ClinicalTrials.gg
RecruitingNCT06769373Updated Jan 30, 2025

The Effects of Whirlpool and Contrast Bath in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture

An interventional study of Whirlpool Bath and Contrast Bath in Distal Radius Fracture, Complex Regional Pain Syndrome Type I and Complex Regional Pain Syndrome, sponsored by Afyonkarahisar Health Sciences University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 27 studies in Wrist Fractures with a site in Turkey — 6 open to participants now, 6 under way, none of them phase 3. Wrist Fractures · Turkey.

Planned enrollment
12th of 19
40 · median 44
Started
2025
with 1 other
No phase
18 of 27
3 open now
Registered
18th of 27
by date
Lead sponsor
1 of 27
Afyonkarahisar Health Sciences University

Among the 27 studies in Wrist Fractures with a site in Turkey, this one is the 12th largest by planned enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2025, is one of 18 with no phase, and was the 18th registered.

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.

Browse Wrist Fractures studies →

Open to participants now

6 of the 27 studies in Wrist Fractures with a site in Turkey are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 43 Wrist Fractures studies recruiting now, 20 (47%) set no upper age limit and 15 (35%) stop at 75 or younger; 7 take children under 18; 6 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Distal Radius Fracture
  • Complex Regional Pain Syndrome Type I
  • Complex Regional Pain Syndrome

Keywords

  • Whirlpool
  • Contrast bath
  • hydrotherapy
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Whirlpool Bath Protocol

    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.

    Device: Whirlpool Bath

  • Experimental
    Contrast Bath Protocol

    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.

    Device: Contrast Bath

Interventions

  • DeviceWhirlpool Bath

    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.

  • DeviceContrast Bath

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 12th week

  2. 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.

    Time frame: up to 12th week

Secondary outcomes

  1. 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.

    Time frame: up to 12th week

  2. 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.

    Time frame: up to 12th week

  3. 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.

    Time frame: up to 12th week

  4. 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.

    Time frame: up to 12th week

  5. 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.

    Time frame: Up to 12th week

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 31916452 ↗
  • Jellad 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 24080349 ↗
  • Szekeres 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Mar 2025, 1 month later.

Of 126 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 1 month is below that.

Counting every sponsor, half of 127 studies reached it within 25 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2025
First posted
Jan 10, 2025
StartEst.
Jan 31, 2025
Primary completionEst.
Mar 15, 2025
CompletionEst.
Jun 15, 2025
Last update
Jan 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06769373
Responsible party
Duygu Keskin (Research Assistant Doctor, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Jan 10, 2025
Start date
Jan 31, 2025 (estimated)
Primary completion
Mar 15, 2025 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Jan 30, 2025

Study contacts

Ersin Beştaş, MD
Contact
ersinbestas26@gmail.com
+905068893266
Duygu Keskin, research assistant
Contact
keskiin01@hotmail.com
+905077902716

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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