Carpal Tunnel Syndrome (CTS)hydrocarpalNCT06590129

Functional Recovery and Pain Reduction Post-hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome (Hydrocarpal)

A study testing hydrodissection of median nerve and Physiotherapy in people with Carpal Tunnel Syndrome (CTS), run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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

This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carpal Tunnel Syndrome (CTS)
What is being tested?: hydrodissection of median nerve and Physiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteMexico
Study dates: 1 Aug 2023to 29 Feb 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men and women ≥18 years of age,
members referred to and treated at the Physical Medicine and Rehabilitation Service of HGR N°1, IMSS Mérida Yucatán, and who had a clinical or electrophysiological diagnosis of carpal tunnel syndrome.

Who cannot join

included a clinical or electrophysiological diagnosis of radiculopathy, plexopathy, polyneuropathy, or other peripheral neuropathy;
current diagnosis of cancer, coagulopathy, thoracic outlet syndrome;
active infectious process or current fracture in the thoracic limb;
previous surgery for carpal tunnel release;
inability to cooperate with filling out scales, physical examination, or infiltration, as clearly detailed.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.
Mérida, Yucatán, 97155

Other trials in Mexico

About this study

Official title: Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome

This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS.

Read the detailed description

This prospective, longitudinal, randomized in two groups clinical study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS, evaluated initially and at 4 and 12 weeks.

Conditions: Carpal Tunnel Syndrome (CTS)
Being tested: hydrodissection of median nerve, Physiotherapy
Keywords: Carpal Tunnel Syndrome, Rehabilitation, physical therapy, Hidrodissection, Physiotherapy, Median nerve neuropathy
Medical subject headings: Carpal Tunnel Syndrome, Median Neuropathy

What participants receive

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

hydrodissection of median nerveProcedure or surgery
Ultrasound guided hydrodissection of median nerve in carpal tunnel with 5% dextrose solution
PhysiotherapyOther
5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

Study groups in NCT06590129
Study group	Role	What they receive
Only Rehabilitation	Active comparator	Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then te patients were enroled to a 15-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities. Receives: Other: Physiotherapy
Median nerve ultrasound guided hidrodissection + rehabilitation	Experimental	Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed. The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group. Receives: Procedure: hydrodissection of median nerve; Other: Physiotherapy

What is being measured

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

Function
Boston´s carpal tunnel questionnaire results, where each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function.
Measured: Initially, 4 and 12 weeks.
Pain
Visual Analogue Scale (VAS) is a pain intensity measurement tool that uses a 10 cm line with two end points to indicate no pain and worst possible pain.
Measured: Initially, 4 and 12 weeks.

Timeline

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

1 Aug 202329 Feb 2024

First posted19 Sep 2024
Study start1 Aug 2023
Primary completion30 Nov 2023
Study completion29 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
Model description: Prospective, longitudinal, randomized clinical study, including 50 patients diagnosed with CTS. Two groups were compared: one received physical therapy and the other received median nerve ultrasound guided hydrodissection plus physiotherapy evaluated initially, 4 and 12 weeks with the Boston questionnaire and the Visual Analogue Scale (VAS).
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06590129
Sponsor's protocol ID: R-2023-3201-068
Acronym: hydrocarpal
Status last verified: Jan 2025
First submitted: 6 Sep 2024
Last updated: 7 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: All IPD collected throughout the trial, only IPD used in the results publication

Publications

Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020 Mar 18;13(3):49. doi: 10.3390/ph13030049.
PubMed 32197544
Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Nov;13(11):2009-2017. doi: 10.1002/term.2950. Epub 2019 Aug 20.
PubMed 31368191
Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
PubMed 28778254
Neo EJR, Shan NT, Tay SS. Hydrodissection for Carpal Tunnel Syndrome: A Systematic Review. Am J Phys Med Rehabil. 2022 Jun 1;101(6):530-539. doi: 10.1097/PHM.0000000000001846. Epub 2021 Jul 14.
PubMed 34261895
Wu YT, Chen YP, Lam KHS, Reeves KD, Lin JA, Kuo CY. Mechanism of Glucose Water as a Neural Injection: A Perspective on Neuroinflammation. Life (Basel). 2022 Jun 2;12(6):832. doi: 10.3390/life12060832.
PubMed 35743863
Kjeken I, Sundin U. Management of carpal tunnel syndrome in primary care. Rheumatology (Oxford). 2023 Feb 1;62(2):495-496. doi: 10.1093/rheumatology/keac396. No abstract available.
PubMed 35894646
Burton CL, Chesterton LS, Chen Y, van der Windt DA. Clinical Course and Prognostic Factors in Conservatively Managed Carpal Tunnel Syndrome: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):836-852.e1. doi: 10.1016/j.apmr.2015.09.013. Epub 2015 Oct 9.
PubMed 26440776
Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
PubMed 32313774
Thiese MS, Gerr F, Hegmann KT, Harris-Adamson C, Dale AM, Evanoff B, Eisen EA, Kapellusch J, Garg A, Burt S, Bao S, Silverstein B, Merlino L, Rempel D. Effects of varying case definition on carpal tunnel syndrome prevalence estimates in a pooled cohort. Arch Phys Med Rehabil. 2014 Dec;95(12):2320-6. doi: 10.1016/j.apmr.2014.08.004. Epub 2014 Aug 28.
PubMed 25175160
Lores Peniche JA, Huchim Lara O, Méndez-Domínguez N. Carpal Tunnel Syndrome: Epidemiological Analysis of Cases Treated in Hospital Services in Mexico. Physiotherapy. 2020;42(2):69-74.

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 recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

All Carpal Tunnel Syndrome (CTS) trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome
ClinicalTrials.gov ID: NCT06590129
Acronym / sponsor ID: hydrocarpal / R-2023-3201-068
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: Carpal Tunnel Syndrome, Rehabilitation, physical therapy, Hidrodissection, Physiotherapy, Median nerve neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Study start: 1 Aug 2023 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 29 Feb 2024 (actual)
First posted: 19 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.

This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, longitudinal, randomized clinical study, including 50 patients diagnosed with CTS. Two groups were compared: one received physical therapy and the other received median nerve ultrasound guided hydrodissection plus physiotherapy evaluated initially, 4 and 12 weeks with the Boston questionnaire and the Visual Analogue Scale (VAS).

Arm	Type	Receives
Only Rehabilitation	Active comparator	Other: PhysiotherapyEvaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then te patients were enroled to a 15-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.
Median nerve ultrasound guided hidrodissection + rehabilitation	Experimental	Procedure: hydrodissection of median nerve, Other: PhysiotherapyEvaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed. The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

men and women ≥18 years of age,
members referred to and treated at the Physical Medicine and Rehabilitation Service of HGR N°1, IMSS Mérida Yucatán, and who had a clinical or electrophysiological diagnosis of carpal tunnel syndrome.

Key exclusion criteria (5 listed)

included a clinical or electrophysiological diagnosis of radiculopathy, plexopathy, polyneuropathy, or other peripheral neuropathy;
current diagnosis of cancer, coagulopathy, thoracic outlet syndrome;
active infectious process or current fracture in the thoracic limb;
previous surgery for carpal tunnel release;
inability to cooperate with filling out scales, physical examination, or infiltration, as clearly detailed.

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
hydrodissection of median nerveUltrasound guided hydrodissection of median nerve in carpal tunnel with 5% dextrose solution	Procedure or surgery	Median nerve ultrasound guided hidrodissection + rehabilitation
Physiotherapy5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.	Other	Median nerve ultrasound guided hidrodissection + rehabilitation, Only Rehabilitation

Primary outcome

Function
Time frame: Initially, 4 and 12 weeks.
Boston´s carpal tunnel questionnaire results, where each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function.
Pain
Time frame: Initially, 4 and 12 weeks.
Visual Analogue Scale (VAS) is a pain intensity measurement tool that uses a 10 cm line with two end points to indicate no pain and worst possible pain.

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 7 Jan 2025.
Background: PubMed 32197544Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020 Mar 18;13(3):49. doi: 10.3390/ph13030049.
Background: PubMed 31368191Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Nov;13(11):2009-2017. doi: 10.1002/term.2950. Epub 2019 Aug 20.
Background: PubMed 28778254Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
Background: PubMed 34261895Neo EJR, Shan NT, Tay SS. Hydrodissection for Carpal Tunnel Syndrome: A Systematic Review. Am J Phys Med Rehabil. 2022 Jun 1;101(6):530-539. doi: 10.1097/PHM.0000000000001846. Epub 2021 Jul 14.
Background: PubMed 35743863Wu YT, Chen YP, Lam KHS, Reeves KD, Lin JA, Kuo CY. Mechanism of Glucose Water as a Neural Injection: A Perspective on Neuroinflammation. Life (Basel). 2022 Jun 2;12(6):832. doi: 10.3390/life12060832.
Background: PubMed 35894646Kjeken I, Sundin U. Management of carpal tunnel syndrome in primary care. Rheumatology (Oxford). 2023 Feb 1;62(2):495-496. doi: 10.1093/rheumatology/keac396. No abstract available.
Background: PubMed 26440776Burton CL, Chesterton LS, Chen Y, van der Windt DA. Clinical Course and Prognostic Factors in Conservatively Managed Carpal Tunnel Syndrome: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):836-852.e1. doi: 10.1016/j.apmr.2015.09.013. Epub 2015 Oct 9.
Background: PubMed 32313774Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
Background: PubMed 25175160Thiese MS, Gerr F, Hegmann KT, Harris-Adamson C, Dale AM, Evanoff B, Eisen EA, Kapellusch J, Garg A, Burt S, Bao S, Silverstein B, Merlino L, Rempel D. Effects of varying case definition on carpal tunnel syndrome prevalence estimates in a pooled cohort. Arch Phys Med Rehabil. 2014 Dec;95(12):2320-6. doi: 10.1016/j.apmr.2014.08.004. Epub 2014 Aug 28.
BackgroundLores Peniche JA, Huchim Lara O, Méndez-Domínguez N. Carpal Tunnel Syndrome: Epidemiological Analysis of Cases Treated in Hospital Services in Mexico. Physiotherapy. 2020;42(2):69-74.
Carpal tunnel syndrome: Treatment and prognosis \[Internet\]. UpToDateLink provided by the sponsor.
Surgery for carpal tunnel syndrome \[Internet\]. UpToDate.Link provided by the sponsor.
Individual participant dataSharing planned: No. All IPD collected throughout the trial, only IPD used in the results publication

Related trials for Carpal Tunnel Syndrome (CTS)

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

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 hydrodissection of median nerve and Physiotherapy in people with Carpal Tunnel Syndrome (CTS), run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 2 inclusion and 5 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 7 Jan 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 Mexico. 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?

Function (time frame: Initially, 4 and 12 weeks.). The study lists 2 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 NCT06590129, which also lists 10 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 7 Jan 2025.