NCT05933382

Brief Summary

Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the most frequently encountered musculoskeletal issues within the community. Rotator cuff tears are a crucial pathophysiological contributor to shoulder pain. Individuals afflicted with this condition frequently report nocturnal intensification of pain and movement-specific aggravation, especially during overhead activities. The condition is frequently correlated with functional impairment, with many patients noting a sensation of weakness. Conservative treatment of the rotator cuff tear consists of a wide range of procedures such as exercise therapy; and/or local anesthetic, ice/heat therapy, electrotherapy, various types of manual therapy and joint mobilization procedures. Corticosteroid injection approach is an alternative method to these applications The subacromial corticosteroid injection is an intervention technique that has been utilized for short-term relief over numerous years.Given the restricted self-repair capabilities of tendons the consideration of novel biological treatment strategies for tendinopathies has gained prominence in recent times. Nonetheless, there remains a lack of sufficient scientific evidence to substantiate their efficacy.Mulligan mobilization techniques are manual therapy techniques that aim to increase normal joint movement and reduce pain levels by correcting the biomechanical structure of joint surfaces to provide a pain-free range of motion. A review of the literature reveals no studies comparing the Mulligan mobilization technique and corticosteroid injections in rotator cuff tears. The aim of our study is to examine the effects of the Mulligan mobilization technique and corticosteroid injections on pain, range of motion, functionality and proprioception in individuals with rotator cuff tears.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

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

First Submitted

Initial submission to the registry

June 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

June 12, 2023

Last Update Submit

February 19, 2024

Conditions

Keywords

Mobilization with movementRotator cuffCorticosteroid

Outcome Measures

Primary Outcomes (2)

  • Visuel Analogue Scale (VAS)

    The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    5 minutes

  • Normal range of motion and proprioception

    Normal range of motion and proprioception can be measured with Becure Extremity ROM

    10 minutes

Secondary Outcomes (1)

  • Functionality

    5 minutes

Study Arms (2)

Corticosteroid Group

EXPERIMENTAL

A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid injection will be administered to the shoulder region of the first group prior to treatment.

Other: Corticosteroid Group

Mulligan Group

EXPERIMENTAL

A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). In addition to the conventional treatment program, a mobilization technique with movement will be applied twice a week, with 10 repetitions.

Other: Mulligan Group

Interventions

Conventional exercise and corticosteroid injection

Corticosteroid Group

Conventional exercise and mulligan mobilization

Mulligan Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 40 and 60
  • Not having had any shoulder surgery before
  • Having been diagnosed with a rotator cuff lesion
  • Not having any orthopedic or cardiac problems that could hinder participation in the study and evaluation

You may not qualify if:

  • Having a pathology affecting the shoulder area
  • Having had any shoulder surgery
  • Individuals who are non-cooperative or have mental problems
  • Individuals with neurological, cardiac, and vascular problems
  • Individuals who have participated in any physiotherapy program directed towards the shoulder in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

Related Publications (1)

  • Menek B, Menek MY. The efficacy of Mulligan mobilization and corticosteroid injection on pain, functionality, and proprioception in rotator cuff tears: A randomized controlled trial. J Hand Ther. 2025 Jul-Sep;38(3):410-417. doi: 10.1016/j.jht.2024.12.016. Epub 2025 Feb 6.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Merve YILMAZ MENEK, PhD

    Medipol 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
Principal Investigator

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 6, 2023

Study Start

July 1, 2023

Primary Completion

September 6, 2023

Study Completion

February 10, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations