Compression Gloves for Distal Radius Fracture

Not Applicable

Completed

• Conditions: Distal Radius Fractures; Colles' Fracture; Fracture of Lower End of Radius; Smith's Fracture
• Interventions: Device: Made-to-Measure Compression Gloves; Other: Routine follow up and treatment

• Registration Number: NCT01518179
• Lead Sponsor: Clalit Health Services

Brief Summary

Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.

Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).

This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.

Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.

ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):

S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).

S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)

Detailed Description

Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.

Study Timeline

• Study First Submitted: 2012-01-21
• Study First Submitted QC: 2012-01-21
• Study First Posted: 2012-01-25
• Study Start: 2012-04
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.

2. Patients who demonstrate at enrolment at least two of the following:

   • Pain,
   • limited range of motion of the fingers and the wrist,
   • limited strength (weakness of the hand/fingers),
   • swelling /edema,
   • Limited hand functions during performance of Activities of Daily Living (ADL).

Exclusion Criteria

• Neuropathy
• Peripheral vascular disease
• End stage renal disease
• Previous impairment of fingers/wrist range of motion.
• Previous Lymphedema of the injured hand
• Receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids).
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Made-to-Measure Compression Gloves	Made-to-Measure Compression Gloves	Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Control	Routine follow up and treatment	Routine follow up and treatment

Primary Outcome Measures

Name	Time	Method
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).	1 year	Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).

Secondary Outcome Measures

Name	Time	Method
Swelling of the hand and fingers (using CM ribbon)	10 week	Swelling of the hand and fingers (using CM ribbon)
Range of motion of the fingers and wrist (using Goniomater)	10 weeks	Range of motion of the fingers and wrist (using Goniomater)
Strength of the hand (using the Gamar Dynamometer in KG).	10 weeks	Strength of the hand (using the Gamar Dynamometer in KG).
Pain (using VAS as part of PRWE)	10 weeks	Pain (using VAS as part of PRWE)
Overall satisfaction of using the compression gloves (using self reported questionnaire).	10 weeks	Overall satisfaction of using the compression gloves (using self reported questionnaire).

Trial Locations

Locations (2)

Clalit Health Services, Haifa and Western Galilee District; 🇮🇱 Haifa, Israel

Clalit Health Services; 🇮🇱 Haifa, Israel