Study of Single Platelet-Rich Plasma Local Injection Vs. Single Corticosteroid Local Injection in Carpal Tunnel Syndrome

Phase 4

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Local corticosteroid injection; Drug: Platelet-rich Plasma Local injection

• Registration Number: NCT06209957
• Lead Sponsor: Menoufia University

Brief Summary

This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.

The main question\[s\] it aims to answer are:

* Does platelet-rich plasma injection provide better pain relief for CTS symptoms than steroid injection?

* Does platelet-rich plasma improve parameters of median nerve conduction study than local steroid?

Participants will have:

* A complete history and clinical examination, including sensory and motor examination and provocative tests for CTS.

* Visual analog scale (VAS), Symptom severity scale (SSS), and functional severity scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) before local injection and three months after local injection by the same investigator.

* Nerve conduction studies (NCS) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator.

Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.

Detailed Description

Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.

There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded \[5\]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with mild primary CTS complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. They are selected clinically and confirmed according to Padua's Neurophysiologic Severity Scale (PNSS) for CTS

Exclusion Criteria

• Patients were excluded if they had moderate-to-severe NCS findings, space-occupying lesions within the carpal tunnel, traumatic CTS, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous CTS surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Local corticosteroid injection	Local corticosteroid injection in group I: 1 ml of triamcinolone acetonide (40 milligram/1.0 mL) was locally injected in the wrist using a 25-gauge needle, which was slowly inserted 1 cm proximal to the distal wrist-flexion crease just on the radial side of the palmaris longus tendon. The injection was held if the patient experienced pain or a sensation of pins and needles in the median nerve distribution.
Group II	Platelet-rich Plasma Local injection	Local PRP injection in group II: 2 ml of PRP was injected using the same technique of corticosteroid local injection after 2-step centrifugation of the patient's blood using a specific device. Non-steroidal anti-inflammatory drugs were avoided for two weeks before and after the procedure to prevent the possibility of inhibition of platelet function.

Primary Outcome Measures

Name	Time	Method
Median nerve sensory amplitude	before and after three months from injection time	Sensory conduction evaluation of the median nerve
Symptom severity scale of the Boston Carpal Tunnel Questionnaire	before and after three months from injection time	Pain severity evaluation
Functional severity scale of the Boston Carpal Tunnel Questionnaire	before and after three months from injection time	Hand function evaluation
Median nerve sensory peak latency	before and after three months from injection time	Sensory conduction evaluation of median nerve
Median nerve distal motor latency	before and after three months from injection time	Motor conduction evaluation of the median nerve.
Median nerve motor amplitude	before and after three months from injection time	Motor conduction evaluation of the median nerve.
Visual analog scale	before and after three months from injection time	The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Median nerve sensory conduction velocity	before and after three months from injection time	Sensory conduction evaluation of the median nerve
Median nerve motor conduction velocity	before and after three months from injection time	Motor conduction evaluation of the median nerve.

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt