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Clinical Trials/CTRI/2024/01/061292
CTRI/2024/01/061292Not yet recruitingPhase 2/3

Comparsion of 5% dextrose versus triamcinolone in the carpal tunnel syndrome patients refractory to conservative therapy

Department of anaesthesiology and critical care,Jawaharlal nehru medical college,AMU,aligarh1 site in 1 country50 target enrollmentStarted: January 15, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
to compare the efficacy of 5% dextrose versus triamcinolone injection

Study Overview

Brief Summary

A randomised controlled study to assess the efficacy of 5% dextrose and triamcinolone in ultrasound guided median nerve block in patients of carpal tunnel syndrome refractory to conservative therapy.

Carpal tunnel syndrome (CTS) is one of the most common focal entrapment neuropathies. Although the exact etiology remains unclear, high-pressure-related intracarpal tunnel compression of the median nerve (MN), progressing ischemia, and mechanical strangulation are common mechanisms. The therapeutic managements for CTS depend on the disease severity, varying from a conservative treatment to surgical interventions. Surgical interventions are recommended in severe cases or mild to moderate who  fail to respond to conservative treatments. Therefore, there is a need for a method to treat CTS without surgical interventions.

Different concentration of dextrose has been used, more commonly 5% dextrose(D5W) is used as it has same osmolarity as of normal saline. Additionally concentration upto 10% of D5W is used. . It is also hypothesized that dextrose in less concentration decrease neurogenic inflammation.

Corticosteriod is most used for perineural injection under blind or ultrasound guided technique in CTS patient. Possible adverse effects of corticosteroids like myelin degeneration ,tendon rupture, soft tissue atrophy, steroid flare and hot flushes.

Perineural injection using both D5W and corticosteroid were commonly used in clinical practice for treating CTS

Therefore, we designed the study with the aim to compare the effectiveness between 5% dextrose and triamcinolone injection for mild to moderate cases of carpel tunnel syndrome.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients diagnosed with mild to moderate Carpal tunnel syndrome with symptoms of Nocturnal paresthesia/dysthesia with or without pain over the subjected, which could be associated with posture or overuse of the wrist, or relieved with shaking motion of the hand may or may not be associated with numbness in the sensory distribution of Median nerve.

Exclusion Criteria

  • patients with history of polyneuropathy, brachial plexopathy, thoracic outlet syndrome or wrist surgery.
  • patients with History of inflammatory arthritis, hypothyroidism, pregnancy, and rheumatological disorder or having pacemaker.
  • patients who are on warfarin use, previous steroid injection for CTS, trauma or neoplasm at injection site, hypersensitivity to corticosteroid, skin infection at site of infection.

Outcomes

Primary Outcomes

to compare the efficacy of 5% dextrose versus triamcinolone injection

Time Frame: Both the groups will be assessed prior to injection and 1,3, and 6 weeks post injection

Secondary Outcomes

  • study the side effects and complications of drugs used(during the follow up period of 6 weeks any complications related to drug administered)

Investigators

Sponsor
Department of anaesthesiology and critical care,Jawaharlal nehru medical college,AMU,aligarh
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dewanshi Agrawal

Jawaharlal nehru medical college,aligarh muslim university,aligarh

Study Sites (1)

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