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Completed

NCT Number: NCT04071002

Patients With Distal Radius Fracture

Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Kinikli, 20000, Turkey (Türkiye)

About this study

Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.

The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p<0,05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18 and 60
  • Diagnosed with distal radius fracture
  • Primary fixation after injury.

Exclusion criteria

  • Bilateral distal radius fracture
  • Concomitant ulna styloid fracture
  • Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
  • Patients who underwent surgery that involved ipsilateral upper extremity
  • Associated injuries such as nerve or tendon injuries
  • Secondary procedures at follow-up
  • Un-cooperated patients.

Treatment and study plan

12 weeks physical therapy programme

Other

The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: six month

    To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.

  2. algometer

    Time frame: six month

    An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .

  3. range of motion

    Time frame: six month

    An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.

  4. grip strength

    Time frame: six month

    Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.

  5. radiographic evaluations

    Time frame: six month

    The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.

  6. Push-Off Test (POT)

    Time frame: six month

    POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.

  7. Michigan Hand Outcomes Questionnaire (MHOQ)

    Time frame: six month

    MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.

  8. Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)

    Time frame: six month

    It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.

  9. Jebsen-Taylor Hand Function Test (JTHFT)

    Time frame: six month

    The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

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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