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

NCT ID: NCT06610032

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-09-10

Brief Summary

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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

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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.

Conditions

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Chronic Shoulder Pain

Keywords

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Shoulder Mesotherapy Pain Steroid Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mesotherapy

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

Group Type ACTIVE_COMPARATOR

Mesotherapy

Intervention Type PROCEDURE

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

Steroid

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

Group Type ACTIVE_COMPARATOR

Intra-articular steroid injection

Intervention Type PROCEDURE

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

Interventions

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Mesotherapy

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

Intervention Type PROCEDURE

Intra-articular steroid injection

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

Intervention Type PROCEDURE

Other Intervention Names

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Intra-articular steroid injection Mesotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ecem Pelin Kaymaz

Medical Doctor of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22654954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33764479 (View on PubMed)

Other Identifiers

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IMU-GETAT-EK 05/27.03.2024

Identifier Type: -

Identifier Source: org_study_id