Efficacy of Focused Shockwave Therapy in Patients With CTS

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Focused ESWT; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Punpetch Siriratna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: F-ESWT
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Punpetch Siriratna, MD, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (ACTUAL): February 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome, ESWT, shockwave therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: MURA 2017/708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No