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

NCT06610032 — Not applicable, Completed, 84 participants, Haydarpasa Numune Training and Research Hospital

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

RegistryNCT06610032, acronym Mesotherapy
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment84 (Actual)
SponsorHaydarpasa Numune Training and Research Hospital (Other)
ConditionsChronic Shoulder Pain
InterventionsMesotherapy, Intra-articular steroid injection (Procedure)
Datesstart 2024-07-01, primary completion 2024-09-01, completion 2024-09-10, first posted 2024-09-24, last updated 2024-12-18
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Shoulder Pain All trials of Mesotherapy All trials of Intra-articular steroid injection

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
MesotherapyActive comparatorProcedure: MesotherapyA total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart.
SteroidActive comparatorProcedure: Intra-articular steroid injectionA single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered.
  • Mesotherapy (Procedure), also known as Intra-articular steroid injection: A total of 3 sessions of mesotherapy will be applied to the shoulder area of the patients, 7 days apart in group 1.
  • Intra-articular steroid injection (Procedure), also known as Mesotherapy: Single session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2.

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

FacilityCityCountryStatus
Health Science University Haydarpasa Numune Research and Training HospitalIstanbul, ÜsküdarTurkey (Türkiye)

+Publications

  • Results publication: 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
  • Results publication: 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