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Trial record 47 of 346 for:    sprains and strains

Neurocryostimulation for Acute Lateral Ankle Sprain

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ClinicalTrials.gov Identifier: NCT02945618
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jean-Sébastien Roy, Laval University

Brief Summary:
The objective of this exploratory randomized control trial is to compare, in participants with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations between two groups of subjects who undergo a conventional rehabilitation program with (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS will lead to a faster reduction of symptoms and functional limitations, and a faster return to daily living activities.Thirty-six participants of 18 years of age and older with acute LAS (sustained a LAS three days or less before the first evaluation session) will be recruited and randomly assigned to either a group receiving conventional rehabilitation program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving the conventional rehabilitation program (comparison group; n=18). This single-blind (evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline, day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3 sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome will be the functional limitations, evaluated using the Lower Extremity Functional Scale (LEFS).

Condition or disease Intervention/treatment Phase
Ankle Sprain Device: Neurocryostimulation Other: Ice Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocryostimulation for the Treatment of Acute Lateral Ankle Sprain : a Single Blind Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Neurocryostimulation

CRYOFOS will be applied on the ankle at the end of each of the 8 sessions (in accordance to the protocol established). The treatment time with the CRYOFOS will take between 1 and 2 minutes, and will be pain-free.

Both groups will also receive the same conventional program consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing.

Device: Neurocryostimulation

CRYOFOS will be applied on the ankle at the end of each of the 8 sessions (in accordance to the protocol established). The treatment time with the CRYOFOS will take between 1 and 2 minutes, and will be pain-free.

Both groups will also receive the same conventional program consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing.

Other Names:
  • Hyperbaric gazeous cryotherapy
  • Cryostimulation

Active Comparator: Conventional program with ice
The control group will receive the same conventional program (as the experimental group) consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing. Ice will be applied to the ankle for 15 minutes at the end of each of the 8 sessions.
Other: Ice
The control group will receive the same conventional program (as the experimental group) consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing. Ice will be applied to the ankle for 15 minutes at the end of each of the 8 sessions.
Other Name: Conventional program with ice




Primary Outcome Measures :
  1. Change from Baseline in lower limb functional level at 6 weeks [ Time Frame: Baseline-6 weeks ]
    Lower Extremity Functional Scale (LEFS), an auto-administered questionnaire of functional capacity


Secondary Outcome Measures :
  1. Change from Baseline in pain level at 6 weeks [ Time Frame: Baseline-6 weeks ]
    Visual analog scale for pain

  2. Change from Baseline in pain level at 1 week [ Time Frame: Baseline-1 week ]
    Visual analog scale for pain

  3. Change from Baseline in pain level at 2 weeks [ Time Frame: Baseline-2 weeks ]
    Visual analog scale for pain

  4. Change from Baseline in pain level at 4 weeks [ Time Frame: Baseline-4 weeks ]
    Visual analog scale for pain

  5. Change from Baseline in ankle oedema at 6 weeks [ Time Frame: Baseline-6 weeks ]
    Figure-of-eight for ankle oedema

  6. Change from Baseline in ankle oedema at 4 weeks [ Time Frame: Baseline-4 weeks ]
    Figure-of-eight for ankle oedema

  7. Change from Baseline in ankle oedema at 2 weeks [ Time Frame: Baseline-2 weeks ]
    Figure-of-eight for ankle oedema

  8. Change from Baseline in ankle oedema at 1 week [ Time Frame: Baseline-1 week ]
    Figure-of-eight for ankle oedema

  9. Change from Baseline in dorsiflexion range of motion at 6 weeks [ Time Frame: Baseline-6 weeks ]
    Hallux-to-wall distance for dorsiflexion range of motion

  10. Change from Baseline in dorsiflexion range of motion at 1 week [ Time Frame: Baseline-1 week ]
    Hallux-to-wall distance for dorsiflexion range of motion

  11. Change from Baseline in dorsiflexion range of motion at 2 weeks [ Time Frame: Baseline-2 weeks ]
    Hallux-to-wall distance for dorsiflexion range of motion

  12. Change from Baseline in dorsiflexion range of motion at 4 weeks [ Time Frame: Baseline-4 weeks ]
    Hallux-to-wall distance for dorsiflexion range of motion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LAS three days or less before the first evaluation session
  • presence of a lateral hematoma and swelling
  • tenderness at the anterior lateral ligament without or with anterior drawer instability

Exclusion Criteria:

  • present a bony ankle injury (indicated by Ottawa ankle rules)
  • had sustained a similar injury of the same joint within the last 6 months
  • require bed rest, hospitalisation, casting or surgery
  • had a previous fracture of the same ankle
  • signs or symptoms of a previous injury at any of the other joints of the lower limbs or trunk
  • contraindication to cryotherapy including cryoglobulinemia, peripheral vascular disease or Raynaud's syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945618


Contacts
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Contact: Jean-Sebastien Roy, PT, PhD 1-418-529-9141 ext 6005 jean-sebastien.roy@rea.ulaval.ca

Locations
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Canada
Laval University Recruiting
Québec, Canada, G1V 0A6
Contact: Jean Tittley, MSc cand.    418 656-5501    jean_tittley@yahoo.com   
Sub-Investigator: Jean Tittley, MSc cand.         
Principal Investigator: Jean-Sébastien Roy, PhD         
Sub-Investigator: Luc J Hébert, PhD         
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Jean-Sebastien Roy, PhD Universite Laval

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Responsible Party: Jean-Sébastien Roy, Associate Professor, Laval University
ClinicalTrials.gov Identifier: NCT02945618     History of Changes
Other Study ID Numbers: Cryofos
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean-Sébastien Roy, Laval University:
cryotherapy
physical therapy

Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries