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NCT Number: NCT02800200

The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

About this study

We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 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

Procedure

Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

Shock wave

Device

Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).

Primary outcomes

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

    Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

    Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary outcomes

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

    Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

    Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

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

    Time frame: Pre-treatment, 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 4th, 8th, 12th, 16th and 24th weeks

    Time frame: Pre-treatment, 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).

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2016
Registry last updated
Aug 2, 2018

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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