- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Erzurum, Turcja (Türkiye), 25240
- Ataturk University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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.
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Aktywny komparator: Dry needling arm
Participants in this arm received three sessions of dry needling, administered once per week.
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual analog scale
Ramy czasowe: From enrollment to the end of the first month
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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
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Trigger points count
Ramy czasowe: From enrollment to the end of the first month
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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
Ramy czasowe: From enrollment to the end of the first month
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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
Ramy czasowe: From enrollment to the end of the first month
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual analog scale
Ramy czasowe: 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.
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From enrollment to the end of the third month
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Trigger points count
Ramy czasowe: From enrollment to the end of the third month
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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
Ramy czasowe: 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
Ramy czasowe: 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.
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From enrollment to the end of the third month
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Fatih Baygutalp, Medical doctor, Department of Physical Medicine and Rehabilitation, Ataturk University Faculty of Medicine
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B.30.2.ATA.0.01.00/286
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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