NCT07260448

Brief Summary

This randomized controlled trial aims to investigate the immediate effects of paraffin wax therapy on muscle stiffness and pain among patients diagnosed with Carpal Tunnel Syndrome (CTS). The intervention involves immersing the hand and forearm in paraffin wax at 42-44 °C for 20 minutes. Stiffness will be measured using the MyotonPro device, and pain will be evaluated using standard visual scales.

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

10 days

First QC Date

November 19, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in muscle stiffness parameters

    Change in MyotonPro-derived muscle stiffness (Newton per metre) of selected forearm and hand muscles (adductor pollicis brevis, flexor digitorum superficialis, extensor carpi radialis brevis, flexor carpi ulnaris ). For each site, three consecutive impulses separated by at least 10 seconds will be averaged. The primary comparison is the between-group difference (paraffin vs rest) in pre- to post-session change scores.

    Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit)

Secondary Outcomes (1)

  • Change in pain intensity

    Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit).

Study Arms (2)

Paraffin Wax Therapy

EXPERIMENTAL

Participants receive a single session of paraffin wax therapy to the affected hand and forearm. Muscle stiffness and pain are assessed immediately before and after the session.

Other: Paraffin Wax TherapyOther: Rest Period (No Treatment)

Rest / Control

OTHER

Participants rest quietly for 20 minutes in a comfortable position with the forearm supported, without receiving paraffin wax or any other physical/thermal modality. Muscle stiffness and pain are assessed at the same time points as in the experimental arm.

Other: Paraffin Wax TherapyOther: Rest Period (No Treatment)

Interventions

Participants in the experimental arm receive paraffin wax therapy to the affected hand and forearm. Melted paraffin is maintained at approximately 42-44 °C. Using a brush-on technique, 10 consecutive layers of wax are applied, and the limb is then covered with a plastic glove and towel to retain heat. The participant remains seated with the forearm supported in a relaxed position for 20 minutes. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the session.

Paraffin Wax TherapyRest / Control

Participants in the control arm rest quietly for 20 minutes in a comfortable seated or supine position with the forearm supported. No thermal, manual or exercise-based treatment is provided during this period. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the rest period, using the same procedures and time points as in the experimental arm.

Paraffin Wax TherapyRest / Control

Eligibility Criteria

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

You may qualify if:

  • Clinically diagnosed carpal tunnel syndrome.
  • Age between 18 and 65 years.
  • Apparently healthy, without a known chronic systemic disease (other than CTS).
  • No history of other chronic musculoskeletal or neurological disorders.

You may not qualify if:

  • Previous surgery on the affected wrist or hand.
  • Systemic conditions affecting nerve function (e.g., diabetes mellitus, thyroid disease)
  • Cardiovascular disease or uncontrolled hypertension.

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

Central Study Contacts

Esedullah Akaras, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with carpal tunnel syndrome will be randomly assigned (1:1) to paraffin wax therapy or a control group; muscle stiffness and pain will be assessed immediately before and after the session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 3, 2025

Study Start

November 25, 2025

Primary Completion

December 5, 2025

Study Completion

December 6, 2025

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) from this trial. Summary results and aggregate data will be disseminated through peer-reviewed publications and conference presentations.

Locations