Clinical trial NCT06610032: The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain
Official title: The Comparison O the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients with Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Shoulder Pain
Keywords: Shoulder
Mesotherapy
Pain
Steroid Injection
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 18-75
2. Having shoulder pain for 6 months
3. VAS (Visual Analog Scale) \&gt; 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

Primary outcomes:
measure: VAS (Visual Analouge Scale)
timeFrame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
measure: Shoulder Disability Questionnaire' (OSS) form
timeFrame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
measure: Goniometric shoulder range of motion
timeFrame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Science University Haydarpasa Numune Research and Training Hospital
state: Üsküdar
Study officials:
References:
citation: 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.
citation: 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.