Carpal Tunnel SyndromeNCT02800187
The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
A study testing ESWT in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome. 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?
- ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to Oct 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 Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome
The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.
Read the detailed description
The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.
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
- ESWT
- 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.
ESWTDevice
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 |
|---|---|---|
| three-sessions of ESWT | Experimental | Active three-sessions of ESWT ( once a week for 3 weeks) was given. Receives: Device: ESWT |
| one-session of ESWT | Active comparator | One-session of ESWTactive ESWT was given. Receives: Device: ESWT |
| Night splint | Active comparator | The night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. Another 3 sessions of sham ESWT was given. Receives: Device: ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.
Visual analog scale (VAS)
Measured: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary outcomes (3)
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
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 startApr 2016
- Primary completionOct 2017
- Study completionOct 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800187
- Sponsor's protocol ID
- TSGHIRB: 2-105-05-031
- Status last verified
- Oct 2017
- First submitted
- 10 Jun 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wu 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 26610183Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.
PubMed 23044704
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02800187
- Acronym / sponsor ID
- TSGHIRB: 2-105-05-031
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 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 shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.
Detailed description
The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.
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
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| three-sessions of ESWT | Experimental | Device: ESWTActive three-sessions of ESWT ( once a week for 3 weeks) was given. |
| one-session of ESWT | Active comparator | Device: ESWTOne-session of ESWTactive ESWT was given. |
| Night splint | Active comparator | Device: ESWTThe night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. Another 3 sessions of sham ESWT was given. |
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 |
|---|---|---|
| ESWTShock 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 | Night splint, one-session of ESWT, three-sessions of ESWT |
Primary outcome
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
Visual analog scale (VAS)
3 secondary outcomes
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
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 11 Oct 2017.
- 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.
- Results publication: PubMed 23044704Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT 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 11 Oct 2017. 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 4th, 8th, 12th, 16th and 24th weeks after treatment. (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 NCT02800187, 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 11 Oct 2017.