Efficacy of Focused Shockwave Therapy in Patients With CTS

NCT ID: NCT05253729

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-09-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Focused Extracorporeal Shock Wave Therapy (F-ESWT)

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

Group Type: EXPERIMENTAL

Focused ESWT

Intervention Type: DEVICE

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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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.

Interventions

Focused 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.

Intervention Type: DEVICE

Control

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: BEHAVIORAL

Other Intervention Names

F-ESWT

Eligibility Criteria

Inclusion Criteria

1. Participants who were diagnosed as CTS based on the American Academy of neurology

2. 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.

3. Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.

Exclusion Criteria

1. History of previous carpal tunnel release.

2. Receiving steroid injections for the treatment of CTS

3. History of infection or severe inflammation on the wrist

4. Contraindications for focused ESWT, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer.

5. Participants who refused or requested withdrawal from the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Punpetch Siriratna, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

Punpetch Siriratna

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

MURA 2017/708

Identifier Type: -

Identifier Source: org_study_id