Carpal Tunnel SyndromePRP-CTSNCT03548259
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
A study testing Platelet-rich plasma and Platelet-poor plasma in people with Carpal Tunnel Syndrome, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Platelet-rich plasma and Platelet-poor plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2018to 5 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Carpal Tunnel Syndrome (CTS)
- Conservative treatment failure
Who cannot join
- Previous CTS surgery on the same side
- Wrist fracture/trauma in history
- Polyneuropathy
- Diabetes mellitus
- Cervical neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Platelet-rich plasma, Platelet-poor plasma
- Keywords
- Carpal Tunnel Syndrome, Platelet-rich plasma, Surgery
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaProcedure or surgery
Platelet-rich plasma injection
Platelet-poor plasmaProcedure or surgery
Platelet-poor plasma injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Platelet-rich plasma Receives: Procedure: Platelet-rich plasma; Procedure: Platelet-poor plasma |
| Platelet-poor plasma | Placebo comparator | Platelet-poor plasma Receives: Procedure: Platelet-rich plasma; Procedure: Platelet-poor plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength measured with dynamometer
Measured: 6 weeks
Secondary outcomes (4)
Pain
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".
Measured: 6 weeks
Sympton severity
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.
Measured: 6 weeks
Functional status
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.
Measured: 6 weeks
Wound healing
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start5 Jun 2018
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (Parallel Assignment)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- Ignacio Pérez, PhD, Study chair, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548259
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-18
- Acronym
- PRP-CTS
- Status last verified
- Feb 2019
- First submitted
- 24 May 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
- ClinicalTrials.gov ID
- NCT03548259
- Acronym / sponsor ID
- PRP-CTS / UNIVERSITY CARDENAL HERRERA-18
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Platelet-rich plasma, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (Parallel Assignment)
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Platelet-rich plasma, Procedure: Platelet-poor plasmaPlatelet-rich plasma |
| Platelet-poor plasma | Placebo comparator | Procedure: Platelet-rich plasma, Procedure: Platelet-poor plasmaPlatelet-poor plasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Carpal Tunnel Syndrome (CTS)
- Conservative treatment failure
Key exclusion criteria (5 listed)
- Previous CTS surgery on the same side
- Wrist fracture/trauma in history
- Polyneuropathy
- Diabetes mellitus
- Cervical neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasmaPlatelet-rich plasma injection | Procedure or surgery | Experimental, Platelet-poor plasma |
| Platelet-poor plasmaPlatelet-poor plasma injection | Procedure or surgery | Experimental, Platelet-poor plasma |
Primary outcome
Hand grip strength
Time frame: 6 weeks
Hand grip strength measured with dynamometer
4 secondary outcomes
Pain
Time frame: 6 weeks
Sympton severity
Time frame: 6 weeks
Functional status
Time frame: 6 weeks
Wound healing
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Pérez, PhD study chair
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma and Platelet-poor plasma in people with Carpal Tunnel Syndrome, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.