Trigger Point Pain, MyofascialNCT05123105
Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
A study testing 1) cupping therapy and 3) ischemic compression in people with Trigger Point Pain, Myofascial, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- 1) cupping therapy and 3) ischemic compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 23 Jan 2021to 30 Mar 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-30
- student of The Józef Piłsudski University of Physical Education in Warsaw
- written consent to participate in the study
Who cannot join
- past or current injury to the trapezius.
- past or current injury of the cervical spine limiting mobility of this segment.
- broken skin at the examination site.
- cardiological disease and use of blood pressure medication, histamine medication and analgesics
- elevated body temperature, illness symptoms and a period of convalescence.
- a missed anti-Covid procedure before each examination.
- inability to find trigger points.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Józef Piłsudski University of Physical Education in Warsaw
Warsaw, Masovian Voivodeship, 00-968
About this study
Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located.
The aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- 1) cupping therapy, 2) control test (no intervention), 3) ischemic compression
- Keywords
- ischemic compression, cupping, algometer, trapezius muscle
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) cupping therapyOther
The participant lay on his front on a couch. The examiner applied a plastic cup on a pre-marked trigger point, suctioned it with a mechanical pump and left it for 2 minutes. This was a stationary application with medium suction force. Therapy was performed on both sides. Measurements were taken before and 2 minutes after the therapy.
2) control test (no intervention)Other
The participant lay on his front on a couch for 4 minutes without any activity and without anyy intervention. Measurements were taken before and after the session.
3) ischemic compressionOther
The participant lay on his front on a couch. The researcher applied pressure to a pre-marked trigger point using the thumb for 2 minutes until tissue resistance was felt. This included 60-second compression and after a break of a few seconds, another 60 seconds of compression. Therapies were performed on each side. Measurements were taken before and 2 minutes after the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Each person participated in three tests with an interval of approximately one week between them. Receives: Other: 1) cupping therapy; Other: 2) control test (no intervention); Other: 3) ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold test (PPT)
The trigger points of the upper section of the trapezius on the right and left sides were determined by palpation and were also indicated using a marker. A Wagner FDX 50 Force Gage algometer was applied to the trigger point. The pressure force was increased by 1kg/cm2/s until the patient felt pain, which was the pain pressure threshold (PPT) measured in kg/cm2. The test was performed on both sides. The test was performed twice on each side - before and 2 minutes after the session.
Measured: changes from baseline in pain pressure threshold at 2 minutes after the session
Cervical spine mobility test
Each examination began in a sitting position with a cervical spine mobility test. The following bone points were marked on the participants' skin using a marker: spinous process of the 7th cervical vertebra, external occipital protuberance, the top of the chin, the jugular notch of the sternum, the mastoid of the temporal bone, and the acromion process of the scapula. Next, a linear measurement of the range of motion was performed using a tape measure to ascertain the distance between the marked points in the initial position and after the active movement for flexion (forward bending), extension (backward bending), lateral bending and rotation to both sides, respectively. The mobility was determined by the difference of the two measurements. The test for each movement (i.e. flexion (forward flexion), extension (backward flexion), lateral flexion and both sides rotation) was performed twice - before and 2 minutes after the session.
Measured: changes from baseline in cervical spine mobility at 2 minutes after the session
Secondary outcomes (2)
Height
Height measured in meters
Measured: Measurements were taken before the first session
Weight
Weight measured in kilograms
Measured: Measurements were taken before the first session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start23 Jan 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version) 1. cupping therapy; \- a minimum interval of 7 days; 2. control test; \- a minimum interval 7 days; 3. ischemic compression.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Zdrodowska, Józef Piłsudski University of Physical Education
- Investigators
- Agnieszka Zdrodowska, PH.D, Principal investigator, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123105
- Sponsor's protocol ID
- SKE 01-03/2021
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
- ClinicalTrials.gov ID
- NCT05123105
- Acronym / sponsor ID
- SKE 01-03/2021
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- ischemic compression, cupping, algometer, trapezius muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- 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.
Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located.
The aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version) 1. cupping therapy; - a minimum interval of 7 days; 2. control test; - a minimum interval 7 days; 3. ischemic compression.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: 1) cupping therapy, Other: 2) control test (no intervention), Other: 3) ischemic compressionEach person participated in three tests with an interval of approximately one week between them. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-30
- student of The Józef Piłsudski University of Physical Education in Warsaw
- written consent to participate in the study
Key exclusion criteria (7 listed)
- past or current injury to the trapezius.
- past or current injury of the cervical spine limiting mobility of this segment.
- broken skin at the examination site.
- cardiological disease and use of blood pressure medication, histamine medication and analgesics
- elevated body temperature, illness symptoms and a period of convalescence.
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 |
|---|---|---|
| 1) cupping therapyThe participant lay on his front on a couch. The examiner applied a plastic cup on a pre-marked trigger point, suctioned it with a mechanical pump and left it for 2 minutes. This was a stationary application with medium suction force. Therapy was performed on both sides. Measurements were taken before and 2 minutes after the therapy. | Other | Experimental |
| 2) control test (no intervention)The participant lay on his front on a couch for 4 minutes without any activity and without anyy intervention. Measurements were taken before and after the session. | Other | Experimental |
| 3) ischemic compressionThe participant lay on his front on a couch. The researcher applied pressure to a pre-marked trigger point using the thumb for 2 minutes until tissue resistance was felt. This included 60-second compression and after a break of a few seconds, another 60 seconds of compression. Therapies were performed on each side. Measurements were taken before and 2 minutes after the therapy. | Other | Experimental |
Primary outcome
Pain pressure threshold test (PPT)
Time frame: changes from baseline in pain pressure threshold at 2 minutes after the session
The trigger points of the upper section of the trapezius on the right and left sides were determined by palpation and were also indicated using a marker. A Wagner FDX 50 Force Gage algometer was applied to the trigger point. The pressure force was increased by 1kg/cm2/s until the patient felt pain, which was the pain pressure threshold (PPT) measured in kg/cm2. The test was performed on both sides. The test was performed twice on each side - before and 2 minutes after the session.
Cervical spine mobility test
Time frame: changes from baseline in cervical spine mobility at 2 minutes after the session
Each examination began in a sitting position with a cervical spine mobility test. The following bone points were marked on the participants' skin using a marker: spinous process of the 7th cervical vertebra, external occipital protuberance, the top of the chin, the jugular notch of the sternum, the mastoid of the temporal bone, and the acromion process of the scapula. Next, a linear measurement of the range of motion was performed using a tape measure to ascertain the distance between the marked points in the initial position and after the active movement for flexion (forward bending), extension (backward bending), lateral bending and rotation to both sides, respectively. The mobility was determined by the difference of the two measurements. The test for each movement (i.e. flexion (forward flexion), extension (backward flexion), lateral flexion and both sides rotation) was performed twice - before and 2 minutes after the session.
2 secondary outcomes
Height
Time frame: Measurements were taken before the first session
Weight
Time frame: Measurements were taken before the first session
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 17 Nov 2021.
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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.
Agnieszka Zdrodowska, PH.D principal investigator
Józef Piłsudski University of Physical Education in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1) cupping therapy and 3) ischemic compression in people with Trigger Point Pain, Myofascial, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 7 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 17 Nov 2021. 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 Poland. 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 pressure threshold test (PPT) (time frame: changes from baseline in pain pressure threshold at 2 minutes after the session). The study lists 2 primary outcomes in all. 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 17 Nov 2021.