The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain (Mesotherapy)

December 13, 2024 updated by: Ecem Pelin Kaymaz, Haydarpasa Numune Training and Research Hospital

The Comparison O the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients with Chronic Shoulder Pain

Patients with chronic shoulder pain will be divided randomly into mesotherapy and intra-articular steroid injection groups. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include 84 patients aged 18-75 who applied to physical medicine and rehabilitation out-patient clinic with chronic shoulder pain between May and July 2024. Patients will be randomly divided into two groups: a mesotherapy group and steroid injection group, using the closed-envelope method. In the first group, a total of 3 sessions of mesotherapy are applied to the shoulder areas of the patients, 7 days apart. A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered for patients in group 2. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34668
        • Health Science University Haydarpaşa Numune Research and Training Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages 18-75
  2. Having shoulder pain for 6 months
  3. VAS (Visual Analog Scale) > 4
  4. Patients who can receive verbal instructions and do not have cognitive deficits

Exclusion Criteria:

  1. Physical therapy applied to the shoulder area in the last 3 months
  2. Having had a shoulder joint injection in the last 3 months
  3. History of previous upper extremity surgery
  4. History of drug allergy
  5. Use of anticoagulant drugs (warfarin, low molecular weight heparin), patients with coagulation disorder
  6. History of malignancy
  7. Psychiatric illness
  8. A rheumatological diagnosis such as Polymyalgia Rheumatica, Rheumatoid Arthritis, Ankylosing Spondylitis
  9. Kidney failure
  10. Liver disease
  11. Heart failure
  12. Pregnancy
  13. Presence of infection, wound, allergy, burn-like lesions in the application area

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
Intervention / Treatment
Active Comparator: Mesotherapy
A total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart.
Procedure: Mesotherapy
A total of 3 sessions of mesotherapy will be applied to the shoulder area of the patients, 7 days apart in group 1.
Other Names:
  • Intra-articular steroid injection
Active Comparator: Steroid
A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered.
Procedure: Intra-articular steroid injection
Single session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2.
Other Names:
  • Mesotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goniometric shoulder range of motion
Time Frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
shoulder range of motion evaluation
Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
VAS (Visual Analouge Scale)
Time Frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Pain Severity evaluation ((0 (no pain)-10 (unbearable pain))
Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Shoulder Disability Questionnaire' (OSS) form
Time Frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Functional Disability evaluation (0-100)
Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

Collaborators and Investigators

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

Sponsor

Haydarpasa Numune Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMU-GETAT-EK 05/27.03.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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