Efficacy of Focused Shockwave Therapy in Patients With CTS

NCT05253729 | Completed

• 1 other identifier: MURA 2017/708
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, ESWT, shockwave therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Electrodiagnostic parameters: Distal Sensory Latency (DSL)

  Changes of DSL was assessed from baseline to at 6 weeks of treatment.

• Electrodiagnostic parameters: Distal Motor Latency (DML)

  Changes of DSL was assessed from baseline to at 6 weeks of treatment.

• Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude

  SNAP amplitude was assessed from baseline to at 6 weeks of treatment.

• Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude

  Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.

• Electrodiagnostic parameters: Total area under curve (TAUC)

  Changes of TAUC was assessed from baseline to at 6 weeks of treatment.

Other Outcomes (2)

• Median nerve cross-sectional area (CSA) at wrist level

  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 (wrist to forearm ratio) were assessed changes from baseline to at 6 weeks of treatment.

Study Arms (2)

Focused Extracorporeal Shock Wave Therapy (F-ESWT)

EXPERIMENTAL

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

Device: Focused ESWT

Control

ACTIVE COMPARATOR

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

Interventions

Focused ESWT 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.

Also known as: F-ESWT

Focused Extracorporeal Shock Wave Therapy (F-ESWT)

Control 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.

Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who were diagnosed as CTS based on the American Academy of neurology
• 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.
• Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.

You may not qualify if:

• History of previous carpal tunnel release.
• Receiving steroid injections for the treatment of CTS
• History of infection or severe inflammation on the wrist
• Contraindications for focused ESWT, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer.
• Participants who refused or requested withdrawal from the study.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Punpetch Siriratna

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Punpetch Siriratna, MD

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 24, 2022
• Study Start: June 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

TH (1)