NCT05975801

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

July 25, 2023

Last Update Submit

December 10, 2024

Conditions

Keywords

Complementary TherapiesCupping TherapyRange of MotionRotator Cuff InjuriesShoulder PainQuality of Life

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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

    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.

    1 months

Study Arms (2)

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.

Other: Dry Cupping TherapyOther: 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.

Other: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound

Interventions

Dry Cupping Therapy Group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age range
  • Clinical diagnosis ofRCI, SIS, supraspinatus tendinitis
  • To be fully cooperative

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder PainShoulder Impingement Syndrome

Interventions

Conservative TreatmentTranscutaneous Electric Nerve StimulationHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Esra ATILGAN

    Medipol University

    STUDY DIRECTOR
  • Hatice Hümeyra AKIL

    Uskudar University

    PRINCIPAL INVESTIGATOR
  • Sümeyye TUNÇ

    Medipol University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 4, 2023

Study Start

January 1, 2017

Primary Completion

May 1, 2017

Study Completion

January 1, 2019

Last Updated

December 13, 2024

Record last verified: 2024-12