Efficacy of Focused Shockwave Therapy in Patients With CTS

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Focused ESWT; Behavioral: Control

• Registration Number: NCT05253729
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Study First Submitted: 2022-01-24
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-24
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

The below exclusion criteria were applied only on the affected hand that were enrolled to the study

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused Extracorporeal Shock Wave Therapy (F-ESWT)	Focused ESWT	Participants in the intervention group received low-intensity F-ESWT once a week for three sessions plus conservative treatment.
Control	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.

Primary Outcome Measures

Name	Time	Method
Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)	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.

Secondary Outcome Measures

Name	Time	Method
Electrodiagnostic parameters: Distal Sensory Latency (DSL)	Changes of DSL was assessed from baseline to at 6 weeks of treatment.	DSL was evaluated using Cadwell Sierra Summit model IEC601-1.
Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude	SNAP amplitude was assessed from baseline to at 6 weeks of treatment.	Sensory nerve action potential (SNAP) amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.
Electrodiagnostic parameters: Distal Motor Latency (DML)	Changes of DSL was assessed from baseline to at 6 weeks of treatment.	DML was evaluated using Cadwell Sierra Summit model IEC601-1.
Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude	Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.	CMAP amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.
Electrodiagnostic parameters: Total area under curve (TAUC)	Changes of TAUC was assessed from baseline to at 6 weeks of treatment.	TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.

Trial Locations

Locations (1)

Punpetch Siriratna; 🇹🇭 Bangkok, Thailand