OsteoarthritisAMG_1NCT06997991

Prospective Clinical Study to Evaluate the Safety and Efficacy of Intraarticular Administration of Micro-grafts of Adipose Tissue (Adipo-micro-grafts) in the Treatment of Osteoarthritis of the Trapezium-metacarpal Joint (ADIPO_MICRO_GRAFTS_1)

A study testing adipose micro-grafts injection in people with Osteoarthritis and Osteoarthritis Thumbs, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this interventional study is the Change in the Michigan Hand Questionnaire (MHQ) score over time in subjects with Eaton Littler grade II and III trapeziometacarpal osteoarthritis. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis, Osteoarthritis Thumbs
What is being tested?: adipose micro-grafts injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteItaly
Study dates: 26 Jul 2022to 1 Sep 2023
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed written informed consent.
Male or female aged ≥ 40 and ≤ 75 years
Normal axial alignment
Eaton/Littler stage 2-3
MHQ pain scale
Willingness to participate in all scheduled follow-ups
Willingness to abstain from taking level 2 analgesics and opioids for the duration of the study. NSAIDs and Paracetamol are permitted.

Who cannot join

Pregnant and/or breastfeeding women.
If a woman, of childbearing age and the subject is not using a highly effective method of birth control and is not willing to use it during participation in the clinical trial. Highly effective methods of birth control include: combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal); progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;
Intra-articular injection within 3 months of treatment.
Immunocompromised for reasons such as corticosteroid therapy, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
Previous hand surgery within the last 6 months
History of connective tissue disease, such as systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
Infections in the trapezium-metacarpal joint, skin disease or infections in the area of the injection site

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliera Universitaria Ospedali Riuniti
Ancona

Other trials in Italy

About this study

Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of Intraarticular Administration of Micro-grafts of Adipose Tissue (Adipo-micro-grafts) in the Treatment of Osteoarthritis of the Trapezium-metacarpal Joint

The objective of this interventional study is the Change in the Michigan Hand Questionnaire (MHQ) score over time in subjects with Eaton Littler grade II and III trapeziometacarpal osteoarthritis.

The main questions to be answered are:

primary outcomes: Differences in the change in the MHQ scale measured as a reduction in the score result of 12 points within 6 months from preoperative.
secondary outcomes: Change from baseline in hand function measured by grip strength (Gripstrength); Change from baseline in hand function by lateral grip strength (tippinch and tripodpinch); Change in the Visual Analogue Scale (VAS) pain scale before the procedure then after the procedure, at 1, 3 and 6 months; Safety and tolerance of the treatments.

Conditions: Osteoarthritis, Osteoarthritis Thumbs
Being tested: adipose micro-grafts injection
Keywords: adipose stem cells, Rigenera protocol, trapeziometacarpal arthritis, microfragmented adipose tissue
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

adipose micro-grafts injectionProcedure or surgery
Patients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe.

Study groups in NCT06997991
Study group	Role	What they receive
Adipose micro-grafts	Experimental	Patients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe. Receives: Procedure: adipose micro-grafts injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in hand and upper limb function measured by the Michigan Hand questionnaire
The Michigan Hand Questionnaire (MHQ) is a validated instrument specifically designed to assess hand function and the impact of upper extremity conditions on quality of life. The questionnaire explores six main dimensions: general function, activities of daily living (ADL), pain, aesthetics, patient satisfaction, and work function.
The score for each domain is converted to a scale of 0 to 100, where:
100 represents the best perceived functional outcome, 0 represents the worst outcome.
For some subsections (such as pain), the scale is reversed to ensure correct interpretation of the scores.
Measured: The MHQ will be administered at three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention, in order to monitor clinical progress and treatment effectiveness.

Secondary outcomes (1)

Evaluation of: 1. Change from baseline in hand function measured by grip strength 2. Change from baseline in hand function measured by lateral grip strength (tip pinch and tripod pinch) 3. Change in visual analogue scale of pain (VAS) over time 4.Safety
1. The grip strength of the treated hand is measured with the JAMAR manual hydraulic dynamometer in kilograms of pressure by taking the greatest force of three successive attempts with 15 seconds of rest between each attempt.
2. The lateral grip strength (tippinch: between the thumb and index finger; tripodpinch: between the thumb, index finger and middle finger) of the treated hand is measured with the mechanical grip meter in kilograms of pressure by taking the greatest force of three successive attempts with 15 seconds of rest between each attempt.
3. Differences in the pain scale measured as a reduction in pain perception. Pain in the treated joint will be assessed by a visual analogue scale that requires the patient to respond by placing a vertical line on a 100mm scale where 0 corresponds to "no pain" and 100 "unbearable pain".
4. Evaluation of the safety and tolerability of the treatment, detected by examining the adverse events expected at local level.
Measured: Three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 20221 Sep 2023

First posted31 May 2025
Study start26 Jul 2022
Primary completion1 Sep 2023
Study completion1 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06997991
Sponsor's protocol ID: 1155772|26/07/2022
Acronym: AMG_1
Status last verified: May 2025
First submitted: 22 May 2025
Last updated: 31 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: IPD will not be shared due to confidentiality and regulatory constraints, except for possible use in scientific publications in anonymized or aggregated format.

Publications

Mayoly A, Witters M, Jouve E, Bec C, Iniesta A, Kachouh N, Veran J, Grimaud F, Zavarro AC, Fernandez R, Bendahan D, Giraudo L, Dumoulin C, Chagnaud C, Casanova D, Sabatier F, Legre R, Jaloux C, Magalon J. Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study. J Clin Med. 2022 Sep 29;11(19):5786. doi: 10.3390/jcm11195786.
PubMed 36233654
Erne HC, Cerny MK, Ehrl D, Bauer AT, Schmauss V, Moog P, Broer PN, Loew S, Schmauss D. Autologous Fat Injection versus Lundborg Resection Arthroplasty for the Treatment of Trapeziometacarpal Joint Osteoarthritis. Plast Reconstr Surg. 2018 Jan;141(1):119-124. doi: 10.1097/PRS.0000000000003913.
PubMed 28922320
Cook GS, Lalonde DH. MOC-PSSM CME article: Management of thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-9. doi: 10.1097/01.prs.0000294708.70340.8c.
PubMed 18182958
De Francesco F, Gravina P, Busato A, Farinelli L, Soranzo C, Vidal L, Zingaretti N, Zavan B, Sbarbati A, Riccio M, Gigante A. Stem Cells in Autologous Microfragmented Adipose Tissue: Current Perspectives in Osteoarthritis Disease. Int J Mol Sci. 2021 Sep 22;22(19):10197. doi: 10.3390/ijms221910197.
PubMed 34638538
Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
PubMed 31908163
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
PubMed 18279766
Farinelli L, Riccio M, Gigante A, De Francesco F. Pain Management Strategies in Osteoarthritis. Biomedicines. 2024 Apr 4;12(4):805. doi: 10.3390/biomedicines12040805.
PubMed 38672160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of Intraarticular Administration of Micro-grafts of Adipose Tissue (Adipo-micro-grafts) in the Treatment of Osteoarthritis of the Trapezium-metacarpal Joint
ClinicalTrials.gov ID: NCT06997991
Acronym / sponsor ID: AMG_1 / 1155772|26/07/2022
Conditions: Osteoarthritis, Osteoarthritis Thumbs
Keywords: adipose stem cells, Rigenera protocol, trapeziometacarpal arthritis, microfragmented adipose tissue
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Azienda Ospedaliero, Universitaria Ospedali RiunitiUniversity, hospital or other
Study start: 26 Jul 2022 (actual)
Primary completion: 1 Sep 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 31 May 2025 (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.

The objective of this interventional study is the Change in the Michigan Hand Questionnaire (MHQ) score over time in subjects with Eaton Littler grade II and III trapeziometacarpal osteoarthritis.

The main questions to be answered are:

primary outcomes: Differences in the change in the MHQ scale measured as a reduction in the score result of 12 points within 6 months from preoperative.
secondary outcomes: Change from baseline in hand function measured by grip strength (Gripstrength); Change from baseline in hand function by lateral grip strength (tippinch and tripodpinch); Change in the Visual Analogue Scale (VAS) pain scale before the procedure then after the procedure, at 1, 3 and 6 months; Safety and tolerance of the treatments.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adipose micro-grafts	Experimental	Procedure: adipose micro-grafts injectionPatients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signed written informed consent.
Male or female aged ≥ 40 and ≤ 75 years
Normal axial alignment
Eaton/Littler stage 2-3
MHQ pain scale

Key exclusion criteria (7 listed)

Pregnant and/or breastfeeding women.
If a woman, of childbearing age and the subject is not using a highly effective method of birth control and is not willing to use it during participation in the clinical trial. Highly effective methods of birth control include: combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal); progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;
Intra-articular injection within 3 months of treatment.
Immunocompromised for reasons such as corticosteroid therapy, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
Previous hand surgery within the last 6 months

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
adipose micro-grafts injectionPatients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe.	Procedure or surgery	Adipose micro-grafts

Primary outcome

Change in hand and upper limb function measured by the Michigan Hand questionnaire
Time frame: The MHQ will be administered at three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention, in order to monitor clinical progress and treatment effectiveness.
The Michigan Hand Questionnaire (MHQ) is a validated instrument specifically designed to assess hand function and the impact of upper extremity conditions on quality of life. The questionnaire explores six main dimensions: general function, activities of daily living (ADL), pain, aesthetics, patient satisfaction, and work function. The score for each domain is converted to a scale of 0 to 100, where: 100 represents the best perceived functional outcome, 0 represents the worst outcome. For some subsections (such as pain), the scale is reversed to ensure correct interpretation of the scores.

1 secondary outcome

Evaluation of: 1. Change from baseline in hand function measured by grip strength 2. Change from baseline in hand function measured by lateral grip strength (tip pinch and tripod pinch) 3. Change in visual analogue scale of pain (VAS) over time 4.Safety
Time frame: Three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention.

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 31 May 2025.
Background: PubMed 36233654Mayoly A, Witters M, Jouve E, Bec C, Iniesta A, Kachouh N, Veran J, Grimaud F, Zavarro AC, Fernandez R, Bendahan D, Giraudo L, Dumoulin C, Chagnaud C, Casanova D, Sabatier F, Legre R, Jaloux C, Magalon J. Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study. J Clin Med. 2022 Sep 29;11(19):5786. doi: 10.3390/jcm11195786.
Background: PubMed 28922320Erne HC, Cerny MK, Ehrl D, Bauer AT, Schmauss V, Moog P, Broer PN, Loew S, Schmauss D. Autologous Fat Injection versus Lundborg Resection Arthroplasty for the Treatment of Trapeziometacarpal Joint Osteoarthritis. Plast Reconstr Surg. 2018 Jan;141(1):119-124. doi: 10.1097/PRS.0000000000003913.
Background: PubMed 18182958Cook GS, Lalonde DH. MOC-PSSM CME article: Management of thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-9. doi: 10.1097/01.prs.0000294708.70340.8c.
Background: PubMed 34638538De Francesco F, Gravina P, Busato A, Farinelli L, Soranzo C, Vidal L, Zingaretti N, Zavan B, Sbarbati A, Riccio M, Gigante A. Stem Cells in Autologous Microfragmented Adipose Tissue: Current Perspectives in Osteoarthritis Disease. Int J Mol Sci. 2021 Sep 22;22(19):10197. doi: 10.3390/ijms221910197.
Background: PubMed 31908163Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
Background: PubMed 18279766Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
Background: PubMed 38672160Farinelli L, Riccio M, Gigante A, De Francesco F. Pain Management Strategies in Osteoarthritis. Biomedicines. 2024 Apr 4;12(4):805. doi: 10.3390/biomedicines12040805.
Individual participant dataSharing planned: Undecided. IPD will not be shared due to confidentiality and regulatory constraints, except for possible use in scientific publications in anonymized or aggregated format.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

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 adipose micro-grafts injection in people with Osteoarthritis and Osteoarthritis Thumbs, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

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 7 inclusion and 7 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 31 May 2025. 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 Italy. 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?

Change in hand and upper limb function measured by the Michigan Hand questionnaire (time frame: The MHQ will be administered at three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention, in order to monitor clinical progress and treatment effectiveness.). 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 NCT06997991, which also lists 7 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 31 May 2025.