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

Not Applicable

Completed

• Conditions: Chronic Shoulder Pain
• Interventions: Procedure: Mesotherapy; Procedure: Intra-articular steroid injection

• Registration Number: NCT06610032
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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.

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 Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-08-26
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-10
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesotherapy	Mesotherapy	A total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart.
Steroid	Intra-articular steroid injection	A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Health Science University Haydarpasa Numune Research and Training Hospital; 🇹🇷 Istanbul, Üsküdar, Turkey