First-degree Ankle Sprains

October 14, 2024 updated by: Darko Bilic, Rehabilitation Centre Zivot
Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The sample is a convenience sample and will include individuals diagnosed with Grade I acute ankle sprain who present for examination at the specified institutions. After a proper diagnosis, confirmation of inclusion in the study, and signed ethical consent for participation in the research, randomization of participants will be conducted using an electronic number generator on the website www.randomizer.org/form:htm.

Description

Inclusion Criteria:

  • Individuals diagnosed with Grade I acute ankle sprain confirmed by a specialist physician in radiology,
  • Age of participants ≥ 18 years,
  • Individuals of both sexes

Exclusion Criteria:

  • Recurrent ankle injury,
  • Acute ankle sprains of Grade II and III,
  • Presence of other physical and/or mental health issues.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental Group
In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.
Other: Cryotherapy
cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.
Other Names:
  • cryotheraphy
  • braces
  • Bowen technique
Control Group
In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and manual massage.
Other: Cryotherapy
cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.
Other Names:
  • cryotheraphy
  • braces
  • Bowen technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of pain intensity
Time Frame: 3 weeks
Measured on a numerical scale ranging from 0 to 10
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehabilitation Centre Zivot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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