Neck PainTSNCT01289964
The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain
A study testing Dry Cupping or fire cupping in people with Neck Pain and Neck Pain Musculoskeletal, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Neck Pain Musculoskeletal, Mechanical/Motor Problems With Neck and Trunk
- What is being tested?
- Dry Cupping or fire cupping
- 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
- Jul 2009to Dec 2009
- 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)
- having been in treatment to an orthopaedic or to a neurologist
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 Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain
The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.
Read the detailed description
see above
- Being tested
- Dry Cupping or fire cupping
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Cupping or fire cuppingProcedure or surgery
Also called Cupping is: heating glas cups to create a vacuum on the skin
5 dry cupping treatments, application twice a week, non standardised procedure
| 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 |
| Treatment group | Active comparator | Received the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points Receives: Procedure: Dry Cupping or fire cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
100mm Visual Analogue Scale
Measured: at T2 (Day 25)
Secondary outcomes (9)
pain related to movement
100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)
Measured: at T2 (Day 25)
pain diary
Daily rating of pain intensity (numeric rating scale from 0-10)
Measured: from T0 (Day 0) to T2 (Day25)
Neck disability index
NDI measures neck pain complaints (Vernon und Mior 1991)
Measured: at T2 (Day 25)
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: at T2 (Day 25)
mechanical detection threshold MDT
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
Measured: at T2 (Day 25)
vibration detection threshold VDT
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
Measured: at T2 (Day 25)
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: at T2 (Day 25)
Side effects
open question on any side effects or other experiences with the treatment
Measured: from T1 (Day 7) to T2 (Day 25)
Medication diary
patient report used medication during the study period (amount, dose)
Measured: From T0 (Day 0) to T2 (Day 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
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 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
- Investigators
- Gustav J Dobos, Prof. MD, Principal investigator, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289964
- Sponsor's protocol ID
- DryCupping2009
- Acronym
- TS
- Status last verified
- Jul 2009
- First submitted
- 31 Jan 2011
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauche R, Cramer H, Choi KE, Rampp T, Saha FJ, Dobos GJ, Musial F. The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study. BMC Complement Altern Med. 2011 Aug 15;11:63. doi: 10.1186/1472-6882-11-63.
PubMed 21843336
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain
- ClinicalTrials.gov ID
- NCT01289964
- Acronym / sponsor ID
- TS / DryCupping2009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Feb 2011 (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 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.
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 |
| Treatment group | Active comparator | Procedure: Dry Cupping or fire cuppingReceived the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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)
- having been in treatment to an orthopaedic or to a neurologist
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 |
|---|---|---|
| Dry Cupping or fire cuppingAlso: Cupping is: heating glas cups to create a vacuum on the skin5 dry cupping treatments, application twice a week, non standardised procedure | Procedure or surgery | Treatment group |
Primary outcome
Pain intensity
Time frame: at T2 (Day 25)
100mm Visual Analogue Scale
9 secondary outcomes
pain related to movement
Time frame: at T2 (Day 25)
pain diary
Time frame: from T0 (Day 0) to T2 (Day25)
Neck disability index
Time frame: at T2 (Day 25)
Quality of Life SF-36
Time frame: at T2 (Day 25)
mechanical detection threshold MDT
Time frame: at T2 (Day 25)
vibration detection threshold VDT
Time frame: at T2 (Day 25)
pressure pain threshold PPT
Time frame: at T2 (Day 25)
Side effects
Time frame: from T1 (Day 7) to T2 (Day 25)
Medication diary
Time frame: From T0 (Day 0) to T2 (Day 25)
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 19 Aug 2011.
- Results publication: PubMed 21843336Lauche R, Cramer H, Choi KE, Rampp T, Saha FJ, Dobos GJ, Musial F. The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study. BMC Complement Altern Med. 2011 Aug 15;11:63. doi: 10.1186/1472-6882-11-63.
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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 J 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 Dry Cupping or fire cupping in people with Neck Pain and Neck Pain Musculoskeletal, 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 4 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 19 Aug 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?
Pain intensity (time frame: at T2 (Day 25)). 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 NCT01289964, 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 19 Aug 2011.