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Completed

NCT Number: NCT05253729

Efficacy of Focused Shockwave Therapy in Patients With CTS

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Punpetch Siriratna

Bangkok, 10400, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

  • 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.

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)

    Time frame: 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 outcomes

  1. Electrodiagnostic parameters: Distal Sensory Latency (DSL)

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

    DSL was evaluated using Cadwell Sierra Summit model IEC601-1.

  2. Electrodiagnostic parameters: Distal Motor Latency (DML)

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

    DML was evaluated using Cadwell Sierra Summit model IEC601-1.

  3. Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude

    Time frame: 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.

  4. Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude

    Time frame: 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.

  5. Electrodiagnostic parameters: Total area under curve (TAUC)

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

    TAUC was evalauted using Cadwell Sierra Summit model IEC601-1.

Other outcomes

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

    Time frame: Changes of median nerve CSA at wrist were assessed from baseline to at 6 weeks of treatment.

    Median nerve CSA at wrist (pisiform level) was assessed by ultrasonography.

  2. Median nerve cross-sectional area (CSA); wrist to forearm ratio

    Time frame: Median nerve CSA (wrist to forearm ratio) were assessed changes from baseline to at 6 weeks of treatment.

    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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2022
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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