- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287020
PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation
PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation: a Prospective Comparative Study of Muscle Strength and Dynamic Balance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized study evaluated two early management approaches for adolescents with first-time lateral ankle sprain. Participants aged 12 to 17 years who presented within 1 to 4 days of injury were randomized to either the PRICE protocol (Protection, Rest, Ice, Compression, Elevation) combined with non-steroidal anti-inflammatory drugs (NSAIDs) or the PEACE and LOVE rehabilitation framework (Protection, Elevation, Avoid anti-inflammatories, Compression, Education + Load, Optimism, Vascularization, Exercise). Randomization was performed using a computer-generated sequence with concealed envelope allocation. Outcome assessors were blinded to group assignment.
Both groups received initial protection using a lace-up ankle splint, and some participants received temporary plaster cast immobilization in the emergency department based on clinical symptoms. In the PRICE + NSAIDs group, early management focused on rest, cryotherapy, compression, elevation, and scheduled ibuprofen dosing according to body weight. Structured rehabilitation exercises were not introduced during the first 1 to 2 weeks. In the PEACE and LOVE group, cryotherapy and NSAIDs were avoided, and participants received education on tissue healing and early optimal loading. Home exercises included pain-free elastic resistance strengthening and basic balance training starting in the first week, with progressive neuromuscular and aerobic exercise in later phases.
Functional recovery was assessed at 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury. Objective biomechanical outcomes included isokinetic ankle inversion and eversion strength and range of motion measured using a Biodex dynamometer at angular velocities of 60°/s and 120°/s. Dynamic balance was evaluated using the Y-Balance Test. All outcomes were analyzed as side-to-side deficits between the injured and uninjured limbs.
The primary aim of the study was to compare functional recovery between the two treatment protocols over a 12-15-week period. Secondary aims included evaluating changes in dynamic balance, assessing the influence of early immobilization on outcomes, and documenting the time course of strength and mobility restoration. The study was conducted at the Lithuanian University of Health Sciences and received ethics approval prior to initiation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania, LT-44307
- Lithuanian University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 12 to 17 years
First-time lateral ankle sprain
Presentation within 1 to 4 days after injury
No chronic ankle pain prior to the injury
No fracture except minor avulsion fractures confirmed by imaging
Ability to participate in follow-up assessments
Exclusion Criteria:
Previous ankle surgery
History of chronic ankle pain or ankle instability
Systemic diseases (e.g., inflammatory, metabolic, or autoimmune conditions)
Neurological disorders affecting lower-extremity function
Inability to perform isokinetic or balance testing
Declined informed consent by the participant or legal guardian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: PRICE + NSAIDs
Participants received the traditional PRICE protocol (Protection, Rest, Ice, Compression, Elevation) during the acute phase, including rest and limited weight-bearing for 3-5 days based on pain, cryotherapy four times daily for 15-20 minutes, compression, and limb elevation.
Ibuprofen was prescribed three times daily according to body weight.
No structured rehabilitation exercises were introduced during the first 1-2 weeks.
Gradual return to full weight-bearing was allowed as symptoms improved, and a lace-up ankle splint was used during daily activities.
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A conservative management approach consisting of Protection, Rest, Ice, Compression, and Elevation.
Includes scheduled ibuprofen dosing according to body weight for pain and inflammation control.
The intervention focuses on symptom reduction through cryotherapy, activity restriction, and edema management during the early phase of recovery.
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Active Comparator: PEACE and LOVE
Participants received the PEACE and LOVE rehabilitation approach (Protection, Elevation, Avoid anti-inflammatories, Compression, Education + Load, Optimism, Vascularization, Exercise).
Cryotherapy and NSAIDs were avoided, with paracetamol used only for pain control.
Early education on injury healing and self-management was provided.
Pain-free home exercises were initiated during the first week, including elastic resistance strengthening and balance training.
Progressive loading, neuromuscular exercises, aerobic conditioning, and sport-specific drills were added in subsequent phases.
A lace-up ankle splint was used during daily activities.
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A rehabilitation framework emphasizing Protection, Elevation, Avoidance of anti-inflammatories, Compression, and Education, followed by Load, Optimism, Vascularization, and Exercise.
The intervention promotes early optimal loading, pain-free therapeutic exercise, neuromuscular training, and patient education to support tissue healing and functional recovery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in ankle inversion peak torque/body weight (%) deficit between injured and uninjured limbs at 60°/s
Time Frame: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Ankle inversion peak torque normalized to body weight (Peak TQ/BW, %) is measured using a Biodex isokinetic dynamometer at an angular velocity of 60 degrees per second.
For each assessment, peak torque values are collected for the uninjured and injured limbs and used to calculate a side-to-side deficit expressed as a percentage (uninjured minus injured limb).
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1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Y-Balance Test composite score deficit between injured and uninjured limbs
Time Frame: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Dynamic balance is assessed using the Y-Balance Test (YBT).
For each limb, participants perform three maximal reach attempts in the anterior, posteromedial, and posterolateral directions, and a composite score is calculated by normalizing reach distances to limb length and multiplying by 100 percent.
For each time point, a side-to-side deficit is calculated as the difference between the uninjured and injured limbs (uninjured minus injured limb).
The secondary outcome is the change in this composite score deficit over time, comparing recovery between the PRICE + NSAIDs group and the PEACE and LOVE group.
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1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Change in ankle inversion-eversion range of motion (ROM) deficit between injured and uninjured limbs
Time Frame: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Ankle inversion and eversion range of motion (ROM, degrees) is measured using a Biodex isokinetic dynamometer at angular velocities of 60 degrees per second and 120 degrees per second.
At each testing session, ROM is recorded for the uninjured and injured limbs, and a side-to-side deficit is calculated as the difference between limbs (uninjured minus injured limb).
The secondary outcome is the change in ROM deficit over time at both testing velocities, comparing recovery between the PRICE + NSAIDs group and the PEACE and LOVE group.
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1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in ankle inversion peak torque/body weight (%) deficit at 120°/s
Time Frame: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Inversion peak torque normalized to body weight (Peak TQ/BW, %) is measured using a Biodex isokinetic dynamometer at an angular velocity of 120 degrees per second.
For each testing session, peak torque values are recorded for the uninjured and injured limbs, and a side-to-side deficit is calculated (uninjured minus injured limb).
This outcome evaluates changes in inversion strength deficit at the higher testing velocity over time.
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1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Change in ankle eversion peak torque/body weight (%) deficit at 60°/s and 120°/s
Time Frame: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
|
Ankle eversion peak torque normalized to body weight (Peak TQ/BW, %) is measured using a Biodex isokinetic dynamometer at angular velocities of 60 degrees per second and 120 degrees per second.
For each velocity and at each time point, peak torque values for the uninjured and injured limbs are compared to calculate a side-to-side deficit (uninjured minus injured limb).
This outcome evaluates changes in eversion strength deficit at both testing velocities over the course of rehabilitation.
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1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
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Collaborators and Investigators
Investigators
- Principal Investigator: Matas Meskauskas, Lithuanian University of Health Sciences
- Study Director: Emilis Cekanauskas, Professor, Lithuanian University of Health Sciences
Publications and helpful links
General Publications
- Meškauskas M, Rutkauskas S, Misiūnienė M, Žumbakys J, Tomkevičiūtė J, Malcius D, Čekanauskas E. PRICE vs PEACE and LOVE in adolescent lateral ankle sprain rehabilitation: a prospective comparative study of muscle strength and dynamic balance.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-LSMU-LAS-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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