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

NCT06610032 | Completed

• 1 other identifier: IMU-GETAT-EK 05/27.03.2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Shoulder Pain

Keywords

Shoulder; Mesotherapy; Pain; Steroid Injection

Outcome Measures

Primary Outcomes (3)

• VAS (Visual Analouge Scale)

  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

  Functional Disability evaluation (0-100)

  Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

• Goniometric shoulder range of motion

  shoulder range of motion evaluation

  Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

Study Arms (2)

Mesotherapy

ACTIVE COMPARATOR

A total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart.

Procedure: Mesotherapy

Steroid

ACTIVE COMPARATOR

A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered.

Procedure: Intra-articular steroid injection

Interventions

Mesotherapy PROCEDURE

A total of 3 sessions of mesotherapy will be applied to the shoulder area of the patients, 7 days apart in group 1.

Also known as: Intra-articular steroid injection

Mesotherapy

Intra-articular steroid injection PROCEDURE

Single session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2.

Also known as: Mesotherapy

Steroid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

Related Publications (2)

• Mammucari M, Gatti A, Maggiori S, Sabato AF. Role of mesotherapy in musculoskeletal pain: opinions from the italian society of mesotherapy. Evid Based Complement Alternat Med. 2012;2012:436959. doi: 10.1155/2012/436959. Epub 2012 May 13.

  PMID: 22654954 BACKGROUND

• Faetani L, Ghizzoni D, Ammendolia A, Costantino C. Safety and efficacy of mesotherapy in musculoskeletal disorders: A systematic review of randomized controlled trials with meta-analysis. J Rehabil Med. 2021 Apr 27;53(4):jrm00182. doi: 10.2340/16501977-2817.

  PMID: 33764479 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Mesotherapy; Steroids

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Fused-Ring Compounds; Polycyclic Compounds

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: Medical Doctor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 24, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 10, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

TU (1)