PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation
NCT ID: NCT07287020
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2022-02-02
2025-01-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
PRICE + NSAIDs protocol
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.
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.
PEACE and LOVE protocol
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.
Interventions
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PRICE + NSAIDs protocol
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.
PEACE and LOVE protocol
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.
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
17 Years
ALL
No
Sponsors
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Lithuanian University of Health Sciences
OTHER
Responsible Party
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Matas Meškauskas
Pediatric Orthopedic Surgeon, Lithuanian University of Health Sciences
Principal Investigators
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Matas Meskauskas
Role: PRINCIPAL_INVESTIGATOR
Lithuanian University of Health Sciences
Emilis Cekanauskas, Professor
Role: STUDY_DIRECTOR
Lithuanian University of Health Sciences
Locations
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Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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References
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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.
Other Identifiers
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MM-LSMU-LAS-Study
Identifier Type: -
Identifier Source: org_study_id