Fluidotherapy in Patients With Distal Radius Fractures

NCT06272877 | Completed

• 1 other identifier: 129944-54
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distal Radius Fractures; Edema Arm; Pain

Keywords

Distal Radius Fractures; edema; pain; physical therapy; fluidotherapy

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6th week

Secondary Outcomes (6)

• Gross Grip Strength:

  Baseline

• Gross Grip Strength:

  2th week

• Gross Grip Strength:

  6th week

• Patient-Rated Wrist Evaluation (PRWE) questionnaire

  Baseline

• Patient-Rated Wrist Evaluation (PRWE) questionnaire

  2th week

Study Arms (2)

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.

Other: Fluidotherapy; Other: conventional rehabilitation program

Control group

ACTIVE COMPARATOR

Only the conventional rehabilitation program will be applied by a physiotherapist for 6 weeks.

Other: conventional rehabilitation program

Interventions

Fluidotherapy OTHER

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.

Fluidotherapy Group

conventional rehabilitation program OTHER

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

Control group; Fluidotherapy Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treating with a cast due to distal radius fracture being over 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Research and Training Hospital

Kırşehir, Kişrsehşr, 40100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28893496 BACKGROUND

• 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.

  PMID: 34668847 BACKGROUND

• 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.

  PMID: 7443789 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures; Pain; Edema

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Levent Horoz, Asst Prof

  Kirsehir Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and the outcomes assesor will be different persons. Statician will be different person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 22, 2024
• Study Start: March 20, 2024
• Primary Completion: January 24, 2025
• Study Completion: February 24, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)