- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688317
DRY NEEDLING VS. CUPPING THERAPY IN MPS
COMPARISON OF THE EFFECTIVENESS OF DRY NEEDLING AND CUPPING THERAPY IN PATIENTS WITH MYOFASCIAL PAIN SYNDROME: A RANDOMIZED TRIAL
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study evaluated the effectiveness of dry needling (DN) and cupping therapy in 92 patients with chronic myofascial pain syndrome. Participants were randomly divided into two groups: one receiving a 10-session cupping regimen and the other undergoing a three-session dry needling protocol, with both groups performing home-based exercises.
Results showed that both treatments significantly reduced pain and improved patient outcomes over three months. When compared directly, cupping therapy was more effective at reducing trigger points and improving overall quality of life. Conversely, dry needling resulted in higher levels of patient satisfaction. In conclusion, both methods are valuable tools for managing myofascial pain, and the choice of treatment may depend on whether the clinical priority is physical symptom relief or patient preference. Further research is recommended to better define the specific long-term applications of these therapies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey (Türkiye), 25240
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Back pain lasting more than three months
- At least one palpable myofascial TN in the trapezius, supraspinatus, infraspinatus, and/or levator scapulae muscles
- Written informed consent
Exclusion Criteria:
- Prior dry needling treatment
- Prior cupping therapy
- Severe cognitive dysfunction
- Spinal fracture
- Infection
- Malignancy
- Ankylosing spondylitis
- Central nervous system injury
- Psychiatric disorder
- Diseases causing tissue degeneration
- Conditions associated with spasticity or cerebrovascular disease
- Cervical radiculopathy due to structural abnormalities
- Muscle or tendon injuries of the shoulder or neck
- Fibromyalgia or other conditions presenting with symptoms similar to myofascial pain syndrome
- Use of anticoagulant or antiplatelet therapy
- Thrombocytopenia or hemorrhagic disorders
- A history of surgery or blood donation within the previous three months
- Pregnancy
- Breastfeeding
- Presence of renal, hepatic, or severe cardiovascular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cupping therapy arm
Dry cupping was conducted 3 times per week for 9 sessions, followed by one session of wet cupping at the tenth session.
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In the tenth session, wet cupping was performed directly over the patients' TNs.
In addition to the TNs, wet cupping was also applied at the Dazhui DU-14 point in all patients.
Before initiating the procedure, the treatment area was disinfected with alcohol.
Sterile single-use cups numbered 5 and 6 were applied to the treatment area.
After 3 to 5 minutes, the cups were removed one at a time.
After the area was cleaned, a No. 15 scalpel blade was used to make shallow vertical cuts at the cupping site.
Afterward, the cups were returned to the same places.
The procedure was performed three times without making any new cuts.
The blood was drained, and the cups were put back on.
The entire procedure lasted approximately 20 min.
The cups were removed at the end of the procedure, and the area that had been treated was cleaned and covered properly.
|
|
Active Comparator: Dry needling arm
Participants in this arm received three sessions of dry needling, administered once per week.
|
Needling was performed while the TNs in the levator scapulae, supraspinatus, and upper part of the trapezius muscles were sitting.
Patients were placed in the prone position for the middle and lower parts of the trapezius and infraspinatus muscles.
To increase the accuracy of localization and minimize the risk of injury to nearby structures, needling was performed under ultrasound guidance.
We used the Esaote MyLab 60 ultrasound machine that we have in our clinic for this.
Standard single-use sterile acupuncture needles (0.25 mm × 25 mm) were used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale
Time Frame: From enrollment to the end of the first month
|
The VAS score was used to measure pain intensity in each patient.
Patients were told to rate their pain on a 10-cm horizontal line for the VAS test.
A score of 0 indicated no pain, a score of 5 indicated moderate pain, and a score of 10 indicated the worst pain.
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From enrollment to the end of the first month
|
|
Trigger points count
Time Frame: From enrollment to the end of the first month
|
Trigger points were identified in the trapezius, levator scapulae, supraspinatus, and infraspinatus muscles by the presence of a hypersensitive spot within a palpable taut band, accompanied by a visible or palpable LTR and/or reproduction of referred pain upon palpation of the sensitive point.
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From enrollment to the end of the first month
|
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Multidimensional quality of life score
Time Frame: From enrollment to the end of the first month
|
The multidimensional quality of life scale includes a total of 35 items and assesses nine subdomains, each with four items.
The overall score is obtained by summing the responses to all the items.
Each item is given a score from 1 to 7, with a total score of 35 to 245.
Higher scores indicate better functional status.
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From enrollment to the end of the first month
|
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Likert satisfaction scale
Time Frame: From enrollment to the end of the first month
|
Patient satisfaction was assessed using a Likert scale, where participants were asked to rate their experience by selecting one of the following options: none, mild, moderately good, good, or very good.
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From enrollment to the end of the first month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale
Time Frame: From enrollment to the end of the third month
|
The VAS score was used to measure pain intensity in each patient.
Patients were told to rate their pain on a 10-cm horizontal line for the VAS test.
A score of 0 indicated no pain, a score of 5 indicated moderate pain, and a score of 10 indicated the worst pain.
|
From enrollment to the end of the third month
|
|
Trigger points count
Time Frame: From enrollment to the end of the third month
|
Trigger points were identified in the trapezius, levator scapulae, supraspinatus, and infraspinatus muscles by the presence of a hypersensitive spot within a palpable taut band, accompanied by a visible or palpable LTR and/or reproduction of referred pain upon palpation of the sensitive point.
|
From enrollment to the end of the third month
|
|
Multidimensional quality of life score
Time Frame: From enrollment to the end of the third month
|
The multidimensional quality of life scale includes a total of 35 items and assesses nine subdomains, each with four items.
The overall score is obtained by summing the responses to all the items.
Each item is given a score from 1 to 7, with a total score of 35 to 245.
Higher scores indicate better functional status.
|
From enrollment to the end of the third month
|
|
Likert satisfaction scale
Time Frame: From enrollment to the end of the third month
|
Patient satisfaction was assessed using a Likert scale, where participants were asked to rate their experience by selecting one of the following options: none, mild, moderately good, good, or very good.
|
From enrollment to the end of the third month
|
Collaborators and Investigators
Investigators
- Study Director: Fatih Baygutalp, Medical doctor, Department of Physical Medicine and Rehabilitation, Ataturk University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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