Carpal Tunnel SyndromeCTS-WBNCT07252960
Acute Effects of Warm Whirlpool Bath Therapy on Forearm and Hand Muscle Stiffness and Pain in Carpal Tunnel Syndrome
A study testing Warm Whirlpool Bath Therapy in people with Carpal Tunnel Syndrome, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Warm Whirlpool Bath Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum Şehir Hastanesi
Erzurum
Aliekber TAYFUN, Dr., +90 ( 442 ) 432 10 00 ext. 2859, aliekbertayfun@gmail.com
About this study
Official title: Acute Effects of Warm Whirlpool Bath Therapy on Forearm and Hand Muscle Stiffness and Pain in Patients With Carpal Tunnel Syndrome: A Randomised Controlled Trial
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.
Read the detailed description
Carpal tunnel syndrome (CTS) is one of the most prevalent peripheral entrapment neuropathies and is characterized by pain, numbness and tingling in the hand, weakness of thenar muscles and impairments in hand function. In addition to nerve compression, changes in the mechanical properties of muscles and tendons surrounding the wrist and hand may contribute to symptoms, altered biomechanics and functional limitations in individuals with CTS. Increased muscle stiffness can restrict motion, impair force transmission and exacerbate pain, whereas excessive reductions in stiffness may compromise joint stability and fine motor control. Therefore, non-invasive interventions that can modulate muscle stiffness and relieve pain are of considerable interest in the management of CTS.
Warm whirlpool bath therapy is a traditional hydrotherapy modality that combines thermal and mild mechanical stimulation through circulating water. The convective heat may enhance local blood flow, reduce muscle spasm and alter viscoelastic properties of soft tissues, while water movement provides gentle massage-like effects. Although whirlpool baths are widely used in physiotherapy and rehabilitation practice, there is limited objective evidence regarding their acute effects on muscle mechanical properties in patients with CTS. Advances in handheld myotonometry devices, such as the MyotonPRO, allow non-invasive, reliable quantification of muscle stiffness, tone and elasticity and provide an opportunity to evaluate treatment effects beyond subjective palpation and self-reported outcomes.
This single-center, parallel-group randomized controlled trial will be conducted in a university physiotherapy and rehabilitation clinic. Physically active adults aged 18-65 years with a clinical diagnosis of carpal tunnel syndrome will be screened according to predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned in a 1:1 ratio to either the warm whirlpool bath group or the resting control group. All assessments and interventions will be carried out on the affected upper limb.
In the experimental group, the affected hand and forearm will be immersed in a therapeutic whirlpool bath with gently circulating water at approximately 38-39°C for 20 minutes. Participants will be positioned to ensure comfort and muscle relaxation, and skin integrity and tolerance to heat will be monitored throughout the session. In the control group, participants will rest in a comparable position with the affected forearm supported for the same duration (20 minutes) without any active hydrotherapy or thermal intervention.
Outcome measures will be obtained immediately before and after the single intervention session. The primary outcomes are dynamic stiffness (N/m) of selected muscles of the forearm and hand (e.g., abductor pollicis brevis, flexor digitorum superficialis, extensor carpi radialis brevis, flexor carpi ulnaris) measured using the MyotonPRO device, and pain intensity at the wrist/hand assessed with a 0-10 numeric rating scale. Secondary outcomes may include additional MyotonPRO parameters such as muscle tone (frequency) and elasticity (logarithmic decrement). The main analysis will compare pre- to post-intervention changes between the whirlpool and control groups.
The overarching aim of this study is to provide objective, quantitative data on the acute effects of warm whirlpool bath therapy on muscle mechanical properties and pain in patients with CTS. Demonstrating a beneficial effect on muscle stiffness and pain may support the use of this simple, low-cost and non-pharmacological modality as part of comprehensive rehabilitation programs for carpal tunnel syndrome and inform future research on longer-term interventions and functional outcomes.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Warm Whirlpool Bath Therapy, Resting Control Condition
- Keywords
- Carpal tunnel syndrome, Muscle stiffness, Whirlpool bath therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Whirlpool Bath TherapyProcedure or surgery
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 Control ConditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Warm Whirlpool Bath Therapy; Other: Resting Control Condition |
| Resting Control | Active comparator | Participants rest in a comfortable supported position for 20 minutes without whirlpool or thermal intervention. Receives: Procedure: Warm Whirlpool Bath Therapy; Other: Resting Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Patient-reported pain intensity at the affected hand/wrist assessed using a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain). The primary outcome is the change in pain score from baseline to post-intervention, compared between the warm whirlpool bath group and the resting control group. A decrease in score indicates pain reduction.
Measured: Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group randomized controlled trial with a 1:1 allocation ratio to warm whirlpool bath therapy or resting control.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University, Bangor University
- Responsible party
- Principal investigator, esedullah akaras, Erzurum Technical University
- Investigators
- Gökhan YAĞIZ, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252960
- Sponsor's protocol ID
- ETU-CTS-WB-2025-01
- Acronym
- CTS-WB
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Warm Whirlpool Bath Therapy on Forearm and Hand Muscle Stiffness and Pain in Patients With Carpal Tunnel Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07252960
- Acronym / sponsor ID
- CTS-WB / ETU-CTS-WB-2025-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Muscle stiffness, Whirlpool bath therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Collaborators
- Amasya University, Bangor University
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Carpal tunnel syndrome (CTS) is one of the most prevalent peripheral entrapment neuropathies and is characterized by pain, numbness and tingling in the hand, weakness of thenar muscles and impairments in hand function. In addition to nerve compression, changes in the mechanical properties of muscles and tendons surrounding the wrist and hand may contribute to symptoms, altered biomechanics and functional limitations in individuals with CTS. Increased muscle stiffness can restrict motion, impair force transmission and exacerbate pain, whereas excessive reductions in stiffness may compromise joint stability and fine motor control. Therefore, non-invasive interventions that can modulate muscle stiffness and relieve pain are of considerable interest in the management of CTS.
Warm whirlpool bath therapy is a traditional hydrotherapy modality that combines thermal and mild mechanical stimulation through circulating water. The convective heat may enhance local blood flow, reduce muscle spasm and alter viscoelastic properties of soft tissues, while water movement provides gentle massage-like effects. Although whirlpool baths are widely used in physiotherapy and rehabilitation practice, there is limited objective evidence regarding their acute effects on muscle mechanical properties in patients with CTS. Advances in handheld myotonometry devices, such as the MyotonPRO, allow non-invasive, reliable quantification of muscle stiffness, tone and elasticity and provide an opportunity to evaluate treatment effects beyond subjective palpation and self-reported outcomes.
This single-center, parallel-group randomized controlled trial will be conducted in a university physiotherapy and rehabilitation clinic. Physically active adults aged 18-65 years with a clinical diagnosis of carpal tunnel syndrome will be screened according to predefined inclusion and exclusion criteria. Eligible participants will be randomly assigned in a 1:1 ratio to either the warm whirlpool bath group or the resting control group. All assessments and interventions will be carried out on the affected upper limb.
In the experimental group, the affected hand and forearm will be immersed in a therapeutic whirlpool bath with gently circulating water at approximately 38-39°C for 20 minutes. Participants will be positioned to ensure comfort and muscle relaxation, and skin integrity and tolerance to heat will be monitored throughout the session. In the control group, participants will rest in a comparable position with the affected forearm supported for the same duration (20 minutes) without any active hydrotherapy or thermal intervention.
Outcome measures will be obtained immediately before and after the single intervention session. The primary outcomes are dynamic stiffness (N/m) of selected muscles of the forearm and hand (e.g., abductor pollicis brevis, flexor digitorum superficialis, extensor carpi radialis brevis, flexor carpi ulnaris) measured using the MyotonPRO device, and pain intensity at the wrist/hand assessed with a 0-10 numeric rating scale. Secondary outcomes may include additional MyotonPRO parameters such as muscle tone (frequency) and elasticity (logarithmic decrement). The main analysis will compare pre- to post-intervention changes between the whirlpool and control groups.
The overarching aim of this study is to provide objective, quantitative data on the acute effects of warm whirlpool bath therapy on muscle mechanical properties and pain in patients with CTS. Demonstrating a beneficial effect on muscle stiffness and pain may support the use of this simple, low-cost and non-pharmacological modality as part of comprehensive rehabilitation programs for carpal tunnel syndrome and inform future research on longer-term interventions and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial with a 1:1 allocation ratio to warm whirlpool bath therapy or resting control.
| Arm | Type | Receives |
|---|---|---|
| Warm Whirlpool Bath Therapy | Experimental | Procedure: Warm Whirlpool Bath Therapy, Other: Resting Control ConditionParticipants receive a single session of warm whirlpool bath therapy applied to the affected forearm and hand for 20 minutes. |
| Resting Control | Active comparator | Procedure: Warm Whirlpool Bath Therapy, Other: Resting Control ConditionParticipants rest in a comfortable supported position for 20 minutes without whirlpool or thermal intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Whirlpool Bath TherapyThe 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 | Procedure or surgery | Resting Control, Warm Whirlpool Bath Therapy |
| Resting Control ConditionParticipants 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. | Other | Resting Control, Warm Whirlpool Bath Therapy |
Primary outcome
Primary
Time frame: Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)
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.
1 secondary outcome
Change in Pain Intensity in the Affected Hand/Wrist
Time frame: Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gökhan YAĞIZ principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Whirlpool Bath Therapy in people with Carpal Tunnel Syndrome, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esedullah AKARAS, Dr. (4445388 ext. 2772, esedullah.akaras@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: Baseline (pre-intervention) and immediately after the single 20-minute session (within approximately 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.