Carpal Tunnel SyndromeNCT05577676
Hydrodissection Between Normal Saline and a Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in CTS
A study testing Ultrasound-guided Hydrodissection of the Median Nerve in people with Carpal Tunnel Syndrome, run by Bangladesh College Of Physicians And Surgeons (BCPS) at 1 site in Bangladesh.
Trial summary
The goal of this randomized clinical trial is to compare the functional outcome of hydrodissection of the median nerve by normal saline only and a combination of triamcinolone acetonide, lidocaine, and normal saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Ultrasound-guided Hydrodissection of the Median Nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBangladesh
- Study dates
- 13 Sep 2022to 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having pain and/or numbness, paresthesia in median nerve or glove distribution area with night symptoms for more than 4 weeks
- Patients age from 18 years of both sexes
- Electrodiagnostically (by NCS) confirmed and categorized as mild or moderate carpal tunnel syndrome
- Willing to participate
Who cannot join
- Patients having other diseases, like: Cervical radiculopathy, Other neuropathy
- History of taking systemic corticosteroids within 04-weeks prior study
- Pregnancy
- History of distal forearm or wrist fracture, trauma or deformity
- Previous CTS surgery or steroid injection in carpal tunnel
- Thenar atrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Comparison of Ultrasound-guided Hydrodissection Between Normal Saline and Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in Mild to Moderate Carpal Tunnel Syndrome: A Single Blinded Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the functional outcome of hydrodissection of the median nerve by normal saline only and a combination of triamcinolone acetonide, lidocaine, and normal saline.
The main question it aims to answer are:
Read more
- What is the outcome comparison of ultrasound-guided hydrodissection between normal saline only and combination of triamcinolone acetonide, normal saline, and lidocaine in mild to moderate carpal tunnel syndrome?
Participants diagnosed with mild or moderate CTS will be randomly assigned to two groups and be hydrodissected under ultrasound guidance.
Researchers will compare if normal saline gives similar or better functional outcomes than steroids.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy caused by median nerve compression in carpal tunnel characterized by nocturnal paresthesia, tingling, numbness and pain involving glove or median distribution in hand. Almost all patients are from working group of different occupations.
The non-surgical treatments are for patients having mild to moderate CTS and these include oral steroids, drugs, braces, ultrasound therapy, tendon-gliding exercises, local steroid injection or hydrodissection etc. Hydrodissection for CTS includes injecting fluid around the nerve to eliminate the adhesions, restore blood supply and improve kinematic properties of the entrapped nerve. Ultrasound (US) - guided in-plane ulnar approach for hydrodissection in the CTS is more effective \& safer. Traditionally, the steroid (triamcinolone acetonide) combined with normal saline \& lidocaine is injected for this procedure. Though, the steroid injection shows greater clinical improvement only for short term, there are also possible side effects like short-lived local pain (13%), widespread axonal \& myelin degeneration, skin thinning \& depigmentation etc. Whereas, Normal saline (NS) is an isotonic fluid which would be suitable for expanding the perineural space. There are only a few studies comparing the outcome of hydrodissection with normal saline and triamcinolone acetonide in carpal tunnel syndrome, although the steroid injection is well established in management of CTS. Therefore, this study aims to compare the outcome between normal saline alone with combination of triamcinolone, normal saline \& lidocaine. This will be a randomized clinical trial conducting in the department of Physical Medicine and Rehabilitation, Shaheed Suhrawardy Medical College Hospital, Bangladesh for 12-months period following approval of this protocol. Ethical clearance will be obtained from Ethical Review Committee (ERC) of above-mentioned hospital.
A total of 62 (sixty-two) patients above 18 years with clinical features of CTS lasting for more than 04 (four) weeks will be selected by convenience sampling and enrolled by following exclusion-inclusion criteria. All cases will be randomly assigned in to two groups (31 cases in each group) and get following treatment, i.e. Group A: Hydrodissection by 05 ml of normal saline only; Group B: Hydrodissection by 05 ml of combination of triamcinolone acetonide, normal saline \& lidocaine; Both groups: Gabapentin, Neurotropic B vitamins, static wrist splint overnight, tendon gliding exercises, maintaining Activities of Daily Living (ADL) advices. Outcome will be measured by Symptom severity scale (SSS) \& Functional status scale (FSS) of Boston Carpal Tunnel Questionnaire (BCQT), and Numeric pain rating score (NRS-11). Data will be taken before intervention (baseline) and 4th, 8th \& 12th week after intervention. The cross-sectional area of the median nerve at carpal tunnel inlet will also be measured at the baseline \& at the 12th week follow-up.
Data will be collected in a predesigned data collection sheet by face-to-face. The statistical analysis will be conducted using Statistical Package for the Social Sciences (SPSS) version 25 statistical software. The Mann-Whitney U-test and chi-square test/Fisher exact test will be used for continuous and categorical data, respectively. Intragroup data at different follow-up time-points will be evaluated using the Wilcoxon signed rank test. Differences between groups will be measured using the Mann-Whitney U-test. All statistical tests will be two-tailed, with P<0.05 considered significant. Bonferroni correction will be performed for intergroup comparisons at different time-points. All data will be presented as mean, frequency and percentages in tables, line charts etc.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound-guided Hydrodissection of the Median Nerve
- Keywords
- Carpal Tunnel Syndrome, CTS, Hydrodissection, Normal Saline, Triamcinolone, Ultrasound Guided
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Hydrodissection of the Median NerveDrug
Also called Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline, Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone Acetonide
Hydrodissection for CTS includes injecting fluid around the median nerve (MN) with 5 ml volume, 3 ml of which is given in between the transverse carpal ligament \& MN, and 2 ml below the MN under Ultrasound guidance in-plane ulnar approach.
| Study group | Role | What they receive |
|---|---|---|
| Hydrodissection with Normal Saline | Experimental | This group will be hydrodissected by 5 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices. Receives: Drug: Ultrasound-guided Hydrodissection of the Median Nerve |
| Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline | Active comparator | This group will be hydrodissected by 5 ml combination of 1 ml of triamcinolone, 1 ml of lidocaine \& 3 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices. Receives: Drug: Ultrasound-guided Hydrodissection of the Median Nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carpal Tunnel Syndrome disease severity
It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)
Measured: 3 months
Secondary outcomes (1)
Cross-Sectional Area (CSA) of the Median Nerve
It will be measured by ultrasound
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start13 Sep 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Patients of CTS for at least 04 weeks will be selected. Informed written consent will be taken. Data will be collected by face-to-face interview. Total 62 samples will then be randomly allocated into two groups. One group will receive 5 ml of normal saline and another group will receive 5 ml combination of triamcinolone, lidocaine \& normal saline. Both group will also receive Gabapentin, B vitamin, static wrist splint overnight, tendon gliding exercises and ADL advices. After taking all aseptic measures, a 23-gauze needle will be placed between transverse carpal ligament \& median nerve where 3 ml fluid is given and then, at below the median nerve where another 2 ml fluid is injected. The patients will be kept in a sitting position and observed for 10 to 15 minutes before discharge.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh College Of Physicians And Surgeons (BCPS)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md Mamunul Abedin, Bangladesh College Of Physicians And Surgeons (BCPS)
- Investigators
- Dr Mamunul Abedin, Principal investigator, Bangladesh College of Physicians and Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577676
- Sponsor's protocol ID
- 0161
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu PC, Liao KK, Lin KP, Chiu JW, Wu PY, Chou CL, Wang NY, Wang JC. Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1857-1864. doi: 10.1016/j.apmr.2020.06.018. Epub 2020 Jul 16.
PubMed 32682938O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
PubMed 12535461Caliandro P, La Torre G, Aprile I, Pazzaglia C, Commodari I, Tonali P, Padua L. Distribution of paresthesias in Carpal Tunnel Syndrome reflects the degree of nerve damage at wrist. Clin Neurophysiol. 2006 Jan;117(1):228-31. doi: 10.1016/j.clinph.2005.09.001. Epub 2005 Dec 1.
PubMed 16325467Katz JN, Lew RA, Bessette L, Punnett L, Fossel AH, Mooney N, Keller RB. Prevalence and predictors of long-term work disability due to carpal tunnel syndrome. Am J Ind Med. 1998 Jun;33(6):543-50. doi: 10.1002/(sici)1097-0274(199806)33:63.0.co;2-r.
PubMed 9582945Stevens JC, Beard CM, O'Fallon WM, Kurland LT. Conditions associated with carpal tunnel syndrome. Mayo Clin Proc. 1992 Jun;67(6):541-8. doi: 10.1016/s0025-6196(12)60461-3.
PubMed 1434881Kleggetveit IP, Jorum E. Diagnosis of carpal tunnel syndrome. Scand J Pain. 2018 Jul 26;18(3):333-337. doi: 10.1515/sjpain-2018-0089. No abstract available.
PubMed 29894306Tetro AM, Evanoff BA, Hollstien SB, Gelberman RH. A new provocative test for carpal tunnel syndrome. Assessment of wrist flexion and nerve compression. J Bone Joint Surg Br. 1998 May;80(3):493-8. doi: 10.1302/0301-620x.80b3.8208.
PubMed 9619944Tai TW, Wu CY, Su FC, Chern TC, Jou IM. Ultrasonography for diagnosing carpal tunnel syndrome: a meta-analysis of diagnostic test accuracy. Ultrasound Med Biol. 2012 Jul;38(7):1121-8. doi: 10.1016/j.ultrasmedbio.2012.02.026. Epub 2012 Apr 27.
PubMed 22542258Chang KV, Wu WT, Ozcakar L. Ultrasound imaging and guidance in peripheral nerve entrapment: hydrodissection highlighted. Pain Manag. 2020 Mar;10(2):97-106. doi: 10.2217/pmt-2019-0056. Epub 2020 Mar 12.
PubMed 32162601Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
PubMed 30339737Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.
PubMed 25546691Kaile E, Bland JDP. Safety of corticosteroid injection for carpal tunnel syndrome. J Hand Surg Eur Vol. 2018 Mar;43(3):296-302. doi: 10.1177/1753193417734426. Epub 2017 Oct 11.
PubMed 29020874Wang PH, Tsai CL, Lee JS, Wu KC, Cheng KI, Jou IM. Effects of topical corticosteroids on the sciatic nerve: an experimental study to adduce the safety in treating carpal tunnel syndrome. J Hand Surg Eur Vol. 2011 Mar;36(3):236-43. doi: 10.1177/1753193410390760. Epub 2011 Jan 31.
PubMed 21282223
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Comparison of Ultrasound-guided Hydrodissection Between Normal Saline and Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in Mild to Moderate Carpal Tunnel Syndrome: A Single Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05577676
- Acronym / sponsor ID
- 0161
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, CTS, Hydrodissection, Normal Saline, Triamcinolone, Ultrasound Guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bangladesh College Of Physicians And Surgeons (BCPS)University, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 13 Oct 2022 (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 goal of this randomized clinical trial is to compare the functional outcome of hydrodissection of the median nerve by normal saline only and a combination of triamcinolone acetonide, lidocaine, and normal saline.
The main question it aims to answer are:
- What is the outcome comparison of ultrasound-guided hydrodissection between normal saline only and combination of triamcinolone acetonide, normal saline, and lidocaine in mild to moderate carpal tunnel syndrome?
Participants diagnosed with mild or moderate CTS will be randomly assigned to two groups and be hydrodissected under ultrasound guidance.
Researchers will compare if normal saline gives similar or better functional outcomes than steroids.
Detailed description
Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy caused by median nerve compression in carpal tunnel characterized by nocturnal paresthesia, tingling, numbness and pain involving glove or median distribution in hand. Almost all patients are from working group of different occupations.
The non-surgical treatments are for patients having mild to moderate CTS and these include oral steroids, drugs, braces, ultrasound therapy, tendon-gliding exercises, local steroid injection or hydrodissection etc. Hydrodissection for CTS includes injecting fluid around the nerve to eliminate the adhesions, restore blood supply and improve kinematic properties of the entrapped nerve. Ultrasound (US) - guided in-plane ulnar approach for hydrodissection in the CTS is more effective \& safer. Traditionally, the steroid (triamcinolone acetonide) combined with normal saline \& lidocaine is injected for this procedure. Though, the steroid injection shows greater clinical improvement only for short term, there are also possible side effects like short-lived local pain (13%), widespread axonal \& myelin degeneration, skin thinning \& depigmentation etc. Whereas, Normal saline (NS) is an isotonic fluid which would be suitable for expanding the perineural space. There are only a few studies comparing the outcome of hydrodissection with normal saline and triamcinolone acetonide in carpal tunnel syndrome, although the steroid injection is well established in management of CTS. Therefore, this study aims to compare the outcome between normal saline alone with combination of triamcinolone, normal saline \& lidocaine. This will be a randomized clinical trial conducting in the department of Physical Medicine and Rehabilitation, Shaheed Suhrawardy Medical College Hospital, Bangladesh for 12-months period following approval of this protocol. Ethical clearance will be obtained from Ethical Review Committee (ERC) of above-mentioned hospital.
A total of 62 (sixty-two) patients above 18 years with clinical features of CTS lasting for more than 04 (four) weeks will be selected by convenience sampling and enrolled by following exclusion-inclusion criteria. All cases will be randomly assigned in to two groups (31 cases in each group) and get following treatment, i.e. Group A: Hydrodissection by 05 ml of normal saline only; Group B: Hydrodissection by 05 ml of combination of triamcinolone acetonide, normal saline \& lidocaine; Both groups: Gabapentin, Neurotropic B vitamins, static wrist splint overnight, tendon gliding exercises, maintaining Activities of Daily Living (ADL) advices. Outcome will be measured by Symptom severity scale (SSS) \& Functional status scale (FSS) of Boston Carpal Tunnel Questionnaire (BCQT), and Numeric pain rating score (NRS-11). Data will be taken before intervention (baseline) and 4th, 8th \& 12th week after intervention. The cross-sectional area of the median nerve at carpal tunnel inlet will also be measured at the baseline \& at the 12th week follow-up.
Data will be collected in a predesigned data collection sheet by face-to-face. The statistical analysis will be conducted using Statistical Package for the Social Sciences (SPSS) version 25 statistical software. The Mann-Whitney U-test and chi-square test/Fisher exact test will be used for continuous and categorical data, respectively. Intragroup data at different follow-up time-points will be evaluated using the Wilcoxon signed rank test. Differences between groups will be measured using the Mann-Whitney U-test. All statistical tests will be two-tailed, with P<0.05 considered significant. Bonferroni correction will be performed for intergroup comparisons at different time-points. All data will be presented as mean, frequency and percentages in tables, line charts etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients of CTS for at least 04 weeks will be selected. Informed written consent will be taken. Data will be collected by face-to-face interview. Total 62 samples will then be randomly allocated into two groups. One group will receive 5 ml of normal saline and another group will receive 5 ml combination of triamcinolone, lidocaine \& normal saline. Both group will also receive Gabapentin, B vitamin, static wrist splint overnight, tendon gliding exercises and ADL advices. After taking all aseptic measures, a 23-gauze needle will be placed between transverse carpal ligament \& median nerve where 3 ml fluid is given and then, at below the median nerve where another 2 ml fluid is injected. The patients will be kept in a sitting position and observed for 10 to 15 minutes before discharge.
| Arm | Type | Receives |
|---|---|---|
| Hydrodissection with Normal Saline | Experimental | Drug: Ultrasound-guided Hydrodissection of the Median NerveThis group will be hydrodissected by 5 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices. |
| Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline | Active comparator | Drug: Ultrasound-guided Hydrodissection of the Median NerveThis group will be hydrodissected by 5 ml combination of 1 ml of triamcinolone, 1 ml of lidocaine \& 3 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having pain and/or numbness, paresthesia in median nerve or glove distribution area with night symptoms for more than 4 weeks
- Patients age from 18 years of both sexes
- Electrodiagnostically (by NCS) confirmed and categorized as mild or moderate carpal tunnel syndrome
- Willing to participate
Key exclusion criteria (6 listed)
- Patients having other diseases, like: Cervical radiculopathy, Other neuropathy
- History of taking systemic corticosteroids within 04-weeks prior study
- Pregnancy
- History of distal forearm or wrist fracture, trauma or deformity
- Previous CTS surgery or steroid injection in carpal tunnel
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 |
|---|---|---|
| Ultrasound-guided Hydrodissection of the Median NerveAlso: Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline, Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone AcetonideHydrodissection for CTS includes injecting fluid around the median nerve (MN) with 5 ml volume, 3 ml of which is given in between the transverse carpal ligament \& MN, and 2 ml below the MN under Ultrasound guidance in-plane ulnar approach. | Drug | Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline, Hydrodissection with Normal Saline |
Primary outcome
Carpal Tunnel Syndrome disease severity
Time frame: 3 months
It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)
1 secondary outcome
Cross-Sectional Area (CSA) of the Median Nerve
Time frame: 3 months
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 11 Jan 2024.
- Background: PubMed 32682938Hsu PC, Liao KK, Lin KP, Chiu JW, Wu PY, Chou CL, Wang NY, Wang JC. Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1857-1864. doi: 10.1016/j.apmr.2020.06.018. Epub 2020 Jul 16.
- Background: PubMed 12535461O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
- Background: PubMed 16325467Caliandro P, La Torre G, Aprile I, Pazzaglia C, Commodari I, Tonali P, Padua L. Distribution of paresthesias in Carpal Tunnel Syndrome reflects the degree of nerve damage at wrist. Clin Neurophysiol. 2006 Jan;117(1):228-31. doi: 10.1016/j.clinph.2005.09.001. Epub 2005 Dec 1.
- Background: PubMed 9582945Katz JN, Lew RA, Bessette L, Punnett L, Fossel AH, Mooney N, Keller RB. Prevalence and predictors of long-term work disability due to carpal tunnel syndrome. Am J Ind Med. 1998 Jun;33(6):543-50. doi: 10.1002/(sici)1097-0274(199806)33:63.0.co;2-r.
- Background: PubMed 1434881Stevens JC, Beard CM, O'Fallon WM, Kurland LT. Conditions associated with carpal tunnel syndrome. Mayo Clin Proc. 1992 Jun;67(6):541-8. doi: 10.1016/s0025-6196(12)60461-3.
- Background: PubMed 29894306Kleggetveit IP, Jorum E. Diagnosis of carpal tunnel syndrome. Scand J Pain. 2018 Jul 26;18(3):333-337. doi: 10.1515/sjpain-2018-0089. No abstract available.
- Background: PubMed 9619944Tetro AM, Evanoff BA, Hollstien SB, Gelberman RH. A new provocative test for carpal tunnel syndrome. Assessment of wrist flexion and nerve compression. J Bone Joint Surg Br. 1998 May;80(3):493-8. doi: 10.1302/0301-620x.80b3.8208.
- Background: PubMed 22542258Tai TW, Wu CY, Su FC, Chern TC, Jou IM. Ultrasonography for diagnosing carpal tunnel syndrome: a meta-analysis of diagnostic test accuracy. Ultrasound Med Biol. 2012 Jul;38(7):1121-8. doi: 10.1016/j.ultrasmedbio.2012.02.026. Epub 2012 Apr 27.
- Background: PubMed 32162601Chang KV, Wu WT, Ozcakar L. Ultrasound imaging and guidance in peripheral nerve entrapment: hydrodissection highlighted. Pain Manag. 2020 Mar;10(2):97-106. doi: 10.2217/pmt-2019-0056. Epub 2020 Mar 12.
- Background: PubMed 30339737Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
- Background: PubMed 25546691Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.
- Background: PubMed 29020874Kaile E, Bland JDP. Safety of corticosteroid injection for carpal tunnel syndrome. J Hand Surg Eur Vol. 2018 Mar;43(3):296-302. doi: 10.1177/1753193417734426. Epub 2017 Oct 11.
- Individual participant dataSharing planned: No
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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.
Dr Mamunul Abedin principal investigator
Bangladesh College of Physicians and Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Hydrodissection of the Median Nerve in people with Carpal Tunnel Syndrome, run by Bangladesh College Of Physicians And Surgeons (BCPS) at 1 site in Bangladesh.
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 6 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 11 Jan 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 Bangladesh. 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?
Carpal Tunnel Syndrome disease severity (time frame: 3 months). 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 NCT05577676, which also lists 13 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 11 Jan 2024.