Compression Gloves for Distal Radius Fracture

Clalit Health Services

Status: Completed

Conditions: Distal Radius Fractures; Smith's Fracture; Colles' Fracture; Fracture of Lower End of Radius

Treatments: Device: Made-to-Measure Compression Gloves; Other: Routine follow up and treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01518179

K-11-0131-CTIL

Details and patient eligibility

About

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)

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

Made-to-Measure Compression Gloves

Experimental group

Description:

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

Treatment:

Device: Made-to-Measure Compression Gloves

Control

Other group

Description:

Routine follow up and treatment

Treatment:

Other: Routine follow up and treatment