Distal Radius FracturesNCT06272877
Fluidotherapy in Patients With Distal Radius Fractures
A study testing Fluidotherapy and conventional rehabilitation program in people with Distal Radius Fractures and Edema Arm, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Distal Radius Fractures, Edema Arm, Pain
- What is being tested?
- Fluidotherapy and conventional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Treating with a cast due to distal radius fracture being over 18 years old
Who cannot join
- Presence of polytrauma
- History of previous limb-related surgery
- Hemiplegia in the involved limb
- Contracture in the involved limb
- Arterial and venous occlusions
- Lymphatic system disorders
Show all 9Show fewer
- Heart and circulatory system disorders
- Hepatitis, Measles, Sepsis infectious diseases or fever
- Open wound on the applied hand.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Research and Training Hospital
Kırşehir, Kişrsehşr, 40100
About this study
Official title: Effectiveness of Fluidotherapy in Patients With Conservatively Treated Distal Radius Fractures
Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.
Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase.
Read the detailed description
Reducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various massage and mobilization methods were applied to this patient population in the postoperative period. In a recent study evaluating the effectiveness of Whirlpool treatment, it was reported that studies on the effectiveness of fluidotherapy are also needed. There is no study in the literature evaluating the effectiveness of fluidotherapy in the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.
This study aimed to evaluate the effect of adding fluidotherapy to the early rehabilitation program on pain, edema, joint range of motion and functionality after the cast is removed in patients who received conservative cast treatment due to distal radius fracture.
- Conditions
- Distal Radius Fractures, Edema Arm, Pain
- Being tested
- Fluidotherapy, conventional rehabilitation program
- Keywords
- Distal Radius Fractures, edema, pain, physical therapy, fluidotherapy
- Medical subject headings
- Wrist Fractures, Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidotherapyOther
Fluidotherapy is a dry environment created by mobilizing solid particles using heated air flow. Fluidotherapy will be applied 20 minutes a day, 5 days a week for 4 weeks.
conventional rehabilitation programOther
The conventional rehabilitation program determined before the study will be implemented by a physiotherapist in the hospital for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fluidotherapy Group | Experimental | Fluidotherapy will be applied to the group in addition to the conservative rehabilitation program received by the control group. Fluidotherapy will be applied 20 minutes a day, 5 days a week for 4 weeks. Receives: Other: Fluidotherapy; Other: conventional rehabilitation program |
| Control group | Active comparator | Only the conventional rehabilitation program will be applied by a physiotherapist for 6 weeks. Receives: Other: conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Measured: Baseline
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Measured: 2th week
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Measured: 6th week
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: Baseline
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: 2th week
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: 6th week
Circumference (mm)
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: Baseline
Circumference (mm)
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: 2th week
Circumference (mm)
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: 6th week
Secondary outcomes (6)
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: Baseline
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: 2th week
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: 6th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: Baseline
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: 2th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start20 Mar 2024
- Primary completion24 Jan 2025
- Study completion24 Feb 2025
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 FracturesStudies 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
- Randomised controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Horoz, Ahi Evran University Education and Research Hospital
- Investigators
- Levent Horoz, Asst Prof, Principal investigator, Kirsehir Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272877
- Sponsor's protocol ID
- 129944-54
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szekeres M, MacDermid JC, Grewal R, Birmingham T. The short-term effects of hot packs vs therapeutic whirlpool on active wrist range of motion for patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jul-Sep;31(3):276-281. doi: 10.1016/j.jht.2017.08.003. Epub 2017 Oct 12.
PubMed 28893496Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20.
PubMed 34668847Borrell RM, Parker R, Henley EJ, Masley D, Repinecz M. Comparison of in vivo temperatures produced by hydrotherapy, paraffin wax treatment, and Fluidotherapy. Phys Ther. 1980 Oct;60(10):1273-6. doi: 10.1093/ptj/60.10.1273.
PubMed 7443789
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Fluidotherapy in Patients With Conservatively Treated Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT06272877
- Acronym / sponsor ID
- 129944-54
- Conditions
- Distal Radius Fractures, Edema Arm, Pain
- Keywords
- Distal Radius Fractures, edema, pain, physical therapy, fluidotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 22 Feb 2024 (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.
Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.
Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase.
Detailed description
Reducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various massage and mobilization methods were applied to this patient population in the postoperative period. In a recent study evaluating the effectiveness of Whirlpool treatment, it was reported that studies on the effectiveness of fluidotherapy are also needed. There is no study in the literature evaluating the effectiveness of fluidotherapy in the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.
This study aimed to evaluate the effect of adding fluidotherapy to the early rehabilitation program on pain, edema, joint range of motion and functionality after the cast is removed in patients who received conservative cast treatment due to distal radius fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| Fluidotherapy Group | Experimental | Other: Fluidotherapy, Other: conventional rehabilitation programFluidotherapy will be applied to the group in addition to the conservative rehabilitation program received by the control group. Fluidotherapy will be applied 20 minutes a day, 5 days a week for 4 weeks. |
| Control group | Active comparator | Other: conventional rehabilitation programOnly the conventional rehabilitation program will be applied by a physiotherapist for 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Treating with a cast due to distal radius fracture being over 18 years old
Key exclusion criteria (9 listed)
- Presence of polytrauma
- History of previous limb-related surgery
- Hemiplegia in the involved limb
- Contracture in the involved limb
- Arterial and venous occlusions
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 |
|---|---|---|
| FluidotherapyFluidotherapy is a dry environment created by mobilizing solid particles using heated air flow. Fluidotherapy will be applied 20 minutes a day, 5 days a week for 4 weeks. | Other | Fluidotherapy Group |
| conventional rehabilitation programThe conventional rehabilitation program determined before the study will be implemented by a physiotherapist in the hospital for 6 weeks. | Other | Control group, Fluidotherapy Group |
Primary outcome
Visual analog scale
Time frame: Baseline
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Visual analog scale
Time frame: 2th week
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Visual analog scale
Time frame: 6th week
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.A score of 0 indicates the best result, a score of 10 indicates the worst result. Higher scores indicate higher pain.
Wrist joint range of motion
Time frame: Baseline
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Wrist joint range of motion
Time frame: 2th week
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Wrist joint range of motion
Time frame: 6th week
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Circumference (mm)
Time frame: Baseline
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Circumference (mm)
Time frame: 2th week
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Circumference (mm)
Time frame: 6th week
Environmental Measurement; the both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
6 secondary outcomes
Gross Grip Strength:
Time frame: Baseline
Gross Grip Strength:
Time frame: 2th week
Gross Grip Strength:
Time frame: 6th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: Baseline
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: 2th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 28893496Szekeres M, MacDermid JC, Grewal R, Birmingham T. The short-term effects of hot packs vs therapeutic whirlpool on active wrist range of motion for patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jul-Sep;31(3):276-281. doi: 10.1016/j.jht.2017.08.003. Epub 2017 Oct 12.
- Background: PubMed 34668847Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20.
- Background: PubMed 7443789Borrell RM, Parker R, Henley EJ, Masley D, Repinecz M. Comparison of in vivo temperatures produced by hydrotherapy, paraffin wax treatment, and Fluidotherapy. Phys Ther. 1980 Oct;60(10):1273-6. doi: 10.1093/ptj/60.10.1273.
- 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. This study is not recruiting at the moment.
Levent Horoz, Asst Prof principal investigator
Kirsehir Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluidotherapy and conventional rehabilitation program in people with Distal Radius Fractures and Edema Arm, run by Ahi Evran University Education and Research Hospital 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 9 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: finished, as of the sponsor's last update on 11 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: Baseline). The study lists 9 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 NCT06272877, 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 11 Apr 2025.