The Effects of Fluidotherapy® Exercise

NCT03649542 | Completed

• 1 other identifier: SUMMA IRB - FLUIDOTHERAPY
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Fracture

Outcome Measures

Primary Outcomes (1)

• active range of motion (AROM)

  Using a goniometer, Scale and measured the patient's supination, pronation, wrist flexion and extension, wrist radial deviation, and wrist ulnar deviation.

  15 minutes after

Study Arms (2)

Fluidotherapy® plus exercises group (FLO)

ACTIVE COMPARATOR

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

Exercises only group (EX)

NO INTERVENTION

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.

Interventions

Fluidotherapy plus exercise OTHER

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.

Also known as: Exercise Only

Fluidotherapy® plus exercises group (FLO)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Northwest University of Health Sciences: lead
• Summa Health System: collaborator

MeSH Terms

Conditions

Wrist Fractures

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/Post

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: July 27, 2009
• Primary Completion: January 13, 2014
• Study Completion: January 13, 2014
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share