- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975801
Dry Cupping Therapy on Rotator Cuff Injuries
Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries
Study Overview
Status
Detailed Description
Shoulder pain is the most common musculoskeletal problem after spine and knee complaints. Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and total ruptures of the rotator cuff. Conservative and surgical techniques are used in the treatment. Conservative treatments; various medical treatments, activity modifications, hot and cold agents, exercise, manual therapy, acupuncture, electrophysical agents, etc. includes applications. In recent years there has been a renewed interest in traditional and complementary medicine (TCM) for various musculoskeletal problems. Cupping therapy is an ancient TCM treatment that has been practiced in different ways in many cultures in Asia, Europe and the Middle East throughout history, but its true origin remains unclear. Although cupping therapy has been used to treat pain and various complaints for thousands of years, it has almost disappeared from the therapeutic spectrum of Western medicine with pharmacological developments in the late 20th century. However, over the past few years, interest in the cup has increased, and new clinical research suggests that the cup may be potentially effective in the management of painful conditions, in the treatment of pain-related diseases. Although it is stated in the literature that it is used in the treatment of many neuromusculoskeletal problems, according to the information participants have obtained in the relevant literature, there is not yet a study examining the effects of cupping therapy in RCI. In the light of these data, our aim in this study is to investigate the effects of moving dry cupping therapy on pain, range of motion (ROM), functionality and quality of life in RCI.Hypotheses:
H0: Cupping therapy has no effect on improving pain, ROM, functionality and quality of life in individuals with RCI.
H1: Cupping therapy has an effect on improving pain, ROM, functionality and quality of life in individuals with RCI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 25-70 age range
- Clinical diagnosis ofRCI, SIS, supraspinatus tendinitis
- To be fully cooperative
Exclusion Criteria:
- Patients who had undergone any surgical operation on the shoulder
- A history of shoulder fracture
- Severe osteoporosis
- Total tendon rupture
- Had received oral/intramuscular steroids in the last 1 month
- Had been administered intra-articular drugs in the last 3 months
- Difficulty in cooperation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Conservative Treatment Group
The patients in the control group received a conservative treatment program including hotpack (20 min), transcutaneous electrical nerve stimulation(TENS) (COMPEX Rehab 400 - 20 min), ultrasound (Chattanooga Ultrasound - 1 megahertz, 1.5 W/cm², 5 min) for 4 weeks, 5 days a week, and wand, Codman, stretching and strengthening exercises were applied.Stretching exercises were added to the treatment for the shoulder girdle and scapular region muscles, while strengthening exercises were added to the treatment by increasing the resistance at the pain limit.
In addition, the home exercise program was taught to be 10 repetitions 2 times a day.
|
|
|
Active Comparator: Dry Cupping Therapy Group
In addition to the conventional treatment, moving cup application was applied for 10 minutes twice a week.
During the treatment, the patients were placed in a side-lying position with the affected side on top.
Liquid petroleum jelly was applied on the skin and negative pressure was created with a manual pump, allowing the cup to be slid on the skin.
Care was taken to ensure that the negative pressure would not cause increased pain and would allow the cup to slide.
Deltoid, Trapeze, Supraspinatus, Infraspinatus, Pectoral muscles were applied in the origo insertion direction for a total of 10 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: 1 months
|
Shoulder flexion, abduction, internal and external rotation in the supine position using a baseline goniometer; Shoulder extension ROM in the prone position was evaluated as passive.
|
1 months
|
|
Constant-Murley Score
Time Frame: 1 months
|
Developed in 1987, this scoring system evaluates pain, activities of daily living, strength, and ROM.
Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.
In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points
|
1 months
|
|
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: 1 months
|
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
|
1 months
|
|
Short Form (SF-36)
Time Frame: 1 months
|
SF-36, which is one of the most preferred scales in assessing the quality of life, consists of a total of 36 questions and 8 sections.
It is divided into 8 parts as physical function, social function, physical role difficulty, emotional role difficulty, mental health, energy/vitality, pain and general health perception.
Each section is scored between 0-100 in itself.
High scores indicate high quality of life.
|
1 months
|
|
Shoulder Pain
Time Frame: 1 months
|
Pain was evaluated with the Numerical Rating Scale (NRS).
The patient was asked to mark his pain in numerical values ranging from 0 (no pain) to 10 (very severe pain).
The higher the score obtained from this test, the more pain the patient has, and the smaller the score, the less the pain is predicted.
|
1 months
|
Collaborators and Investigators
Investigators
- Study Director: Esra ATILGAN, Medipol University
- Principal Investigator: Hatice Hümeyra AKIL, Uskudar University
- Study Chair: Sümeyye TUNÇ, Medipol University
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 (Estimated)
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
- IMU-FTR-ST-02
- Medipol University (Registry Identifier: 10840098-604.01.01-E.10470)
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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