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

Evaluation of Platelet-Rich Plasma Injection vs. Corticosteroid Injection in Idiopathic Carpel Tunnel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Local corticosteroid injection; Drug: Platelet-rich Plasma Local injection

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Faculty of Medicine, Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Local corticosteroid injection; Local corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL
Active Comparator: 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.	Drug: Platelet-rich Plasma Local injection; Platelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Director: Saga F El-Gazzar, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Visual Analogue Scale; Corticosteroids; Platelet-Rich Plasma; Nerve Conduction Study; Boston Questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: PRP in CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient enrollment started June 2017 to early January 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No