Distal Radius FractureNCT06769373
The Effects of Whirlpool and Contrast Bath in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture
A study testing Whirlpool Bath and Contrast Bath in people with Distal Radius Fracture and Complex Regional Pain Syndrome Type I, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Distal Radius Fracture, Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome
- What is being tested?
- Whirlpool Bath and Contrast Bath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 15 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complex regional pain syndrome type-1 (CRPS-type 1) after distal radius fracture, who were followed conservatively (long/short arm splint-cast) between the ages of 18-70, who applied to AFSU Physical Medicine and Rehabilitation Clinic. It is planned to use the Budapest diagnostic criteria for the diagnosis of CRPS Type 1.
Who cannot join
- Orthopedic injuries (other accompanying orthopedic fractures, such as ulna fracture, carpal bone fractures),
- Other system injuries,
- Patients whose distal radius fractures were surgically treated,
- Patients who had previously undergone surgery on the same upper extremity,
- Nerve, tendon and artery injuries accompanying the fracture,
- Other neurological, orthopedic or rheumatological problems affecting the same upper extremity,
Show all 10Show fewer
- Serious cardiovascular disease,
- Presence of active infection, active dermatitis, skin diseases such as pemphigus, febrile diseases,
- Presence of a fixed catheter in the area,
- Impaired temperature sensationin in the area.
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, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, Afyonkarahisar, 03030
Ersin Beştaş, MD, +905068893266, ersinbestas26@gmail.com
Duygu Keskin, MD, +905077902716, keskiin01@hotmail.com
About this study
Official title: The Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture
The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture.
Read the detailed description
Distal radius fractures are the most common fracture type among all body bone fractures. Fractures generally occur in elderly patients caused by low-energy trauma due to decreased bone quality. In young patients, they mostly occur due to traumas such as traffic accidents, falls from heights and sports injuries.
One of the important complications seen after distal radius fractures is complex regional pain syndrome (CRPS). Complex regional pain syndrome represents a complication following distal radius fractures that is still not fully understood etiologically.
Studies have shown that complex regional pain syndrome is commonly diagnosed among patients recovering from a fracture of the distal radius with a reported incidence as high as 37%. It is characterized by excessive pain (allodynia and/or hyperalgesia), edema, local blood flow changes and abnormality of the sudomotor nerve.
There are hardly any studies with a sufficient evidence level to make recommendations for treatments for CRPS-1; therefore, treatment is based on symptom management. Prevention of CRPS-1, after a distal radius fracture is important as this syndrome might lead to chronic pain and serious disabilities. In several studies, it was shown that CRPS-1 can be cured with exercise and graded activities. The main goals of physiotherapy are to reduce pain, regain range of motion, and increase muscle strength and function.
Whirlpool bath and contrast bath treatments are physical therapy methods that has been used safely in complex regional pain syndrome treatment for many years.
Whirlpool baths are local baths where the extremities are immersed in rapidly circulating water. The swirling water produced by the whirlpool bath creates a massaging effect on the body, which can help relieve muscle tension and alleviate pain. The combination of warm water and hydrostatic pressure can also enhance blood circulation and improve joint mobility.
Contrast baths constitute a thermal modality whereby the hand is alternately immersed in hot and cold water for a specified temperature, time, and duration to therapeutically decrease edema, stiffness, pain and increase functionality in cases of complex regional pain syndrome after fractures.
Our primary aim is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients who were followed conservatively with complex regional pain syndrome (CRPS-1) after distal radius fracture.
- Conditions
- Distal Radius Fracture, Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome
- Being tested
- Whirlpool Bath, Contrast Bath
- Keywords
- Whirlpool, Contrast bath, hydrotherapy
- Medical subject headings
- Wrist Fractures, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whirlpool BathDevice
This group of participants will receive an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, whirlpool bath (32-38 °C) 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department.
Contrast BathDevice
This group of participants will recieve an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, contrast bath therapy which consist of 4 minutes hot water (38°C) followed by 1 minute cold water (10°C) periods for 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department.
| Study group | Role | What they receive |
|---|---|---|
| Whirlpool Bath Protocol | Experimental | An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, whirlpool bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks. Receives: Device: Whirlpool Bath |
| Contrast Bath Protocol | Experimental | An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, contrasth bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks. Receives: Device: Contrast Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion Measurement
Supination and pronation of the forearm, flexion, extension, ulnar and radial deviation active/passive range of motion of the wrist will be evaluated with a universal goniometer. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
Hand grip strength measurement with Jamar Dynamometer
Jamar Dynamometer measures isometric grip force and strength. Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow flexed at 90 degrees, wrist dorsiflexed at 0-30 degrees and ulnar deviation at 0-15 degrees with the thumb pointing up. Measurements will be repeated three times, 5 seconds apart, on the hand on the affected side, and the average of the three measurements will be recorded in kilograms. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
Secondary outcomes (5)
Jebsen Taylor Hand Function Test
This test consists of tasks involving types of grasping commonly used in daily life and evaluates the speed of individuals in these tasks.The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects. The test's scoring is recorded as the time it takes for the person to complete the tasks. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH)
Q-DASH includes 11 items extracted from the DASH questionnaire that measure physical functions and symptoms in patients with upper extremity problems. Each answer is scored from 1 to 5 on a Likert scale from good to bad; 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: no ability to do. Each section of the Quick-DASH questionnaire is scored between 0-100 (0= no disability, 100= maximum disability). Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
Patient-rated Wrist Evaluation Form
Patient-rated Wrist Evaluation Form consists of 15 questions that measure the severity of wrist pain and the level of disability in daily life activities. It has two subsections. The pain subsection consists of four questions on pain intensity and frequency, while the function subsection consists of six questions on specific activities and four questions on daily activities. Questions are rated on a 10-point scale (where 0 is no pain and 10 is worst pain). Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
Short Form 36 (SF-36)
SF-36 is a frequently used questionnaire that evaluates the functional health and well-being of patients with 36 different items. These are; physical function, physical role limitation, emotional role limitation, energy/fatigue, mental health, social function, body pain and general health perception. In the evaluation made with this scale, the last 4 weeks are taken into account and the scoring is Likert type except for some items. A total score is calculated separately for each sub-item. The scores are between "0" and "100". While the value of "100" indicates good health status, the value of "0" indicates poor health status. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: up to 12th week
Visual Analog Scale (VAS)
This method, which is aimed at determining the intensity of pain, aims to have the patient describe their pain with numbers. It is a 10 cm long line that starts with no pain (0) and ends with unbearable pain (10). Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Measured: Up to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture. Double-Blinded Prospective Randomized Trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Keskin, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769373
- Sponsor's protocol ID
- DK2025
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boersma EZ, Meent HV, Klomp FP, Frolke JM, Nijhuis-van der Sanden MWG, Edwards MJR. Treatment of Distal Radius Fracture: Does Early Activity Postinjury Lead to a Lower Incidence of Complex Regional Pain Syndrome? Hand (N Y). 2022 Jan;17(1):119-127. doi: 10.1177/1558944719895782. Epub 2020 Jan 9.
PubMed 31916452Jellad A, Salah S, Ben Salah Frih Z. Complex regional pain syndrome type I: incidence and risk factors in patients with fracture of the distal radius. Arch Phys Med Rehabil. 2014 Mar;95(3):487-92. doi: 10.1016/j.apmr.2013.09.012. Epub 2013 Sep 29.
PubMed 24080349Szekeres M, MacDermid JC, Birmingham T, Grewal R, Lalone E. The Effect of Therapeutic Whirlpool and Hot Packs on Hand Volume During Rehabilitation After Distal Radius Fracture: A Blinded Randomized Controlled Trial. Hand (N Y). 2017 May;12(3):265-271. doi: 10.1177/1558944716661992. Epub 2016 Aug 2.
PubMed 28453348
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT06769373
- Acronym / sponsor ID
- DK2025
- Conditions
- Distal Radius Fracture, Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome
- Keywords
- Whirlpool, Contrast bath, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 10 Jan 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.
The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture.
Detailed description
Distal radius fractures are the most common fracture type among all body bone fractures. Fractures generally occur in elderly patients caused by low-energy trauma due to decreased bone quality. In young patients, they mostly occur due to traumas such as traffic accidents, falls from heights and sports injuries.
One of the important complications seen after distal radius fractures is complex regional pain syndrome (CRPS). Complex regional pain syndrome represents a complication following distal radius fractures that is still not fully understood etiologically.
Studies have shown that complex regional pain syndrome is commonly diagnosed among patients recovering from a fracture of the distal radius with a reported incidence as high as 37%. It is characterized by excessive pain (allodynia and/or hyperalgesia), edema, local blood flow changes and abnormality of the sudomotor nerve.
There are hardly any studies with a sufficient evidence level to make recommendations for treatments for CRPS-1; therefore, treatment is based on symptom management. Prevention of CRPS-1, after a distal radius fracture is important as this syndrome might lead to chronic pain and serious disabilities. In several studies, it was shown that CRPS-1 can be cured with exercise and graded activities. The main goals of physiotherapy are to reduce pain, regain range of motion, and increase muscle strength and function.
Whirlpool bath and contrast bath treatments are physical therapy methods that has been used safely in complex regional pain syndrome treatment for many years.
Whirlpool baths are local baths where the extremities are immersed in rapidly circulating water. The swirling water produced by the whirlpool bath creates a massaging effect on the body, which can help relieve muscle tension and alleviate pain. The combination of warm water and hydrostatic pressure can also enhance blood circulation and improve joint mobility.
Contrast baths constitute a thermal modality whereby the hand is alternately immersed in hot and cold water for a specified temperature, time, and duration to therapeutically decrease edema, stiffness, pain and increase functionality in cases of complex regional pain syndrome after fractures.
Our primary aim is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients who were followed conservatively with complex regional pain syndrome (CRPS-1) after distal radius fracture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture. Double-Blinded Prospective Randomized Trial.
| Arm | Type | Receives |
|---|---|---|
| Whirlpool Bath Protocol | Experimental | Device: Whirlpool BathAn exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, whirlpool bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks. |
| Contrast Bath Protocol | Experimental | Device: Contrast BathAn exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, contrasth bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with complex regional pain syndrome type-1 (CRPS-type 1) after distal radius fracture, who were followed conservatively (long/short arm splint-cast) between the ages of 18-70, who applied to AFSU Physical Medicine and Rehabilitation Clinic. It is planned to use the Budapest diagnostic criteria for the diagnosis of CRPS Type 1.
Key exclusion criteria (10 listed)
- Orthopedic injuries (other accompanying orthopedic fractures, such as ulna fracture, carpal bone fractures),
- Other system injuries,
- Patients whose distal radius fractures were surgically treated,
- Patients who had previously undergone surgery on the same upper extremity,
- Nerve, tendon and artery injuries accompanying the fracture,
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 |
|---|---|---|
| Whirlpool BathThis group of participants will receive an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, whirlpool bath (32-38 °C) 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department. | Device | Whirlpool Bath Protocol |
| Contrast BathThis group of participants will recieve an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, contrast bath therapy which consist of 4 minutes hot water (38°C) followed by 1 minute cold water (10°C) periods for 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department. | Device | Contrast Bath Protocol |
Primary outcome
Range of Motion Measurement
Time frame: up to 12th week
Supination and pronation of the forearm, flexion, extension, ulnar and radial deviation active/passive range of motion of the wrist will be evaluated with a universal goniometer. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
Hand grip strength measurement with Jamar Dynamometer
Time frame: up to 12th week
Jamar Dynamometer measures isometric grip force and strength. Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow flexed at 90 degrees, wrist dorsiflexed at 0-30 degrees and ulnar deviation at 0-15 degrees with the thumb pointing up. Measurements will be repeated three times, 5 seconds apart, on the hand on the affected side, and the average of the three measurements will be recorded in kilograms. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.
5 secondary outcomes
Jebsen Taylor Hand Function Test
Time frame: up to 12th week
The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH)
Time frame: up to 12th week
Patient-rated Wrist Evaluation Form
Time frame: up to 12th week
Short Form 36 (SF-36)
Time frame: up to 12th week
Visual Analog Scale (VAS)
Time frame: Up to 12th week
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 30 Jan 2025.
- Background: PubMed 31916452Boersma EZ, Meent HV, Klomp FP, Frolke JM, Nijhuis-van der Sanden MWG, Edwards MJR. Treatment of Distal Radius Fracture: Does Early Activity Postinjury Lead to a Lower Incidence of Complex Regional Pain Syndrome? Hand (N Y). 2022 Jan;17(1):119-127. doi: 10.1177/1558944719895782. Epub 2020 Jan 9.
- Background: PubMed 24080349Jellad A, Salah S, Ben Salah Frih Z. Complex regional pain syndrome type I: incidence and risk factors in patients with fracture of the distal radius. Arch Phys Med Rehabil. 2014 Mar;95(3):487-92. doi: 10.1016/j.apmr.2013.09.012. Epub 2013 Sep 29.
- Background: PubMed 28453348Szekeres M, MacDermid JC, Birmingham T, Grewal R, Lalone E. The Effect of Therapeutic Whirlpool and Hot Packs on Hand Volume During Rehabilitation After Distal Radius Fracture: A Blinded Randomized Controlled Trial. Hand (N Y). 2017 May;12(3):265-271. doi: 10.1177/1558944716661992. Epub 2016 Aug 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whirlpool Bath and Contrast Bath in people with Distal Radius Fracture and Complex Regional Pain Syndrome Type I, run by Afyonkarahisar Health Sciences 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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Jan 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 Ersin Beştaş, MD (+905068893266, ersinbestas26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion Measurement (time frame: up to 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769373, which also lists 3 linked publications.
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 30 Jan 2025.