NCT06645262

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 14, 2024

Last Update Submit

October 14, 2024

Conditions

Keywords

ankle sprainBowen technique

Outcome Measures

Primary Outcomes (1)

  • Subjective assessment of pain intensity

    Measured on a numerical scale ranging from 0 to 10

    3 weeks

Study Arms (2)

Experimental Group

In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.

Other: Cryotherapy

Control Group

In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and manual massage.

Other: Cryotherapy

Interventions

cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.

Also known as: cryotheraphy, braces, Bowen technique
Control GroupExperimental Group

Eligibility Criteria

Age18 Weeks+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Centre Život

Mostar, 88000, Bosnia and Herzegovina

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Interventions

CryotherapyBraces

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsOrthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Central Study Contacts

Darko Bilić, mag.fizio.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 16, 2024

Study Start

June 12, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations