- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Erzurum, Турция (Туркие), 25240
- Ataturk University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Visual analog scale
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Visual analog scale
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Директор по исследованиям: Fatih Baygutalp, Medical doctor, Department of Physical Medicine and Rehabilitation, Ataturk University Faculty of Medicine
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- B.30.2.ATA.0.01.00/286
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Изучает лекарственный продукт, регулируемый FDA США.
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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