Clinical trial NCT05253729: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome, ESWT, shockwave therapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: 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.

Primary outcomes:
measure: Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)
timeFrame: BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.
Secondary outcomes:
measure: Electrodiagnostic parameters: Distal Sensory Latency (DSL)
timeFrame: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
measure: Electrodiagnostic parameters: Distal Motor Latency (DML)
timeFrame: Changes of DSL was assessed from baseline to at 6 weeks of treatment.
measure: Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude
timeFrame: SNAP amplitude was assessed from baseline to at 6 weeks of treatment.
measure: Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude
timeFrame: Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.
measure: Electrodiagnostic parameters: Total area under curve (TAUC)
timeFrame: Changes of TAUC was assessed from baseline to at 6 weeks of treatment.
Other outcomes:
measure: Median nerve cross-sectional area (CSA) at wrist level
timeFrame: Changes of median nerve CSA at wrist were assessed from baseline to at 6 weeks of treatment.
measure: Median nerve cross-sectional area (CSA); wrist to forearm ratio
timeFrame: Median nerve CSA (wrist to forearm ratio) were assessed changes from baseline to at 6 weeks of treatment.
Locations:
city: Bangkok
country: Thailand
facility: Punpetch Siriratna
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Punpetch Siriratna, MD
role: PRINCIPAL_INVESTIGATOR
References: