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The Effects of Fluidotherapy® Exercise

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ClinicalTrials.gov Identifier: NCT03649542
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Summa Health
Information provided by (Responsible Party):
Michele McCarroll, Pacific Northwest University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Wrist Fracture Other: Fluidotherapy plus exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pre/Post
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Fluidotherapy® Exercise on Wrist Fracture Rehabilitation Outcomes: A Pilot (Feasibility) Study
Actual Study Start Date : July 27, 2009
Actual Primary Completion Date : January 13, 2014
Actual Study Completion Date : January 13, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fluidotherapy® plus exercises group (FLO)
The Fluidotherapy® Unit and exercises group (FLO). They were required to complete wrist exercises in Fluidotherapy® Unit box for 15 minutes with the following exercises finger abduction/adduction, finger flexion/extension, forearm supination/pronation, wrist flexion/extension, and wrist radial deviation/ulnar deviation. Each patient performed two sets of fifteen repetitions for each exercise, totaling 15-minutes.
Other: Fluidotherapy plus exercise
The Fluidotherapy® unit (ULTRA 115: Henley International, Sugar Land, Texas) is a high intensity heat modality consisting of a dry whirlpool of finely divided solid particles suspended in a heated air stream. A certified technician The cleaned the Fluidotherapy® unit per the user manual.
Other Name: Exercise Only

No Intervention: Exercises only group (EX)
They were required to complete wrist exercises in the air for 15 minutes, including abduction/adduction, finger flexion/extension, forearm supination/pronation, wrist flexion/extension, and wrist radial deviation/ulnar deviation. Each patient performed two sets of fifteen repetitions for each exercise, totaling 15-minutes.



Primary Outcome Measures :
  1. active range of motion (AROM) [ Time Frame: 15 minutes after ]
    Using a goniometer, Scale and measured the patient's supination, pronation, wrist flexion and extension, wrist radial deviation, and wrist ulnar deviation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Michele McCarroll, Co-Investigator, Pacific Northwest University of Health Sciences
ClinicalTrials.gov Identifier: NCT03649542    
Other Study ID Numbers: SUMMA IRB - FLUIDOTHERAPY
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries