Chronic Shoulder PainMesotherapyNCT06610032
The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain
A study testing Mesotherapy and Intra-articular steroid injection in people with Chronic Shoulder Pain, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Mesotherapy and Intra-articular steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Haydarpasa Numune Research and Training Hospital
Istanbul, Üsküdar, 34668
About this study
Official title: The Comparison o the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients With Chronic Shoulder Pain
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.
Read the 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.
- Conditions
- Chronic Shoulder Pain
- Being tested
- Mesotherapy, Intra-articular steroid injection
- Keywords
- Shoulder, Mesotherapy, Pain, Steroid Injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesotherapyProcedure or surgery
Also called 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 injectionProcedure or surgery
Also called Mesotherapy
Single session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2.
| Study group | Role | What they receive |
|---|---|---|
| Mesotherapy | Active comparator | A total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart. Receives: Procedure: Mesotherapy |
| Steroid | Active comparator | A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered. Receives: Procedure: Intra-articular steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analouge Scale)
Pain Severity evaluation ((0 (no pain)-10 (unbearable pain))
Measured: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Shoulder Disability Questionnaire' (OSS) form
Functional Disability evaluation (0-100)
Measured: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Goniometric shoulder range of motion
shoulder range of motion evaluation
Measured: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Pelin Kaymaz, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610032
- Sponsor's protocol ID
- IMU-GETAT-EK 05/27.03.2024
- Acronym
- Mesotherapy
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22654954Faetani 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.
PubMed 33764479
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison o the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients With Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT06610032
- Acronym / sponsor ID
- Mesotherapy / IMU-GETAT-EK 05/27.03.2024
- Conditions
- Chronic Shoulder Pain
- Keywords
- Shoulder, Mesotherapy, Pain, Steroid Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesotherapy | Active comparator | Procedure: MesotherapyA total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart. |
| Steroid | Active comparator | Procedure: Intra-articular steroid injectionA single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesotherapyAlso: Intra-articular steroid injectionA total of 3 sessions of mesotherapy will be applied to the shoulder area of the patients, 7 days apart in group 1. | Procedure or surgery | Mesotherapy |
| Intra-articular steroid injectionAlso: MesotherapySingle session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2. | Procedure or surgery | Steroid |
Primary outcome
VAS (Visual Analouge Scale)
Time frame: 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
Time frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
Functional Disability evaluation (0-100)
Goniometric shoulder range of motion
Time frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.
shoulder range of motion evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 22654954Mammucari 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.
- Results publication: PubMed 33764479Faetani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesotherapy and Intra-articular steroid injection in people with Chronic Shoulder Pain, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analouge Scale) (time frame: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.