Efficacy of Focused Shockwave Therapy in Patients With CTS

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253729
• Other study ID #: MURA 2017/708
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Thailand	Punpetch Siriratna	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Median nerve cross-sectional area (CSA) at wrist level	Median nerve CSA at wrist (pisiform level) was assessed by ultrasonography.	Changes of median nerve CSA at wrist were assessed from baseline to at 6 weeks of treatment.
Other	Median nerve cross-sectional area (CSA); wrist to forearm ratio	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.	Median nerve CSA (wrist to forearm ratio) were assessed changes from baseline to at 6 weeks of treatment.
Primary	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.	BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.
Secondary	Electrodiagnostic parameters: Distal Sensory Latency (DSL)	DSL was evaluated using Cadwell Sierra Summit model IEC601-1.	Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Secondary	Electrodiagnostic parameters: Distal Motor Latency (DML)	DML was evaluated using Cadwell Sierra Summit model IEC601-1.	Changes of DSL was assessed from baseline to at 6 weeks of treatment.
Secondary	Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude	Sensory nerve action potential (SNAP) amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.	SNAP amplitude was assessed from baseline to at 6 weeks of treatment.
Secondary	Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude	CMAP amplitude was evaluated using Cadwell Sierra Summit model IEC601-1.	Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.
Secondary	Electrodiagnostic parameters: Total area under curve (TAUC)	TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.	Changes of TAUC was assessed from baseline to at 6 weeks of treatment.