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Dry Cupping Therapy on Rotator Cuff Injuries

Primary Purpose

Rotator Cuff Injuries, Shoulder Pain, Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry Cupping Therapy
Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Complementary Therapies, Cupping Therapy, Range of Motion, Rotator Cuff Injuries, Shoulder Pain, Quality of Life

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Dry Cupping Therapy Group

    Conservative Treatment Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Shoulder pain
    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.
    Range of Motion
    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.
    Constant-Murley Score
    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
    The Disabilities of the Arm, Shoulder and Hand (DASH)
    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
    Short Form (SF-36)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Istanbul Medipol University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05975801
    Brief Title
    Dry Cupping Therapy on Rotator Cuff Injuries
    Official Title
    Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medipol University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Injuries, Shoulder Pain, Subacromial Impingement Syndrome
    Keywords
    Complementary Therapies, Cupping Therapy, Range of Motion, Rotator Cuff Injuries, Shoulder Pain, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dry Cupping Therapy Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conservative Treatment Group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Dry Cupping Therapy
    Intervention Type
    Other
    Intervention Name(s)
    Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
    Primary Outcome Measure Information:
    Title
    Shoulder pain
    Description
    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.
    Time Frame
    1 months
    Title
    Range of Motion
    Description
    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.
    Time Frame
    1 months
    Title
    Constant-Murley Score
    Description
    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
    Time Frame
    1 months
    Title
    The Disabilities of the Arm, Shoulder and Hand (DASH)
    Description
    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
    Time Frame
    1 months
    Title
    Short Form (SF-36)
    Description
    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.
    Time Frame
    1 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esra ATILGAN
    Organizational Affiliation
    Medipol University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hatice Hümeyra AKIL
    Organizational Affiliation
    Uskudar University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sümeyye TUNÇ
    Organizational Affiliation
    Medipol University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Dry Cupping Therapy on Rotator Cuff Injuries

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