PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation: a Prospective Comparative Study of Muscle Strength and Dynamic Balance.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Change in ankle inversion peak torque/body weight (%) deficit between injured and uninjured limbs at 60°/s
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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).
Secondary Outcomes
- 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)
Investigators
Matas Meškauskas
Pediatric Orthopedic Surgeon, Lithuanian University of Health Sciences
Lithuanian University of Health Sciences