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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06209957
Enrollment
40
Registered
2024-01-18
Start date
2017-06-01
Completion date
2019-01-01
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

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

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.

Interventions

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

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

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

A prospective, interventional, comparative double-blinded study.

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scalebefore and after three months from injection timeThe pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Symptom severity scale of the Boston Carpal Tunnel Questionnairebefore and after three months from injection timePain severity evaluation
Functional severity scale of the Boston Carpal Tunnel Questionnairebefore and after three months from injection timeHand function evaluation
Median nerve sensory peak latencybefore and after three months from injection timeSensory conduction evaluation of median nerve
Median nerve distal motor latencybefore and after three months from injection timeMotor conduction evaluation of the median nerve.
Median nerve sensory amplitudebefore and after three months from injection timeSensory conduction evaluation of the median nerve
Median nerve motor amplitudebefore and after three months from injection timeMotor conduction evaluation of the median nerve.
Median nerve sensory conduction velocitybefore and after three months from injection timeSensory conduction evaluation of the median nerve
Median nerve motor conduction velocitybefore and after three months from injection timeMotor conduction evaluation of the median nerve.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026