NCT07167667

Brief Summary

The study plans to include a total of 60 patients diagnosed with carpal tunnel syndrome. Patients will be divided into two groups according to the treatment they receive. One group will receive only paraffin treatment, while the other group will receive only ESWT treatment. ESWT will be applied for a total of 5 sessions. Paraffin will be applied for a total of 10 sessions. As assessment tools;

  • Measurement of median nerve thickness with ultrasound
  • Electromyography
  • Visual Analog Scale
  • Short Form-36 Evaluations will be made twice by a specialist physician before and after the treatments.

Trial Health

57
Monitor

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 Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

October 25, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

June 11, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Median Nerve ThicknessUltrasoundElectromyograpyPhysiotherapyESWTParaffin

Outcome Measures

Primary Outcomes (2)

  • Median Nerve Thickness

    Median nerve thickness will be measured by ultrasound

    Baseline

  • Median Nerve Thickness

    Median nerve thickness will be measured by ultrasound

    5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention

Secondary Outcomes (5)

  • Electromyography

    Baseline

  • Visual Analog Scale

    Baseline

  • Visual Analog Scale

    5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention

  • Short Form-36

    Baseline

  • Short Form-36

    5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention

Study Arms (2)

Paraffin

EXPERIMENTAL
Other: Paraffin Bath

ESWT

EXPERIMENTAL
Other: Extracorporeal Shock Wave Therapy

Interventions

Patients' hands will be dipped into the paraffin bath 8-10 times.

Paraffin

The patients will be treated with a sound wave pulse frequency of 15 Hz, an intensity of 1.5 bar, and a total number of pulses of 2000 for one session.

ESWT

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals between the ages of 30-60 who have been diagnosed with CTS by a specialist physician according to international criteria (Those between Stages 1-3),
  • Those who have complaints of numbness, tingling, and pain in the first three fingers and half of the fourth finger,
  • Phalen Test and Tinel sign or Durkan Test being positive
  • Patients who will receive 5 sessions of ESWT application prescribed by a Physical Medicine and Rehabilitation Specialist Physician (for the ESWT group)
  • Patients who have been recommended 10 sessions of Paraffin application by a Physical Medicine and Rehabilitation Specialist Physician (for the Paraffin group)

You may not qualify if:

  • Presence of atrophy in the thenar muscles,
  • Insufficient sensory and motor response in the median nerve,
  • History of hand and/or wrist injury or surgery,
  • Those with cervical stenosis, cervical spondylosis, or cervical radiculopathy,
  • Corticosteroids in the carpal tunnel area within the last six months those who have had an injection,
  • Pregnancy or diabetes, renal failure, rheumatoid arthritis or hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltalimani Metin Sabanci Bone Diseases Training and Research Hospita

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Esra Sonbahar Bolat, Physician

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2025

First Posted

September 11, 2025

Study Start

October 25, 2024

Primary Completion

October 25, 2025

Study Completion

October 25, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations