NCT06535750

Brief Summary

Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Physiotherapy methods include various interventions such as manual therapy, exercise, and electrotherapy. Although these treatments do not directly treat the specific pathology, they help correct rotator cuff and scapular muscle weakness and dysfunction, reduce the tightness of the posterior capsule and other soft tissues, and relieve pain and dysfunction. It focuses on correcting the postural abnormalities that contribute to the disease. In our study, the investigators aimed to determine the effects of rehabilitation components in the conservative treatment of patients with rotator cuff syndrome and to determine the effects of strengthening exercises on the functional status of the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 23, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Rotator CuffExercisePain

Outcome Measures

Primary Outcomes (1)

  • Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH):

    Quick DASH was used as the primary outcome measure because it is a questionnaire that assesses upper extremity injuries and symptoms and measures their impact on patients' activities of daily living. Each section of the Quick-DASH questionnaire yields a score between 0 and 100 (0= no disability, 100= maximum disability).10,11

    3 months

Secondary Outcomes (2)

  • Western Ontario Rotator Cuff Index (WORC)

    1 months

  • Nothingam Health Profile (NSP):

    1 months

Study Arms (2)

Rotator Cuff Patients with used to conventional rehabilitation

EXPERIMENTAL

Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient.

Other: Exercise

Rotator Cuff Patients with used to conventional rehabilitation add to strenght exercise.

EXPERIMENTAL

Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient.

Other: Exercise

Interventions

Participants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below.

Rotator Cuff Patients with used to conventional rehabilitationRotator Cuff Patients with used to conventional rehabilitation add to strenght exercise.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having complaints for at least three months
  • having positive Empty can test
  • having rotator cuff injury
  • having loss of function in the shoulder and volunteering to participate in the study

You may not qualify if:

  • cardiovascular disease that would interfere with the rehabilitation process,
  • who had neurological or systemic musculoskeletal disease
  • who had undergone upper extremity surgery
  • who had upper extremity scapula fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy and Rehabilitation Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (2)

  • Gomoll AH, Katz JN, Warner JJ, Millett PJ. Rotator cuff disorders: recognition and management among patients with shoulder pain. Arthritis Rheum. 2004 Dec;50(12):3751-61. doi: 10.1002/art.20668. No abstract available.

    PMID: 15593187BACKGROUND
  • Galetta MD, Keller RE, Sabbag OD, Linderman SE, Fury MS, Medina G, O'Donnell EA, Cheng TTW, Harris E, Oh LS. Rehabilitation variability after rotator cuff repair. J Shoulder Elbow Surg. 2021 Jun;30(6):e322-e333. doi: 10.1016/j.jse.2020.11.016. Epub 2021 Jan 5.

    PMID: 33418088BACKGROUND

MeSH Terms

Conditions

Motor ActivityPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yasemin ŞAHBAZ

    Istanbul Beykent University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant profesor

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 2, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 22, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

It was not considered appropriate to share individual information.

Locations