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NCT Number: NCT02539186

The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.

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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

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Neihu, 886, Taiwan

About this study

The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. We performe a prospective study to investigate the effect of PRP in patients with carpal tunnel syndrome.

Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and control group received night splint. The evaluation was performed pretreatment as well as on the 1st, 4th, 8th, 12th, 16th and 24 week after the treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 20-80 year-old.
  • Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion criteria

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

Treatment and study plan

Platelet rich plasma

Biological

Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve

Splint

Device

Primary outcomes

  1. Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Time frame: 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Visual analog scale (VAS)

Secondary outcomes

  1. Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

    Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.

  2. Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

    Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

  3. Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

    Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).

  4. Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

    Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
Oct 11, 2017

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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