NCT07252960

Brief Summary

Carpal tunnel syndrome (CTS) is a common entrapment neuropathy that causes pain, paresthesia and functional limitations in the hand and wrist. Hydrotherapy methods such as warm whirlpool baths are frequently used in physiotherapy practice to reduce pain and improve soft-tissue properties, but their acute effects on forearm and hand muscle stiffness in CTS have not been clearly quantified. This randomized controlled trial aims to investigate the acute effects of a single session of warm whirlpool bath therapy on forearm and hand muscle stiffness and pain intensity in adults with CTS. Participants diagnosed with CTS will be randomly allocated to an experimental group receiving a 20-minute warm whirlpool bath or to a resting control group. Muscle stiffness of selected forearm and hand muscles will be assessed using the MyotonPRO device, and pain intensity will be recorded with a numeric rating scale, immediately before and after the intervention. It is hypothesized that warm whirlpool bath therapy will produce a greater reduction in muscle stiffness and pain compared with rest alone.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

10 days

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Carpal tunnel syndromeMuscle stiffnessWhirlpool bath therapy

Outcome Measures

Primary Outcomes (1)

  • Primary

    Dynamic muscle stiffness (N/m) of selected muscles on the affected upper limb (abductor pollicis brevis, flexor digitorum superficialis, extensor carpi radialis brevis, flexor carpi ulnaris) measured with the MyotonPRO device. For each muscle, three consecutive measurements will be recorded and the mean value will be used for analysis. The primary outcome is the change in stiffness from baseline to post-intervention, compared between the warm whirlpool bath group and the resting control group. Higher values indicate greater muscle stiffness.

    Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)

Secondary Outcomes (1)

  • Change in Pain Intensity in the Affected Hand/Wrist

    Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)

Study Arms (2)

Warm Whirlpool Bath Therapy

EXPERIMENTAL

Participants receive a single session of warm whirlpool bath therapy applied to the affected forearm and hand for 20 minutes.

Procedure: Warm Whirlpool Bath TherapyOther: Resting Control Condition

Resting Control

ACTIVE COMPARATOR

Participants rest in a comfortable supported position for 20 minutes without whirlpool or thermal intervention.

Procedure: Warm Whirlpool Bath TherapyOther: Resting Control Condition

Interventions

The affected hand and forearm are immersed in a therapeutic whirlpool bath with gently circulating water at approximately 38-39°C for 20 minutes. Participants are positioned to ensure comfort and muscle relaxation. Skin integrity and tolerance to heat are checked before treatment and monitored throughout the session

Resting ControlWarm Whirlpool Bath Therapy

Participants rest in a comfortable supine or seated position with the affected forearm supported for 20 minutes. No active hydrotherapy, thermal or manual intervention is applied. Positioning and monitoring are comparable to the experimental group.

Resting ControlWarm Whirlpool Bath Therapy

Eligibility Criteria

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

You may qualify if:

  • Being apparently healthy without a known chronic systemic disease
  • Physically active participants, regardless of gender
  • Adults aged 18-65 years diagnosed with carpal tunnel syndrome
  • No history of other chronic musculoskeletal or neurological disorders
  • Not having any acute upper limb injury

You may not qualify if:

  • Having a previous surgery on the affected wrist or hand
  • Systemic conditions affecting nerve function, such as diabetes mellitus or thyroid disease
  • Having a cardiovascular disease or uncontrolled hypertension
  • Being younger than 18 or older than 65 years
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Şehir Hastanesi

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gökhan YAĞIZ

    Amasya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esedullah AKARAS, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, neither participants nor treating therapists are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-group randomized controlled trial with a 1:1 allocation ratio to warm whirlpool bath therapy or resting control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

November 30, 2025

Primary Completion

December 10, 2025

Study Completion

December 10, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. This is a single-center study with a relatively small sample size and a specific clinical population, which increases the risk of indirect re-identification even after de-identification. In addition, the current ethical approval and informed consent procedures do not explicitly cover external data sharing, and the study team has limited resources to support and monitor secondary data use. Aggregate results (e.g., group means and standard deviations) will be reported in scientific publications and presentations.

Locations