Clinical trial NCT03649542: The Effects of Fluidotherapy® Exercise
Official title: The Effects of Fluidotherapy® Exercise on Wrist Fracture Rehabilitation Outcomes: A Pilot (Feasibility) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Fracture
Lead sponsor: Pacific Northwest University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Summa Health System
First posted: 2018-08-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre/Post
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Participants must be referred to outpatient rehabilitation at St. Thomas Hospital, Akron, Ohio.
* Patients diagnosed with a wrist fracture will include those patients with distal radius fractures, distal radius/ulna fractures, and distal ulna fractures. Patients who have had closed reductions, open reductions, internal fixation, and/or external fixation will all be included.
* Patients will be recruited for this study if they have been cleared by the referring physician on the order to safely begin wristrange of motion.

Exclusion Criteria:

* Have open wounds
* Have Hepatitis
* Currently have chicken pox or shingles
* Have other serious fractures in the arm
* Have blood circulation problems in the arms or legs
* Do not have a physician referral to outpatient rehab
* Fractured wrist less than 6-weeks old as of evaluation day
* Fractured wrist over a year ago
* Under the age of 18 and over the age of 85 years at the time of participation

Primary outcomes:
measure: active range of motion (AROM)
timeFrame: 15 minutes after
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: