Cubital Tunnel SyndromeNCT02801461
The Effect of ESWT for Cubital Tunnel Syndrome
A study testing extracorporeal shock wave therapy in people with Cubital 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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2016to 31 Dec 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 80 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 cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th 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 cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.
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 Cubital 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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome.
Read the detailed description
Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.
Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- extracorporeal shock wave therapy
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave therapyDevice
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 | ESWT was given once a week for 3 weeks. Receives: Device: extracorporeal shock wave therapy |
| One-session of ESWT | Active comparator | Single ESWT was given. Receives: Device: extracorporeal shock wave therapy |
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 (2)
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Using the Disabilities of the Arm, Shoulder and Hand 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 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 startOct 2016
- Primary completionDec 2017
- Study completion31 Dec 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 Cubital 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
- Investigator
- Enrolment
- 7 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
- NCT02801461
- Sponsor's protocol ID
- TSGHIRB: 2-105-05-032
- Status last verified
- Apr 2018
- First submitted
- 10 Jun 2016
- Last updated
- 25 Apr 2018
- 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 26610183Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wustner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4.
PubMed 21547883
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. 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 Cubital Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02801461
- Acronym / sponsor ID
- TSGHIRB: 2-105-05-032
- Conditions
- Cubital Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome.
Detailed description
Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.
Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. 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 (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-sessions of ESWT | Experimental | Device: extracorporeal shock wave therapyESWT was given once a week for 3 weeks. |
| One-session of ESWT | Active comparator | Device: extracorporeal shock wave therapySingle ESWT was given. |
Who may qualify
- Ages
- 20 to 80 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 cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th 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 cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.
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 |
|---|---|---|
| extracorporeal shock wave therapyShock 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 | 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)
2 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 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 25 Apr 2018.
- Background: 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.
- Background: PubMed 21547883Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wustner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4.
- 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 extracorporeal shock wave therapy in people with Cubital 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 25 Apr 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. 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 NCT02801461, 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 25 Apr 2018.