Clinical trial NCT01518179: Compression Gloves for Distal Radius Fracture
Official title: The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Fracture of Lower End of Radius
Colles' Fracture
Smith's Fracture
Keywords: Colles' Fracture
Compression Bandages
Occupational therapy
Rehabilitation
Smith's fracture
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2012-01-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
timeFrame: 1 year
Secondary outcomes:
measure: Swelling of the hand and fingers (using CM ribbon)
timeFrame: 10 week
measure: Range of motion of the fingers and wrist (using Goniomater)
timeFrame: 10 weeks
measure: Strength of the hand (using the Gamar Dynamometer in KG).
timeFrame: 10 weeks
measure: Pain (using VAS as part of PRWE)
timeFrame: 10 weeks
measure: Overall satisfaction of using the compression gloves (using self reported questionnaire).
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services, Haifa and Western Galilee District
city: Haifa
country: Israel
facility: Clalit Health Services
Study officials:
affiliation: Clalit Health Services
name: Benny Brnfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Uzi Milman, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL
name: Naomi Schreuer, Ph.D., OTR
role: STUDY_CHAIR
affiliation: Clalit Health Services
name: Inbar Miler, OCT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/PHM.0000000000000998.