- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06272877
Fluidotherapy in Patients With Distal Radius Fractures
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kişrsehşr
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Kirsehir, Kişrsehşr, Turkey, 40100
- Kirsehir Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Treating with a cast due to distal radius fracture being over 18 years old
Exclusion Criteria:
- 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
- Heart and circulatory system disorders
- Hepatitis, Measles, Sepsis infectious diseases or fever
- Open wound on the applied hand.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Only the conventional rehabilitation program will be applied by a physiotherapist for 6 weeks.
|
The conventional rehabilitation program determined before the study will be implemented by a physiotherapist in the hospital for 6 weeks.
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|
Experimental: Fluidotherapy Group
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.
|
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.
The conventional rehabilitation program determined before the study will be implemented by a physiotherapist in the hospital for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6th week
|
|
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.
|
Baseline
|
|
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.
|
2th week
|
|
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.
|
Baseline
|
|
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.
|
2th week
|
|
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.
|
6th week
|
|
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.
|
Baseline
|
|
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.
|
2th week
|
|
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.
|
6th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Grip Strength:
Time Frame: Baseline
|
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
|
Baseline
|
|
Gross Grip Strength:
Time Frame: 2th week
|
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
|
2th week
|
|
Gross Grip Strength:
Time Frame: 6th week
|
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
|
6th week
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: Baseline
|
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. |
Baseline
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: 2th week
|
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. |
2th week
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: 6th week
|
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. |
6th week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Levent Horoz, Asst Prof, Kirsehir Research and Training Hospital
Publications and helpful links
General Publications
- Borrell 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.
- 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.
- Gutierrez-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129944-54
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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