Dry Cupping Therapy on Rotator Cuff Injuries

• ClinicalTrials.gov Identifier: NCT05975801
• Recruitment Status: Completed
• First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): sumeyye tunc, Istanbul Medipol University Hospital

Study Description

Brief Summary:

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. In recent years there has been a renewed interest in traditional and complementary medicine (TCM) for various musculoskeletal problems. Cupping therapy, which is one of the most commonly used TCM methods, is one of the oldest medical applications with thousands of years of history. Although it is thought to be effective in many diseases, there are not enough studies in the literature about its effectiveness and mechanism of action. 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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Injuries; Shoulder Pain; Subacromial Impingement Syndrome	Other: Dry Cupping Therapy; Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Dry Cupping Therapy
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.	Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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
4. 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
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Istanbul Medipol University Hospital

Investigators

• Study Director: Esra ATILGAN; Medipol University
• Principal Investigator: Hatice Hümeyra AKIL; Uskudar University
• Study Chair: Sümeyye TUNÇ; Medipol University

More Information

• Responsible Party: sumeyye tunc, PhD, PT, Asist. Prof., Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT05975801
• Other Study ID Numbers: Medipol University Hospital; Medipol University ( Registry Identifier: 10840098-604.01.01-E.10470 )
• First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by sumeyye tunc, Istanbul Medipol University Hospital:

Complementary Therapies; Cupping Therapy; Range of Motion; Rotator Cuff Injuries; Shoulder Pain; Quality of Life

Additional relevant MeSH terms:

Shoulder Pain; Shoulder Impingement Syndrome; Wounds and Injuries; Rotator Cuff Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Shoulder Injuries; Rupture; Tendon Injuries