Dry Cupping Therapy on Rotator Cuff Injuries

December 10, 2024 updated by: Sümeyye TUNÇ, Istanbul Medipol University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
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.
Other: Dry Cupping Therapy
Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Esra ATILGAN, Medipol University
  • Principal Investigator: Hatice Hümeyra AKIL, Uskudar University
  • Study Chair: Sümeyye TUNÇ, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

Studies a U.S. FDA-regulated device product

No

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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