NCT05314777

Brief Summary

The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

March 29, 2022

Last Update Submit

May 30, 2022

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromeExtracorporeal Shockwave TherapyMedian Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Boston Carpal Tunnel Syndrome Questionnaire

    The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.

    First month- Third month

Secondary Outcomes (4)

  • Hand Grip Force

    First month- Third month

  • Nerve Conduction Velocity

    First month- Third month

  • Short Form- 36

    First month- Third month

  • Visual analog scale

    First month- Third month

Study Arms (3)

Low dose ESWT application group

EXPERIMENTAL

Exercise Training Low dose ESWT application

Procedure: Low dose ESWT applicationProcedure: Exercise Training

High dose ESWT group

EXPERIMENTAL

Exercise Training High dose ESWT application

Procedure: High dose ESWT applicationProcedure: Exercise Training

Control group

ACTIVE COMPARATOR

Exercise Training Sham ESWT

Procedure: Sham ESWTProcedure: Exercise Training

Interventions

Low dose ESWT applicationPROCEDURE

Patients trained for low dose ESWT application.

Low dose ESWT application group
High dose ESWT applicationPROCEDURE

Patients trained for high dose ESWT application.

High dose ESWT group
Sham ESWTPROCEDURE

Patients trained for sham ESWT.

Control group
Exercise TrainingPROCEDURE

Patients trained for exercise training.

Control groupHigh dose ESWT groupLow dose ESWT application group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65,
  • Clinical symptoms persisting for at least 3 months
  • Pain, tingling and paresthesia in the first 3 fingers together with the Phalen and Tinel test makes the patient positive,
  • Patients who are positive are evaluated by a specialist in electrodiagnostic testing and the clinical stage of CTS is determined.
  • Mild to moderate CTS is diagnosed if the sensory nerve action potential (SNAP) is \>6 μV and the combined muscle action potential (CMAP) is \>2.1 mV.
  • Being diagnosed with mild and moderate CTS

You may not qualify if:

  • The patient who received CTS operation or corticosteroid treatment,
  • Presence of systemic diseases that will affect our treatment such as diabetes, rheumatoid arthritis, gout,
  • It has been determined as atrophy in the thenar region of the hand (Xu,2020).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, 34488, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yasemin Karaaslan, Ph.D.

    Beykent University

    PRINCIPAL INVESTIGATOR

  • Fatih Ozyurt, Pt

    Beykent University

    STUDY CHAIR

Central Study Contacts

Yasemin Karaaslan, Ph.D.

CONTACT

05358459625ptyasemindeveci@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Pt.

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

May 30, 2022

Primary Completion

August 20, 2022

Study Completion

December 20, 2022

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

TU(1)