PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation

NCT07287020 | Completed

• 1 other identifier: MM-LSMU-LAS-Study
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Ankle Sprain; Ankle Injuries; Sprain of Lateral Ligament; Rupture of Ligaments at Ankle and Foot Level

Keywords

PRICE protocol; PEACE and LOVE protocol; Ankle sprain rehabilitation; Y-Balance Test; Biodex isokinetic testing

Outcome Measures

Primary Outcomes (1)

• Change in ankle inversion peak torque/body weight (%) deficit between injured and uninjured limbs at 60°/s

  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).

  1-2 weeks, 5-7 weeks, and 12-15 weeks after injury

Secondary Outcomes (2)

• Change in Y-Balance Test composite score deficit between injured and uninjured limbs

  1-2 weeks, 5-7 weeks, and 12-15 weeks after injury

• Change in ankle inversion-eversion range of motion (ROM) deficit between injured and uninjured limbs

  1-2 weeks, 5-7 weeks, and 12-15 weeks after injury

Other Outcomes (2)

• Change in ankle inversion peak torque/body weight (%) deficit at 120°/s

  1-2 weeks, 5-7 weeks, and 12-15 weeks after injury

• Change in ankle eversion peak torque/body weight (%) deficit at 60°/s and 120°/s

  1-2 weeks, 5-7 weeks, and 12-15 weeks after injury

Study Arms (2)

PRICE + NSAIDs

ACTIVE COMPARATOR

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.

Behavioral: PRICE + NSAIDs protocol

PEACE and LOVE

ACTIVE COMPARATOR

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.

Behavioral: PEACE and LOVE protocol

Interventions

PRICE + NSAIDs protocol BEHAVIORAL

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.

PRICE + NSAIDs

PEACE and LOVE protocol BEHAVIORAL

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.

PEACE and LOVE

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-44307, Lithuania

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Commerce

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• Matas Meskauskas

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Emilis Cekanauskas, Professor

  Lithuanian University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors performing ultrasound imaging, isokinetic strength testing, and Y-Balance assessments were blinded to treatment allocation. Participants and treating clinicians were not blinded due to the nature of the rehabilitation protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Surgeon, Lithuanian University of Health Sciences

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two treatment groups using a computer-generated simple randomization sequence with concealed envelope allocation. Each participant received only the intervention assigned at randomization, and no crossover occurred between groups. Both groups were followed in parallel for the full study period, and outcome assessors were blinded to group assignment.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: February 2, 2022
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)