Carpal Tunnel SyndromeNCT02986828
Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome
A study testing platelet rich plasma, Normal saline and Ultrasound in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- platelet rich plasma, Normal saline and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2016to 30 Oct 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
Who cannot join
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- 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 Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.
Read the detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- platelet rich plasma, Normal saline, Ultrasound
- Keywords
- platelet rich plasma, Hydrodissection
- 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 plasmaDrug
Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
Normal salineDrug
Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma injection | Experimental | The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies. Receives: Drug: platelet rich plasma; Device: Ultrasound |
| Normal saline | Active comparator | Normal saline for ultrasound-guided hydrodissection Receives: Drug: Normal saline; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary outcomes (4)
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection
The finger pinch strength was measured using 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
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 26 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986828
- Sponsor's protocol ID
- PRP and hydrodissection
- Status last verified
- Oct 2019
- First submitted
- 6 Dec 2016
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.
PubMed 24168291Sanchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.
PubMed 23519544Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4.
PubMed 24425846Malahias 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 26807124
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02986828
- Acronym / sponsor ID
- PRP and hydrodissection
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- platelet rich plasma, Hydrodissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 8 Dec 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.
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.
Detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma injection | Experimental | Drug: platelet rich plasma, Device: UltrasoundThe platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies. |
| Normal saline | Active comparator | Drug: Normal saline, Device: UltrasoundNormal saline for ultrasound-guided hydrodissection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
Key exclusion criteria (8 listed)
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
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 plasmaUltrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve. | Drug | platelet rich plasma injection |
| Normal salineUltrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve. | Drug | Normal saline |
| Ultrasound | Device | Normal saline, platelet rich plasma injection |
Primary outcome
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
4 secondary outcomes
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
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 31 Oct 2019.
- Results publication: PubMed 24168291Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.
- Results publication: PubMed 23519544Sanchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.
- Results publication: PubMed 24425846Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4.
- Results publication: 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.
- Individual participant dataSharing planned: Yes
Related trials for Carpal Tunnel Syndrome
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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
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, Normal saline and Ultrasound 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 8 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 31 Oct 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 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. 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 pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection (time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection). 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 NCT02986828, which also lists 4 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 31 Oct 2019.