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NCT Number: NCT06272877

Fluidotherapy in Patients With 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.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Edema Edema Arm Fractures, Bone Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirsehir Research and Training Hospital

Kırşehir, Kişrsehşr, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

conventional rehabilitation program

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Gross Grip Strength:

    Time frame: Baseline

    Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength

  2. Gross Grip Strength:

    Time frame: 2th week

    Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength

  3. Gross Grip Strength:

    Time frame: 6th week

    Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Official study title

Effectiveness of Fluidotherapy in Patients With Conservatively Treated Distal Radius Fractures

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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