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

NCT06209957 | Completed Phase 4

• 1 other identifier: PRP in CTS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Corticosteroids; Platelet-Rich Plasma; Nerve Conduction Study; Boston Questionnaire; Visual Analogue Scale

Outcome Measures

Primary Outcomes (9)

• Visual analog scale

  The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)

  before and after three months from injection time

• Symptom severity scale of the Boston Carpal Tunnel Questionnaire

  Pain severity evaluation

  before and after three months from injection time

• Functional severity scale of the Boston Carpal Tunnel Questionnaire

  Hand function evaluation

  before and after three months from injection time

• Median nerve sensory peak latency

  Sensory conduction evaluation of median nerve

  before and after three months from injection time

• Median nerve distal motor latency

  Motor conduction evaluation of the median nerve.

  before and after three months from injection time

• Median nerve sensory amplitude

  Sensory conduction evaluation of the median nerve

  before and after three months from injection time

• Median nerve motor amplitude

  Motor conduction evaluation of the median nerve.

  before and after three months from injection time

• Median nerve sensory conduction velocity

  Sensory conduction evaluation of the median nerve

  before and after three months from injection time

• Median nerve motor conduction velocity

  Motor conduction evaluation of the median nerve.

  before and after three months from injection time

Study Arms (2)

Group I

ACTIVE COMPARATOR

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.

Drug: Local corticosteroid injection

Group II

ACTIVE COMPARATOR

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.

Drug: Platelet-rich Plasma Local injection

Interventions

Local corticosteroid injection DRUG

Local corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL

Group I

Platelet-rich Plasma Local injection DRUG

Platelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection.

Group II

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Officials

• Saga F El-Gazzar

  Menoufia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant of physical medicine, rheumatology and rehabilitation

Model Details: A prospective, interventional, comparative double-blinded study.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 18, 2024
• Study Start: June 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)