Lateral Ankle SprainNCT07287020
PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation
A study testing PRICE + NSAIDs protocol and PEACE and LOVE protocol in people with Lateral Ankle Sprain and Ankle Injuries, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Lateral Ankle Sprain, Ankle Injuries, Sprain of Lateral Ligament
- What is being tested?
- PRICE + NSAIDs protocol and PEACE and LOVE protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteLithuania
- Study dates
- 2 Feb 2022to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation: a Prospective Comparative Study of Muscle Strength and Dynamic Balance.
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.
Read the 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
- Lateral Ankle Sprain, Ankle Injuries, Sprain of Lateral Ligament, Rupture of Ligaments at Ankle and Foot Level
- Being tested
- PRICE + NSAIDs protocol, PEACE and LOVE protocol
- Keywords
- PRICE protocol, PEACE and LOVE protocol, Ankle sprain rehabilitation, Y-Balance Test, Biodex isokinetic testing
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRICE + NSAIDs protocolBehavioural
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 protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PEACE and LOVE protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 1-2 weeks, 5-7 weeks, and 12-15 weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Feb 2022
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matas Meškauskas, Lithuanian University of Health Sciences
- Investigators
- Matas Meskauskas, Principal investigator, Lithuanian University of Health SciencesEmilis Cekanauskas, Professor, Study director, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287020
- Sponsor's protocol ID
- MM-LSMU-LAS-Study
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified datasets may be made available upon reasonable request to the corresponding author, subject to institutional approval and data protection regulations.
Publications
Meskauskas M, Rutkauskas S, Misiuniene M, Zumbakys J, Tomkeviciute J, Malcius D, Cekanauskas E. PRICE (Protection, Rest, Ice, Compression, Elevation) vs. PEACE and LOVE (Protection, Elevation, Avoid anti-inflammatories, Compression, Education and Load, Optimism, Vascularization, Exercise) in adolescent lateral ankle sprain rehabilitation: a randomized prospective comparative study of muscle strength and dynamic balance. BMC Sports Sci Med Rehabil. 2026 Mar 17;18(1):213. doi: 10.1186/s13102-026-01651-7.
PubMed 41840451Meskauskas M, Rutkauskas S, Misiuniene M, Tomkeviciute J, Kriauzaite P, Malcius D, Cekanauskas E. Association between injury severity and recovery of objective functional measures following adolescent lateral ankle sprain: a secondary cohort analysis. Front Sports Act Living. 2026 Oct 8;8:1966025. doi: 10.3389/fspor.2026.1966025. eCollection 2026.
PubMed 42923265
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRICE vs PEACE and LOVE in Adolescent Lateral Ankle Sprain Rehabilitation: a Prospective Comparative Study of Muscle Strength and Dynamic Balance.
- ClinicalTrials.gov ID
- NCT07287020
- Acronym / sponsor ID
- MM-LSMU-LAS-Study
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRICE + NSAIDs | Active comparator | Behavioral: PRICE + NSAIDs protocolParticipants 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. |
| PEACE and LOVE | Active comparator | Behavioral: PEACE and LOVE protocolParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRICE + NSAIDs protocolA 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. | Behavioural | PRICE + NSAIDs |
| PEACE and LOVE protocolA 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. | Behavioural | PEACE and LOVE |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 41840451Meskauskas M, Rutkauskas S, Misiuniene M, Zumbakys J, Tomkeviciute J, Malcius D, Cekanauskas E. PRICE (Protection, Rest, Ice, Compression, Elevation) vs. PEACE and LOVE (Protection, Elevation, Avoid anti-inflammatories, Compression, Education and Load, Optimism, Vascularization, Exercise) in adolescent lateral ankle sprain rehabilitation: a randomized prospective comparative study of muscle strength and dynamic balance. BMC Sports Sci Med Rehabil. 2026 Mar 17;18(1):213. doi: 10.1186/s13102-026-01651-7.
- Derived from this study: PubMed 42923265Meskauskas M, Rutkauskas S, Misiuniene M, Tomkeviciute J, Kriauzaite P, Malcius D, Cekanauskas E. Association between injury severity and recovery of objective functional measures following adolescent lateral ankle sprain: a secondary cohort analysis. Front Sports Act Living. 2026 Oct 8;8:1966025. doi: 10.3389/fspor.2026.1966025. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified datasets may be made available upon reasonable request to the corresponding author, subject to institutional approval and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matas Meskauskas principal investigator
Lithuanian University of Health Sciences
Emilis Cekanauskas, Professor study director
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRICE + NSAIDs protocol and PEACE and LOVE protocol in people with Lateral Ankle Sprain and Ankle Injuries, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07287020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.