Carpal Tunnel SyndromeNCT05253729
Efficacy of Focused Shockwave Therapy in Patients With CTS
A study testing Focused ESWT in people with Carpal Tunnel Syndrome, run by Mahidol University at 1 site in Thailand.
Trial summary
Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Focused ESWT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2018to 30 Sep 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who were diagnosed as CTS based on the American Academy of neurology
- Participants who have electrodiagnostic evidence of CTS according to American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) guidelines for diagnosis of CTS. The severity of median nerve compression at wrist was moderate to severe degree.
- Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.
- Exclusion Criteria: The below exclusion criteria were applied only on the affected hand that were enrolled to the study
- History of previous carpal tunnel release.
- Receiving steroid injections for the treatment of CTS
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- History of infection or severe inflammation on the wrist
- Contraindications for focused ESWT, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer.
- Participants who refused or requested withdrawal from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Focused Shockwave Therapy in Patients With Moderate to Severe Carpal Tunnel Syndrome, a Single-blinded Randomized Controlled Trial
Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. In more severe case, patients may have difficult manipulating objects that disturb function and patient's quality of life. Extracorporeal Shockwave Therapy (ESWT) is one of physical modalities that uses to treat many musculoskeletal disorders. For CTS, previous evidence showed that ESWT can improve symptoms, function as well as electrophysiologic parameters. However, standardized guidelines as well as the study in patients with moderate to severe CTS has not been established. Thus, the objective of the present study was to evaluate efficacy of ESWT in term of symptoms, function, electrophysiologic parameters, as well as sonography of median nerve in patients with moderate to severe CTS.
Read the detailed description
- The present study was a single-blinded randomized controlled trial comparing the efficacy of focused ESWT (F-ESWT) to conservative treatment in patients with CTS.
- 24 patients who was diagnosed as CTS based on symptoms of CTS and physical examination. They were randomly allocated into two groups (21 patients per group), mainly F-ESWT plus conservative treatment and conservative treatment only.
- Outcome measures were BCTQ including symptom and function subscales, electrophysiologic parameters, and sonography to evaluate cross-sectional area (CSA) of the median nerve. All measures were recorded at baseline, 3 weeks and 6 weeks of treatment.
- Statistical analysis was performed to determine changes within the same group and compare difference between the two groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Focused ESWT, Control
- Keywords
- Carpal Tunnel Syndrome, ESWT, shockwave therapy
- 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.
Focused ESWTDevice
Also called F-ESWT
F-ESWT (dose 0.01-0.15 mJ/mm2, frequency 4-5 Hz, 1500 shocks) was applied perpendicular to the palmar side of the wrist which was done once a week for a total of three sessions plus conservative treatment.
ControlBehavioural
Participants in the control group received only conservative treatment including disease education, advice about proper posture and activity, night wrist splint and nerve gliding exercise.
| Study group | Role | What they receive |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy (F-ESWT) | Experimental | Participants in the intervention group received low-intensity F-ESWT once a week for three sessions plus conservative treatment. Receives: Device: Focused ESWT |
| Control | Active comparator | Participants in the control group received only conservative treatment including disease education, advice about proper posture and activity, night wrist splint and nerve gliding exercise. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)
T-BCTQ was used to assess symptom severity and hand function in patients with CTS. This questionnaire consists of two parts, mainly BCTQ symptom severity (BCTQs) and BCTQ functional status (BCTQf). Total questions for each part were 11 and 8 questions, respectively with scores raging from 1-5.
Measured: BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.
Secondary outcomes (5)
Electrodiagnostic parameters: Distal Sensory Latency (DSL)
DSL was evaluated using Cadwell Sierra Summit model IEC601-1.
Measured: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Distal Motor Latency (DML)
DML was evaluated using Cadwell Sierra Summit model IEC601-1.
Measured: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude
Sensory nerve action potential (SNAP) amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.
Measured: SNAP amplitude was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude
CMAP amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.
Measured: Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Total area under curve (TAUC)
TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.
Measured: Changes of TAUC was assessed from baseline to at 6 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jun 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punpetch Siriratna, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253729
- Sponsor's protocol ID
- MURA 2017/708
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Focused Shockwave Therapy in Patients With Moderate to Severe Carpal Tunnel Syndrome, a Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05253729
- Acronym / sponsor ID
- MURA 2017/708
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, ESWT, shockwave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 24 Feb 2022 (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.
Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. In more severe case, patients may have difficult manipulating objects that disturb function and patient's quality of life. Extracorporeal Shockwave Therapy (ESWT) is one of physical modalities that uses to treat many musculoskeletal disorders. For CTS, previous evidence showed that ESWT can improve symptoms, function as well as electrophysiologic parameters. However, standardized guidelines as well as the study in patients with moderate to severe CTS has not been established. Thus, the objective of the present study was to evaluate efficacy of ESWT in term of symptoms, function, electrophysiologic parameters, as well as sonography of median nerve in patients with moderate to severe CTS.
Detailed description
- The present study was a single-blinded randomized controlled trial comparing the efficacy of focused ESWT (F-ESWT) to conservative treatment in patients with CTS.
- 24 patients who was diagnosed as CTS based on symptoms of CTS and physical examination. They were randomly allocated into two groups (21 patients per group), mainly F-ESWT plus conservative treatment and conservative treatment only.
- Outcome measures were BCTQ including symptom and function subscales, electrophysiologic parameters, and sonography to evaluate cross-sectional area (CSA) of the median nerve. All measures were recorded at baseline, 3 weeks and 6 weeks of treatment.
- Statistical analysis was performed to determine changes within the same group and compare difference between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy (F-ESWT) | Experimental | Device: Focused ESWTParticipants in the intervention group received low-intensity F-ESWT once a week for three sessions plus conservative treatment. |
| Control | Active comparator | Behavioral: ControlParticipants in the control group received only conservative treatment including disease education, advice about proper posture and activity, night wrist splint and nerve gliding exercise. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants who were diagnosed as CTS based on the American Academy of neurology
- Participants who have electrodiagnostic evidence of CTS according to American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) guidelines for diagnosis of CTS. The severity of median nerve compression at wrist was moderate to severe degree.
- Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.
- Exclusion Criteria: The below exclusion criteria were applied only on the affected hand that were enrolled to the study
- History of previous carpal tunnel release.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Focused ESWTAlso: F-ESWTF-ESWT (dose 0.01-0.15 mJ/mm2, frequency 4-5 Hz, 1500 shocks) was applied perpendicular to the palmar side of the wrist which was done once a week for a total of three sessions plus conservative treatment. | Device | Focused Extracorporeal Shock Wave Therapy (F-ESWT) |
| ControlParticipants in the control group received only conservative treatment including disease education, advice about proper posture and activity, night wrist splint and nerve gliding exercise. | Behavioural | Control |
Primary outcome
Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)
Time frame: BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.
T-BCTQ was used to assess symptom severity and hand function in patients with CTS. This questionnaire consists of two parts, mainly BCTQ symptom severity (BCTQs) and BCTQ functional status (BCTQf). Total questions for each part were 11 and 8 questions, respectively with scores raging from 1-5.
5 secondary outcomes
Electrodiagnostic parameters: Distal Sensory Latency (DSL)
Time frame: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Distal Motor Latency (DML)
Time frame: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude
Time frame: SNAP amplitude was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude
Time frame: Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.
Electrodiagnostic parameters: Total area under curve (TAUC)
Time frame: Changes of TAUC was assessed from baseline to at 6 weeks of 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 24 Feb 2022.
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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.
Punpetch Siriratna, MD principal investigator
Ramathibodi 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 Focused ESWT in people with Carpal Tunnel Syndrome, run by Mahidol University at 1 site in Thailand.
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 9 inclusion and 0 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 24 Feb 2022. 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 Thailand. 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?
Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ) (time frame: BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.). 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 24 Feb 2022.