Carpal Tunnel SyndromeNCT02800200
The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
A study testing Platelet rich plasma and shock wave in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Platelet rich plasma and shock wave
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jun 2016to 15 Sep 2017
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886
About this study
Official title: The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With 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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Platelet rich plasma, shock wave
- Keywords
- platelet rich plasma, extracorporeal shock wave
- 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
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
shock waveDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma | Experimental | The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups. Receives: Procedure: Platelet rich plasma; Device: shock wave |
| Active shock wave | Experimental | One-session active shock wave 2 weeks later after PRP injection was performed in intervention group. Receives: Procedure: Platelet rich plasma; Device: shock wave |
| Sham shock wave | Placebo comparator | One-session sham shock wave 2 weeks later after PRP injection was performed in control group. Receives: Procedure: Platelet rich plasma; Device: shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
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.
Measured: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary outcomes (3)
Change from baseline of pain on 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.
Measured: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Measured: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
Measured: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start16 Jun 2016
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
- Investigators
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800200
- Sponsor's protocol ID
- TSGHIRB No: 2-105-05-026
- Status last verified
- Jul 2018
- First submitted
- 10 Jun 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
PubMed 26807124Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10.
PubMed 26610183
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02800200
- Acronym / sponsor ID
- TSGHIRB No: 2-105-05-026
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- platelet rich plasma, extracorporeal shock wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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) 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma | Experimental | Procedure: Platelet rich plasma, Device: shock waveThe ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups. |
| Active shock wave | Experimental | Procedure: Platelet rich plasma, Device: shock waveOne-session active shock wave 2 weeks later after PRP injection was performed in intervention group. |
| Sham shock wave | Placebo comparator | Procedure: Platelet rich plasma, Device: shock waveOne-session sham shock wave 2 weeks later after PRP injection was performed in control group. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 plasmaSono-guided injection with 3 cc Platelet rich plasma were performed in both groups. | Procedure or surgery | Active shock wave, Platelet rich plasma, Sham shock wave |
| shock waveShock 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). | Device | Active shock wave, Platelet rich plasma, Sham shock wave |
Primary outcome
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.
3 secondary outcomes
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
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
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
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 2 Aug 2018.
- Background: PubMed 26807124Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
- Results publication: PubMed 26610183Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10.
- Individual participant dataSharing planned: Yes
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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.
Yung-Tsan Wu, MD principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
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 shock wave in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 2 Aug 2018. 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 Taiwan. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800200, which also lists 2 linked publications.
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 2 Aug 2018.