Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03649542 |
| Other study ID # |
SUMMA IRB - FLUIDOTHERAPY |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 27, 2009 |
| Est. completion date |
January 13, 2014 |
Study information
| Verified date |
April 2024 |
| Source |
Pacific Northwest University of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
BACKGROUND: Wrist fractures are a common upper extremity injury treated by hand therapists.
Currently, there is a dearth of published literature supporting the use Fluidotherapy® to
improve pain and range of motion (ROM) in wrist fracture patients. \OBJECTIVE: This pilot
study was conducted to determine the effects of one 15-minute bout of performing active range
of motion (AROM) exercises in Fluidotherapy® (EXFT) versus AROM exercises (EX) alone on pain
levels and AROM in wrist fracture subjects. METHODS: Eight subjects diagnosed with a wrist
fracture (distal radius fracture, distal radius/ulna fractures, or distal ulna fracture) and
referred to outpatient rehabilitation/occupational therapy were recruited upon his/her
initial therapy evaluation. RESULTS: There were no significant differences between EX and
EXFT groups in all outcome variables except for self-reported numeric pain scores (p=0.03*)
and a trend towards significance in pronation AROM (p=0.06**). Even with a small sample size
(n=8) there were significant differences in self-reported pain between the two groups.
CONCLUSION: This study confirms that even after one 15-minute bout of AROM exercises in
Fluidotherapy® treatment, patients report improved pain tolerance and may be useful in pain
management techniques after a wrist fracture.
Description:
BACKGROUND: Wrist fractures are a common upper extremity injury treated by hand therapists.
Fluidotherapy® is a high intensity heat modality consisting of a dry whirlpool of finely
divided solid particles suspended in a heated air stream, the mixture having the properties
of a liquid. Currently, there is a dearth of published literature supporting the use
Fluidotherapy® to improve pain and range of motion (ROM) in wrist fracture patients. More
importantly, there is no evidence for the reduction of perceived wrist pain or improved ROM
after only one 15-minute bout of Fluidotherapy®. OBJECTIVE: This pilot study was conducted to
determine the effects of one 15-minute bout of performing active range of motion (AROM)
exercises in Fluidotherapy® (EXFT) versus AROM exercises (EX) alone on pain levels and AROM
in wrist fracture subjects. METHODS: Eight subjects diagnosed with a wrist fracture (distal
radius fracture, distal radius/ulna fractures, or distal ulna fracture) and referred to
outpatient rehabilitation/occupational therapy were recruited upon his/her initial therapy
evaluation. Patients with closed reductions, open reductions, internal fixation, and/or
external fixation were included as well. Subjects were randomly assigned to either the EXFT
group or the EX group. A numeric pain scale (0-10) was used to assess perceived pain and AROM
measurements using a goniometer were taken for pronation, supination, flexion, extension,
radial deviation, and ulnar deviation immediately prior to intervention and after
intervention. RESULTS: EX Group Pre-Treatment results: Pain 4.0 (± 1.82); Supination AROM
75.5 (± 10.90); Pronation AROM 75 (± 7.02); Flexion AROM 34.5 (± 9.88); Extension AROM 43.5
(± 8.96); Radial Deviation AROM 18.75 (± 9.43); Ulnar Deviation AROM 23.5 (± 4.36); Exercise
in Fluidotherapy® Group Pre-Treatment results: Pain 2.5 (± 2.08); Supination AROM 65 (±
18.70); Pronation AROM 81.25 (± 6.29); Flexion AROM 40.25 (± 17.23); Extension AROM 38.5 (±
12.07); Radial Deviation AROM 21.25 (± 10.31); Ulnar Deviation AROM 26.25 (± 12.5); EX Group
Post-Treatment results: Pain 4.5 (± 2.52); Supination AROM 81.75 (± 9.18); Pronation AROM 79
(± 3.46); Flexion AROM 36.25 (± 9.84); Extension AROM 50.5 (± 15.42); Radial Deviation AROM
21.5 (± 9.94); Ulnar Deviation AROM 23.75 (± 5.19); Exercise in Fluidotherapy® Group
Pre-Treatment results: Pain 0.75 (± 0.98); Supination AROM 72.5 (± 14.43); Pronation AROM
86.25 (± 4.79); Flexion AROM 47.5 (± 15.54); Extension AROM 51.25 (± 8.54); Radial Deviation
AROM 25.5 (± 12.80); Ulnar Deviation AROM 29 (± 8.41); There were no significant differences
between EX and EXFT groups in all outcome variables except for self-reported numeric pain
scores (p=0.03*) and a trend towards significance in pronation AROM (p=0.06**). Even with a
small sample size (n=8) there were significant differences in self-reported pain between the
two groups. CONCLUSION: The application of heat, massage, sensory stimulation, levitation,
and pressure oscillations seem to provide patients pain relief and improvements in range of
motion after AROM exercises in Fluidotherapy®. This study confirms that even after one
15-minute bout of AROM exercises in Fluidotherapy® treatment, patients report improved pain
tolerance and may be useful in pain management techniques after a wrist fracture.
