Compression Gloves for Distal Radius Fracture

Distal Radius Fractures Clinical Trial

Official title:

The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518179
• Other study ID #: K-11-0131-CTIL
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Distal Radius Fractures
• Fracture of Lower End of Radius
• Fractures, Bone
• Radius Fractures
• Smith's Fracture

Intervention

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

Other:
• Routine follow up and treatment
Control

Locations

Country	Name	City	State
Israel	Clalit Health Services	Haifa
Israel	Clalit Health Services, Haifa and Western Galilee District	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Miller-Shahabar I, Schreuer N, Katsevman H, Bernfeld B, Cons A, Raisman Y, Milman U. Efficacy of Compression Gloves in the Rehabilitation of Distal Radius Fractures: Randomized Controlled Study. Am J Phys Med Rehabil. 2018 Dec;97(12):904-910. doi: 10.1097 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).	Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).	1 year
Secondary	Swelling of the hand and fingers (using CM ribbon)	Swelling of the hand and fingers (using CM ribbon)	10 week
Secondary	Range of motion of the fingers and wrist (using Goniomater)	Range of motion of the fingers and wrist (using Goniomater)	10 weeks
Secondary	Strength of the hand (using the Gamar Dynamometer in KG).	Strength of the hand (using the Gamar Dynamometer in KG).	10 weeks
Secondary	Pain (using VAS as part of PRWE)	Pain (using VAS as part of PRWE)	10 weeks
Secondary	Overall satisfaction of using the compression gloves (using self reported questionnaire).	Overall satisfaction of using the compression gloves (using self reported questionnaire).	10 weeks