Fluidotherapy in Patients With Distal Radius Fractures

Pain Clinical Trial

Official title:

Effectiveness of Fluidotherapy in Patients With Conservatively Treated Distal Radius Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272877
• Other study ID #: 129944-54
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: July 20, 2024

Study information

• Verified date: February 2024
• Source: Ahi Evran University Education and Research Hospital
• Contact: Levent Horoz, Asst Prof
• Phone: +90 386 280 39 00
• Email: dr.leventhoroz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fractures
• Edema Arm
• Fractures, Bone
• Pain
• Radius Fractures
• Wrist Fractures

Intervention

Other:
• Fluidotherapy
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 program
The conventional rehabilitation program determined before the study will be implemented by a physiotherapist in the hospital for 6 weeks.

Locations

Country	Name	City	State
Turkey	Kirsehir Research and Training Hospital	Kirsehir	Kisrsehsr

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evran University Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.	Baseline
Primary	Visual analog scale	Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.	2th week
Primary	Visual analog scale	Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale.	6th week
Primary	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.	Baseline
Primary	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.	2th week
Primary	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.	6th week
Primary	Circumference (mm)	nvironmental Measurement; 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
Primary	Circumference (mm)	nvironmental Measurement; 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
Primary	Circumference (mm)	nvironmental Measurement; 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	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	Baseline
Secondary	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	2th week
Secondary	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	6th week
Secondary	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.	Baseline
Secondary	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.	2th week
Secondary	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.	6th week