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NCT Number: NCT03548259

Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial

The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.

Design: Randomized Controlled Trial. Setting: Local Hospital.

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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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Valencia, 46113, Spain

About this study

Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.

The treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.

Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.

We propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Carpal Tunnel Syndrome (CTS)
  • Conservative treatment failure

Exclusion criteria

  • Previous CTS surgery on the same side
  • Wrist fracture/trauma in history
  • Polyneuropathy
  • Diabetes mellitus
  • Cervical neuropathy

Treatment and study plan

platelet-rich plasma

Procedure

Platelet-rich plasma injection

Platelet-poor plasma

Procedure

Platelet-poor plasma injection

Primary outcomes

  1. Hand grip strength

    Time frame: 6 weeks

    Hand grip strength measured with dynamometer

Secondary outcomes

  1. Pain

    Time frame: 6 weeks

    Pain measured with the Wong-Baker Faces Pain Rating Scale. The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst".

  2. Sympton severity

    Time frame: 6 weeks

    Sympton severity measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire. The Symptom Severity Scale (SSS) contains 11 questions and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.

  3. Functional status

    Time frame: 6 weeks

    Functional status measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire.The Functional Status Scale (FSS) contains 8 items and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.

  4. Wound healing

    Time frame: 6 weeks

    Wound healing measured with the Southampton Wound Assessment Scale. Wounds are scored as 0, I, II, III, IV and V, with a higher score indicating worst healing.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized

Acronym: PRP-CTS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2018
Registry last updated
Feb 4, 2019

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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