Rotator Cuff InjuriesNCT05975801
Dry Cupping Therapy on Rotator Cuff Injuries
A study testing Dry Cupping Therapy and Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound in people with Rotator Cuff Injuries and Shoulder Pain, run by Istanbul Medipol University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Pain, Subacromial Impingement Syndrome
- What is being tested?
- Dry Cupping Therapy and Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-70 age range
- Clinical diagnosis ofRCI, SIS, supraspinatus tendinitis
- To be fully cooperative
Who cannot join
- 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
About this study
Official title: Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries
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.
Read the 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.
- Being tested
- Dry Cupping Therapy, Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
- Keywords
- Complementary Therapies, Cupping Therapy, Range of Motion, Rotator Cuff Injuries, Shoulder Pain, Quality of Life
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Cupping TherapyOther
Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| Dry Cupping Therapy Group | Active comparator | 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. Receives: Other: Dry Cupping Therapy; Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound |
| Conservative Treatment Group | Other | 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. Receives: Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
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.
Measured: 1 months
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
Measured: 1 months
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
Measured: 1 months
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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study startJan 2017
- Primary completionMay 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sumeyye tunc, Istanbul Medipol University Hospital
- Investigators
- Esra ATILGAN, Study director, Medipol UniversityHatice Hümeyra AKIL, Principal investigator, Uskudar UniversitySümeyye TUNÇ, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975801
- Sponsor's protocol ID
- IMU-FTR-ST-02
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries
- ClinicalTrials.gov ID
- NCT05975801
- Acronym / sponsor ID
- IMU-FTR-ST-02
- Keywords
- Complementary Therapies, Cupping Therapy, Range of Motion, Rotator Cuff Injuries, Shoulder Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Cupping Therapy Group | Active comparator | Other: Dry Cupping Therapy, Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasoundIn 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. |
| Conservative Treatment Group | Other | Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasoundThe 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-70 age range
- Clinical diagnosis ofRCI, SIS, supraspinatus tendinitis
- To be fully cooperative
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Cupping Therapy | Other | Dry Cupping Therapy Group |
| Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound | Other | Conservative Treatment Group, Dry Cupping Therapy Group |
Primary outcome
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.
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra ATILGAN study director
Medipol University
Hatice Hümeyra AKIL principal investigator
Uskudar University
Sümeyye TUNÇ study chair
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Dry Cupping Therapy and Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound in people with Rotator Cuff Injuries and Shoulder Pain, run by Istanbul Medipol University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: 1 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.