872. Epub 2017 Feb 15.
- Results publication: PubMed 22964987Schumann S, Lauche R, Hohmann C, Zirbes T, Dobos G, Saha FJ. [Development of lipoma following a single cupping massage - a case report]. Forsch Komplementmed. 2012;19(4):202-5. doi: 10.1159/000341869. Epub 2012 Aug 20. German.
- Results publicationSchumann S, Lauche R, Irmisch G, Hohmann C, Rolke R, Saha F, Cramer H, Choi KE, Langhorst J, Rampp T, Dobos G, Musial F. The effects of 5 sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study. BMC Complementary and Alternative Medicine, 2012, 12 (Supplement 1): 80.
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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.
GUstav Dobos, Prof MD principal investigator
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cupping massage in people with Neck Pain and Mechanical/Motor Problems With Neck and Trunk, 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 4 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?
Pain intensity (time frame: 3 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 NCT02651766, which also lists 3 linked publications.
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.