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NCT Number: NCT06209957

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

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Local corticosteroid injection

Drug

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

Platelet-rich Plasma Local injection

Drug

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

Primary outcomes

  1. Visual analog scale

    Time frame: before and after three months from injection time

    The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)

  2. Symptom severity scale of the Boston Carpal Tunnel Questionnaire

    Time frame: before and after three months from injection time

    Pain severity evaluation

  3. Functional severity scale of the Boston Carpal Tunnel Questionnaire

    Time frame: before and after three months from injection time

    Hand function evaluation

  4. Median nerve sensory peak latency

    Time frame: before and after three months from injection time

    Sensory conduction evaluation of median nerve

  5. Median nerve distal motor latency

    Time frame: before and after three months from injection time

    Motor conduction evaluation of the median nerve.

  6. Median nerve sensory amplitude

    Time frame: before and after three months from injection time

    Sensory conduction evaluation of the median nerve

  7. Median nerve motor amplitude

    Time frame: before and after three months from injection time

    Motor conduction evaluation of the median nerve.

  8. Median nerve sensory conduction velocity

    Time frame: before and after three months from injection time

    Sensory conduction evaluation of the median nerve

  9. Median nerve motor conduction velocity

    Time frame: before and after three months from injection time

    Motor conduction evaluation of the median nerve.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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