NCT06977321

Brief Summary

Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who received a total of 6 sessions of kinesiotaping twice a week along with a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

First Submitted

Initial submission to the registry

May 9, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

May 17, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

March 20, 2026

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

May 9, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

carpal tunnel syndrome (CTS)Peloidotherapyexercisepainkinesio tapingultrasound

Outcome Measures

Primary Outcomes (2)

  • VAS pain

    A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.

    baseline, week 3 and week 12

  • The Boston Carpal Tunnel Syndrome Questionnaire

    The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.

    baseline, week 3 and week 12

Secondary Outcomes (4)

  • Hand grip strength

    baseline, week 3 and week 12

  • Finger pinch strength

    baseline, week 3 and week 12

  • Ultrasonographic evaluation of the median nerve

    baseline, week 3 and week 12

  • Douleur Neuropathique 4

    baseline, week 3 and week 12

Study Arms (3)

Kinesiotaping

EXPERIMENTAL

This group will be given a home exercise program along with a total of 6 sessions of kinesiotaping twice a week.

Other: KinesiotapingOther: Home exercise

Peloidotherapy

EXPERIMENTAL

This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.

Other: PeloidotherapyOther: Home exercise

Home exercise

EXPERIMENTAL

This group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.

Other: Home exercise

Interventions

Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.

Home exerciseKinesiotapingPeloidotherapy

Kinesiotaping, unlike wrist splints, which are frequently used in the treatment of carpal tunnel syndrome, does not restrict daily living activities. Space correction technique will be applied while performing kinesio taping.

Kinesiotaping

Peloidotherapy stands out among superficial heating physical therapy modalities with its mineral and natural origin.

Peloidotherapy

Eligibility Criteria

Age18 Months - 65 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 18-65
  • Agreeing to participate voluntarily in the study
  • Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study

You may not qualify if:

  • Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
  • Being diagnosed with severe CTS
  • Having a history of previous wrist surgery or trauma
  • Having atrophy in the thenar region or weakness in the thenar muscles
  • Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
  • Having had steroid injections in the last 3 months and taking oral steroid medications
  • Being pregnant
  • Having an open wound or rash in the wrist and its surroundings that would prevent treatment
  • Patients who are receiving or will receive another/additional treatment for CTS
  • Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, 42060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel SyndromeMotor ActivityAgnosiaPain

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesBehaviorPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ayşe Güleç, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-blind, randomized, prospective
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 18, 2025

Study Start

May 17, 2025

Primary Completion

April 15, 2026

Study Completion

May 15, 2026

Last Updated

March 20, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations