Hydrodissection Between Normal Saline and a Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in CTS

NCT05577676 | Completed

• 1 other identifier: 0161
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; CTS; Hydrodissection; Normal Saline; Triamcinolone; Ultrasound Guided

Outcome Measures

Primary Outcomes (1)

• Carpal Tunnel Syndrome disease severity

  It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)

  3 months

Secondary Outcomes (1)

• Cross-Sectional Area (CSA) of the Median Nerve

  3 months

Study Arms (2)

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.

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.

Drug: Ultrasound-guided Hydrodissection of the Median Nerve

Interventions

Ultrasound-guided Hydrodissection of the Median Nerve DRUG

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.

Also known as: Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline, Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone Acetonide

Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline; Hydrodissection with Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangladesh College Of Physicians And Surgeons (BCPS): lead

Study Sites (1)

Shaheed Suhrawardy Medical College Hospital

Dhaka, 1207, Bangladesh

Location

Related Publications (13)

• 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.

  PMID: 32682938 BACKGROUND

• O'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.

  PMID: 12535461 BACKGROUND

• Caliandro 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.

  PMID: 16325467 BACKGROUND

• Katz 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.

  PMID: 9582945 BACKGROUND

• Stevens 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.

  PMID: 1434881 BACKGROUND

• Kleggetveit 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.

  PMID: 29894306 BACKGROUND

• Tetro 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.

  PMID: 9619944 BACKGROUND

• Tai 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.

  PMID: 22542258 BACKGROUND

• Chang 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.

  PMID: 32162601 BACKGROUND

• Wu 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.

  PMID: 30339737 BACKGROUND

• Lee 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.

  PMID: 25546691 BACKGROUND

• Kaile 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.

  PMID: 29020874 BACKGROUND

• Wang 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.

  PMID: 21282223 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Saline Solution; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dr Mamunul Abedin

  Bangladesh College of Physicians and Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Trainee

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: September 13, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)