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Efficacy of Focused Shockwave Therapy in Patients With CTS

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Focused ESWT

Control

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, ESWT, shockwave therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Sites / Locations

Punpetch Siriratna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Focused Extracorporeal Shock Wave Therapy (F-ESWT)

Control

Arm Description

Participants in the intervention group received low-intensity F-ESWT once a week for three sessions plus conservative treatment.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Electrodiagnostic parameters: Distal Sensory Latency (DSL)

DSL was evaluated using Cadwell Sierra Summit model IEC601-1.

Electrodiagnostic parameters: Distal Motor Latency (DML)

DML was evaluated using Cadwell Sierra Summit model IEC601-1.

Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude

Sensory nerve action potential (SNAP) amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.

Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude

CMAP amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.

Electrodiagnostic parameters: Total area under curve (TAUC)

TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.

Full Information

NCT ID

NCT05253729

First Posted

January 24, 2022

Last Updated

February 14, 2022

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT05253729

Brief Title

Efficacy of Focused Shockwave Therapy in Patients With CTS

Official Title

Efficacy of Focused Shockwave Therapy in Patients With Moderate to Severe Carpal Tunnel Syndrome, a Single-blinded Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, ESWT, shockwave therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focused Extracorporeal Shock Wave Therapy (F-ESWT)

Arm Type

Experimental

Arm Description

Participants in the intervention group received low-intensity F-ESWT once a week for three sessions plus conservative treatment.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Focused ESWT

Other Intervention Name(s)

F-ESWT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)

Description

Time Frame

BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.

Secondary Outcome Measure Information:

Title

Electrodiagnostic parameters: Distal Sensory Latency (DSL)

Description

DSL was evaluated using Cadwell Sierra Summit model IEC601-1.

Time Frame

Changes of DSL was assessed from baseline to at 6 weeks of treatment.

Title

Electrodiagnostic parameters: Distal Motor Latency (DML)

Description

DML was evaluated using Cadwell Sierra Summit model IEC601-1.

Time Frame

Changes of DSL was assessed from baseline to at 6 weeks of treatment.

Title

Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude

Description

Sensory nerve action potential (SNAP) amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.

Time Frame

SNAP amplitude was assessed from baseline to at 6 weeks of treatment.

Title

Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude

Description

CMAP amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.

Time Frame

Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.

Title

Electrodiagnostic parameters: Total area under curve (TAUC)

Description

TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.

Time Frame

Changes of TAUC was assessed from baseline to at 6 weeks of treatment.

Other Pre-specified Outcome Measures:

Title

Median nerve cross-sectional area (CSA) at wrist level

Description

Median nerve CSA at wrist (pisiform level) was assessed by ultrasonography.

Time Frame

Changes of median nerve CSA at wrist were assessed from baseline to at 6 weeks of treatment.

Title

Median nerve cross-sectional area (CSA); wrist to forearm ratio

Description

Median nerve CSA was assessed by ultrasonography in two levels, mainly at pisiform level and at the level of pronator quadratus muscle. CSA were then determined for wrist to forearm ratio.

Time Frame

Median nerve CSA (wrist to forearm ratio) were assessed changes from baseline to at 6 weeks of treatment.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Punpetch Siriratna, MD

Organizational Affiliation

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Punpetch Siriratna

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

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Efficacy of Focused Shockwave Therapy in Patients With CTS

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