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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209957
• Other study ID #: PRP in CTS
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Local corticosteroid injection
Local corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL
• Platelet-rich Plasma Local injection
Platelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Symptom severity scale of the Boston Carpal Tunnel Questionnaire	Pain severity evaluation	before and after three months from injection time
Primary	Functional severity scale of the Boston Carpal Tunnel Questionnaire	Hand function evaluation	before and after three months from injection time
Primary	Median nerve sensory peak latency	Sensory conduction evaluation of median nerve	before and after three months from injection time
Primary	Median nerve distal motor latency	Motor conduction evaluation of the median nerve.	before and after three months from injection time
Primary	Median nerve sensory amplitude	Sensory conduction evaluation of the median nerve	before and after three months from injection time
Primary	Median nerve motor amplitude	Motor conduction evaluation of the median nerve.	before and after three months from injection time
Primary	Median nerve sensory conduction velocity	Sensory conduction evaluation of the median nerve	before and after three months from injection time
Primary	Median nerve motor conduction velocity	Motor conduction evaluation of the median nerve.	before and after three months from injection time