Clinical trial NCT06209957: Study of Single Platelet-Rich Plasma Local Injection Vs. Single Corticosteroid Local Injection in Carpal Tunnel Syndrome
Official title: Evaluation of Platelet-Rich Plasma Injection vs. Corticosteroid Injection in Idiopathic Carpel Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Corticosteroids
Platelet-Rich Plasma
Nerve Conduction Study
Boston Questionnaire
Visual Analogue Scale
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, interventional, comparative double-blinded study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual analog scale
timeFrame: before and after three months from injection time
measure: Symptom severity scale of the Boston Carpal Tunnel Questionnaire
timeFrame: before and after three months from injection time
measure: Functional severity scale of the Boston Carpal Tunnel Questionnaire
timeFrame: before and after three months from injection time
measure: Median nerve sensory peak latency
timeFrame: before and after three months from injection time
measure: Median nerve distal motor latency
timeFrame: before and after three months from injection time
measure: Median nerve sensory amplitude
timeFrame: before and after three months from injection time
measure: Median nerve motor amplitude
timeFrame: before and after three months from injection time
measure: Median nerve sensory conduction velocity
timeFrame: before and after three months from injection time
measure: Median nerve motor conduction velocity
timeFrame: before and after three months from injection time
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, Menoufia University
state: Menoufia
Study officials:
affiliation: Menoufia University
name: Saga F El-Gazzar
role: STUDY_DIRECTOR
References: