Trials / Completed

CompletedNCT07287020

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.

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 76 (actual)

Sponsor: Lithuanian University of Health Sciences · Academic / Other
Sex: All
Age: 12 Years – 17 Years
Healthy volunteers: Not accepted

Summary

This study compared two early management strategies for adolescents with first-time lateral ankle sprain: the traditional PRICE protocol (Protection, Rest, Ice, Compression, Elevation) combined with non-steroidal anti-inflammatory drugs (NSAIDs) and the PEACE and LOVE rehabilitation framework (Protection, Elevation, Avoid anti-inflammatories, Compression, Education + Load, Optimism, Vascularization, Exercise). Seventy-six participants aged 12-17 years were randomized to one of the two treatment groups and followed for 12-15 weeks. Functional recovery was assessed at three time points using isokinetic dynamometry to measure ankle inversion and eversion strength, and the Y-Balance Test to evaluate dynamic balance. The study aimed to determine whether the PEACE and LOVE approach resulted in superior improvements in neuromuscular function compared to PRICE + NSAIDs. Outcomes were analyzed as side-to-side deficits between the injured and uninjured limbs.

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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

Start date: 2022-02-02
Primary completion: 2025-01-14
Completion: 2025-01-14
First posted: 2025-12-16
Last updated: 2025-12-23

Locations

1 site across 1 country: Lithuania

Source: ClinicalTrials.gov record NCT07287020. Inclusion in this directory is not an endorsement.