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

NCT ID: NCT06209957

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-01-01

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

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 Type: ACTIVE_COMPARATOR

Local corticosteroid injection

Intervention Type: DRUG

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

Group II

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.

Group Type: ACTIVE_COMPARATOR

Platelet-rich Plasma Local injection

Intervention Type: DRUG

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

Interventions

Local corticosteroid injection

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

Intervention Type: DRUG

Platelet-rich Plasma Local injection

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Aya Allam

Teaching Assistant of physical medicine, rheumatology and rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saga F El-Gazzar

Role: STUDY_DIRECTOR

Menoufia University

Locations

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

PRP in CTS

Identifier Type: -

Identifier Source: org_study_id