A Prospective, Multi-Site, Interventional Case-Series Evaluating the MOVE (Movement-Oriented Velocity of Engagement) Protocol for Musculoskeletal Pain Recovery
Phase: NA
Conditions: Musculoskeletal Pain - Acute and Subacute Conditions
Sponsor: MMSx Authority Institute for Movement Mechanics and Biomechanics Research Inc

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​Clinical Study Protocol | MOVE-001/2025 | Version 1.0 | June 15 2024​
​MMSx Authority – Institute for Movement Mechanics & Biomechanics Research​
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​CLINICAL STUDY PROTOCO​L​
​Protocol ID:​​MOVE-001/2025​​| Version 1.0 | Date:​
​June 15, 2024​
​Official Title:​​Movement-Oriented Velocity of​
​Engagement (MOVE) Protocol​
​Sponsor:​​MMSx Authority – Institute for Movement​
​Mechanics & Biomechanics Research​
​Principal Investigator:​​Dr. Neeraj Mehta, Ph.D.​
​(Biomechanics & Alternative Medicine)​
​Organization Address:​​940 Vauxhill Lane, Powell,​
​Ohio 43065, USA​
​Contact Email:​​info@mmsxauthority.com​
​Confidential – For Research Use Only | © 2025 MMSx​
​Authority | All Rights Reserved​

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​CLINICAL STUDY PROTOCOL: MOVE-001/2025​
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​Protocol Title: A Prospective, Multi-Site, Interventional Case-Series to​
​Evaluate the M.O.V.E. Protocol for the Management of Acute and Subacute​
​Musculoskeletal Conditions.​
​IMSO-​REG-20251021-PM-6994-A​
​Prepared by:​​MMSx Authority Clinical Research Division​
​Field​
​Correct​
​Entry​
​Rationale​
​Study Start Date​
​June 2024​
​The first participant was enrolled.​
​Primary​
​Completion Date​
​September​
​2024​
​Month the last participant finished​
​follow-up.​
​Study Completion​
​Date​
​October 2024​ ​Data cleaning & analysis finished.​
​Protocol Version​
​Date​
​17 October​
​2025​
​Date the finalized, approved version​
​was signed & archived.​
​Recruitment​
​Status​
​Completed​
​Trial completed at all sites.​
​Protocol Identifier: MOVE-001/2025​
​Version: 1.0​
​Protocol Finalization Date: October 17, 2025​
​Sponsor:​
​MMSX AUTHORITY INSTITUTE FOR MOVEMENT MECHANICS & BIOMECHANICS RESEARCH,INC.​
​940 VAUXHILL LANE POWELL, OH 43065​
​[6148228038]​
​Coordinating Principal Investigator:​
​Dr. Neeraj Mehta, Ph.D. (Biomechanics & Alternative Medicine)​
​Founder, MMSx Authority​
​Global Head, GFFI (India)​
​ORCID ID: https://orcid.org/​0000-0001-6200-8495​

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​SIGNATURE PAGE​
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​By signing below, I acknowledge that I have read and understood the protocol and agree to​
​conduct the study in compliance with all its stipulations, Good Clinical Practice (GCP),​
​and all applicable regulatory requirements.​
​Coordinating Principal Investigator:​
​_______________________________​
​Dr. Neeraj Mehta, Ph.D.​
​Date: ______________________​
​ORCID ID: https://orcid.org/0000-0001-6200-8495​
​Head of Clinical Operations:​
​_______________________________​
​Sunita Mathotra (NIH/GCP)​
​Date: ______________________​

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​TABLE OF CONTENTS​
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​1.  List of Abbreviations​
​2.  Protocol Synopsis​
​3.  Introduction: Background & Rationale​
​4.  Study Objectives and Endpoints​
​5.  Study Design​
​6.  Subject Selection and Withdrawal​
​7.  Study Intervention​
​8.  Study Assessments and Procedures​
​9.  Statistical Methods​
​10. Quality Control and Quality Assurance​
​11. Ethics and Regulatory Compliance​
​12. Data Handling and Record Keeping​
​13. Study Governance and Personnel​
​14. Publication and Dissemination Policy​
​15. References​
​16. Appendices​

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​1. LIST OF ABBREVIATIONS​
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​AE          Adverse Event​
​AROM        Active Range of Motion​
​CFR         Code of Federal Regulations​
​CI          Confidence Interval​
​CRF         Case Report Form​
​DOMS        Delayed Onset Muscle Soreness​
​ECDF        Empirical Cumulative Distribution Function​
​GCP         Good Clinical Practice​
​GROC        Global Rating of Change​
​HRR         Heart Rate Recovery​
​HSP         Human Subjects Protection​
​ICH         International Council for Harmonisation​
​IMSO        International Musculoskeletal Organisation​
​IREB        Institutional Review and Ethics Board​
​ISRCTN      International Standard Randomised Controlled Trial Number​
​LEFS        Lower Extremity Functional Scale​
​LOCF        Last Observation Carried Forward​
​MCID        Minimal Clinically Important Difference​
​M.O.V.E.    Movement-Oriented Velocity of Engagement​
​MSK         Musculoskeletal​
​NIH         National Institutes of Health​
​NRS         Numeric Rating Scale​
​ORCID       Open Researcher and Contributor ID​
​QA          Quality Assurance​
​RCT         Randomized Controlled Trial​
​RPE         Rating of Perceived Exertion​
​SAE         Serious Adverse Event​
​SD          Standard Deviation​
​SLS         Single-Leg Stance​
​SOP         Standard Operating Procedure​
​STS         Sit-to-Stand​
​UEFI        Upper Extremity Functional Index​
​WHO         World Health Organization​

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​2. PROTOCOL SYNOPSIS​
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​Title:​
​A Prospective, Multi-Site, Interventional Case-Series to Evaluate the M.O.V.E. Protocol for​
​the Management of Acute and Subacute Musculoskeletal Conditions.​
​Study Design:​
​A prospective, multi-site, single-arm, interventional case-series with an 8-week follow-up​
​period. This study serves as a feasibility and pilot investigation.​
​Population:​
​Adults aged 18–70 with acute or subacute (<12 weeks) musculoskeletal pain of mechanical​
​origin, with a baseline pain score of ≥4 on a 0-10 Numeric Rating Scale (NRS).​
​Intervention:​
​The M.O.V.E. (Mobilize, Optimize, Validate, Energize) protocol, a criterion-based,​
​progressive activity and mechanotherapy program delivered over 8 weeks.​
​Primary Objective:​
​To assess the feasibility and safety of the M.O.V.E. protocol and to evaluate its effect on​
​pain reduction.​
​Primary Endpoint:​
​Change in pain intensity from Baseline to Week 8, as measured by the Numeric Rating Scale​
​(NRS).​
​Secondary Endpoints:​
​- Change in function (LEFS/UEFI)​
​- Change in balance (SLS)​
​- Change in functional strength (STS)​
​- Global Rating of Change (GROC)​
​- Time to return to Activities of Daily Living (ADL)​
​- Adherence to the protocol​
​- Incidence of Adverse Events (AEs)​
​Sample Size:​
​A pragmatic sample of approximately 40 participants will be recruited across 5​
​international sites for this feasibility study.​
​Study Duration:​
​Each participant will be in the study for 8 weeks.​

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​3. INTRODUCTION: BACKGROUND & RATIONALE​
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​Musculoskeletal (MSK) conditions represent a leading cause of disability worldwide,​
​imposing a significant burden on individuals and healthcare systems. Traditional management​
​for many acute and subacute MSK injuries has often included periods of rest,​
​immobilization, and modalities such as icing (cryotherapy). However, a growing body of​
​evidence suggests that this approach may be suboptimal [1]. Prolonged rest can lead to​
​muscle atrophy, joint stiffness, and impaired neuromuscular control, while the routine use​
​of cryotherapy is being questioned for its potential to blunt the natural inflammatory and​
​regenerative processes essential for optimal tissue healing [2].​
​This paradigm shift is rooted in the principles of mechanotransduction, the process by​
​which cells convert mechanical stimuli into biochemical responses [3]. Early, controlled​
​loading and movement provide the necessary signals to guide the organization and remodeling​
​of healing tissues, such as collagen fibers in tendons and ligaments. The absence of these​
​mechanical signals can result in disorganized, weaker scar tissue and a delayed functional​
​recovery.​
​The M.O.V.E. (Movement-Oriented Velocity of Engagement) protocol is a structured,​
​multi-faceted intervention designed to operationalize these modern principles. It​
​represents a departure from the passive, rest-focused model towards an early,​
​criterion-based application of progressive activity. The protocol is built on four​
​interdependent pillars:​
​1. Mobilize: Initiates early, pain-free movement to reduce arthrogenic muscle inhibition,​
​improve synovial fluid circulation, and maintain neural pathway integrity.​
​2. Optimize: Applies progressive mechanical loads to stimulate tissue adaptation and​
​remodeling, moving systematically from isometric to complex functional movements based on​
​tissue tolerance.​
​3. Validate: Focuses on restoring neuromuscular control, proprioception, and balance to​
​ensure that movement quality is high and compensatory patterns are minimized.​
​4. Energize: Incorporates low-intensity cardiovascular activity to enhance systemic​
​circulation, improve metabolic efficiency, and support the energetic demands of tissue​
​repair and recovery.​
​This prospective, multi-site case-series (MOVE-001/2025) is designed as a crucial first​
​step to formally evaluate the feasibility, safety, and preliminary efficacy of the M.O.V.E.​
​protocol in a real-world clinical setting across diverse patient populations and​
​international sites. The findings will provide the foundational data required to design​
​future large-scale randomized controlled trials (RCTs).​

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​4. STUDY OBJECTIVES AND ENDPOINTS​
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​4.1 PRIMARY OBJECTIVE​
​To assess the feasibility of implementing the M.O.V.E. protocol across multiple clinical​
​sites and to evaluate its preliminary efficacy in reducing pain in individuals with MSK​
​conditions.​
​Primary Endpoint:​
​Change in Pain (NRS): The absolute change in the 11-point Numeric Rating Scale (NRS) for​
​pain from Baseline to Week 8. A Minimal Clinically Important Difference (MCID) is defined​
​as a reduction of ≥2 points [4].​
​4.2 SECONDARY OBJECTIVES​
​- To evaluate the effect of the M.O.V.E. protocol on physical function, balance, and​
​strength.​
​- To assess patient-reported outcomes of recovery and treatment satisfaction.​
​- To characterize the safety profile of the intervention.​
​- To quantify patient adherence to the home-based components of the protocol.​
​Secondary Endpoints:​
​- Functional Improvement: Change in the Lower Extremity Functional Scale (LEFS) or Upper​
​Extremity Functional Index (UEFI) score from Baseline to Week 4 and Week 8. The MCID is 9​
​points [5].​
​- Balance: Change in Single-Leg Stance (SLS) time (in seconds) from Baseline to Week 8.​
​- Functional Strength: Change in the number of repetitions completed in the 30-second​
​Sit-to-Stand (STS) test from Baseline to Week 8.​
​- Global Perceived Effect: Score on the Global Rating of Change (GROC) scale at Week 8.​
​- Time to Recovery: Time (in days) from enrollment to return to full, unrestricted​
​Activities of Daily Living (ADL) and, for a subset, return to sport.​
​- Adherence: Percentage of prescribed home exercise sessions completed, tracked via patient​
​logs and verified by clinicians.​
​- Safety: Incidence, nature, and severity of all Adverse Events (AEs) and Serious Adverse​
​Events (SAEs).​

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​5. STUDY DESIGN​
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​This is a prospective, multi-site, single-arm, interventional case-series designed to​
​assess a standardized clinical protocol. The study will be conducted at five international​
​sites, including academic labs, private clinics, and community-based centers.​
​Participants will undergo a screening and baseline assessment, after which they will​
​receive the 8-week M.O.V.E. protocol intervention. Follow-up assessments will be conducted​
​at Week 2, Week 4, and Week 8.​
​The study design was chosen to establish initial proof-of-concept, assess feasibility, and​
​generate hypotheses for a subsequent, more definitive RCT. The single-arm design is​
​appropriate for this early phase of investigation where the primary goal is to observe the​
​response to a novel, standardized intervention.​
​Figure 1: Pain Trajectory - Preliminary data from an initial pilot cohort (n=6) showing the​
​expected pain trajectory (see attached graphs).​
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​6. SUBJECT SELECTION AND WITHDRAWAL​
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​6.1 INCLUSION CRITERIA​
​1. Male or female, aged 18 to 70 years, inclusive.​
​2. Presenting with a primary complaint of musculoskeletal pain (e.g., lumbar strain, ankle​
​sprain, shoulder impingement-related pain, patellofemoral pain).​
​3. Acute or subacute symptom duration of less than 12 weeks.​

​4. Baseline pain intensity of ≥4 on the 11-point NRS.​
​5. Able and willing to provide written informed consent and to comply with all study​
​procedures and visits.​
​6.2 EXCLUSION CRITERIA​
​1. Presence of any "red flag" conditions requiring immediate medical referral (e.g.,​
​suspected fracture, cauda equina syndrome, tumor, systemic inflammatory disease).​
​2. Confirmed complete tissue rupture (e.g., Grade III ligament tear, complete tendon​
​rupture).​
​3. Major or progressive neurological deficit.​
​4. Uncontrolled or unstable medical comorbidities (e.g., cardiovascular, metabolic, or​
​psychological conditions) that would preclude safe participation in an exercise-based​
​protocol.​
​5. Pregnancy.​
​6. Involvement in another interventional clinical trial concurrently or within the past 30​
​days.​
​7. Inability to understand and follow instructions in the primary language of the clinical​
​site.​
​6.3 SUBJECT WITHDRAWAL​
​Subjects may be withdrawn from the study at any time for the following reasons:​
​- Voluntary withdrawal by the subject.​
​- A significant AE or intercurrent illness that, in the investigator's opinion, warrants​
​discontinuation.​
​- Failure to adhere to protocol requirements.​
​- The investigator deems it is not in the subject's best interest to continue.​
​All withdrawn subjects will be followed up for safety outcomes, and the reason for​
​withdrawal will be documented in the Case Report Form (CRF).​

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​7. STUDY INTERVENTION​
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​The M.O.V.E. protocol is a multi-modal program administered over 8 weeks. It is not a rigid​
​prescription but a criterion-based framework guided by patient tolerance and functional​
​progression. All participating clinicians will undergo standardized training on the​
​protocol's principles and application.​
​MOVE DOSAGE & PROGRESSION GATES​
​Domain: M -- Mobilize Early​
​Prescription (Real-World): Pain-free AROM, joint oscillations, breath-led mobility 5–10​
​min, 3–5×/day; grade I–II tissue glides​
​Progression Gate: No sharp/tearing pain; no swelling >24h; technique clean​
​Domain: O -- Optimize Load​
​Prescription (Real-World): Isometric → isotonic → tempo/eccentric; RPE 2–4 → 4–6;​
​2–3×8–15; 48-h flare rule​
​Progression Gate: DOMS ≤48h; movement control; pain ≤3/10 during/after​
​Domain: V -- Validate Neural Control​
​Prescription (Real-World): Balance/proprioception, perturbations, step-downs, hop-prep​
​10–15 min/session​
​Progression Gate: Stable mechanics (no valgus/collapse); task competence​
​Domain: E -- Energize Recovery​
​Prescription (Real-World): Nasal breathing + brisk walk/cycle, Zone 2–3, 20–30 min, 3–5​
​d/wk​
​Progression Gate: HRR improving; no symptom spike >24h​
​PROGRESSION GATES AND DELOADING​

​Progression from one phase to the next within each domain is governed by explicit criteria​
​(Progression Gates). If a patient experiences a symptom flare (e.g., pain increase >2​
​points on NRS lasting >24 hours, significant increase in swelling), a mandatory 48-hour​
​deload is initiated, where activity is reduced to the last tolerated level.​

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​8. STUDY ASSESSMENTS AND PROCEDURES​
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​8.2 SAFETY MONITORING AND REPORTING​
​Adverse Event (AE): Any untoward medical occurrence in a patient administered a study​
​intervention, which does not necessarily have a causal relationship with this treatment.​
​Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires​
​inpatient hospitalization, results in persistent or significant disability/incapacity, or​
​is a congenital anomaly/birth defect.​

​All AEs and SAEs, whether observed by the investigator or reported by the subject, will be​
​recorded in the subject's CRF. All SAEs must be reported to the Sponsor-Investigator and​
​the Institutional Review and Ethics Board (IREB) within 24 hours of the site becoming aware​
​of the event.​
​Figure 2: Adverse Events Profile - Safety profile from the initial pilot cohort shows a​
​favorable safety profile with no serious adverse events (see attached graphs).​

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​9. STATISTICAL METHODS​
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​9.1 STATISTICAL ANALYSIS PLAN​
​All statistical analyses will be performed by a central, independent biostatistician. The​
​primary analysis will be descriptive and exploratory, consistent with the goals of a​
​feasibility study.​
​- Descriptive Statistics: Continuous variables will be summarized using means, standard​
​deviations (SD), medians, and interquartile ranges (IQR). Categorical variables will be​
​summarized using frequencies and percentages.​
​- Primary Endpoint Analysis: The within-subject change in Pain NRS from Baseline to Week 8​
​will be calculated. The mean change with a 95% confidence interval (CI) will be estimated​
​using bootstrapping (1,000 resamples) to account for the non-normal distribution of change​
​scores.​
​- Secondary Endpoint Analysis: Similar within-subject change scores and 95% CIs will be​
​calculated for LEFS/UEFI, SLS, and STS.​
​- Time-to-Event Analysis: Time-to-ADL recovery will be visualized using an Empirical​
​Cumulative Distribution Function (ECDF) curve.​
​- Subgroup Analysis: Exploratory analyses will compare outcomes between clinical sites.​
​Cohen's d effect sizes will be calculated for the change in pain to assess the magnitude of​
​improvement at each site.​
​Figure 3: Effect Size by Site - Cohen's d effect sizes for pain improvement across​
​different clinical sites (see attached graphs).​

​9.2 SAMPLE SIZE DETERMINATION​
​As this is a feasibility and pilot study, a formal, power-based sample size calculation is​
​not appropriate. A pragmatic sample size of approximately 40 participants (n≈8 per site) is​
​considered sufficient to assess the feasibility of recruitment, protocol implementation,​
​and to generate stable estimates of the means and variances of the outcome measures. These​
​estimates will be used to power a future, definitive RCT.​

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​10. QUALITY CONTROL AND QUALITY ASSURANCE​
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​To ensure the quality and integrity of the study data, the following measures will be​
​implemented:​
​- Standard Operating Procedures (SOPs): All sites will operate under a common set of SOPs​
​for participant recruitment, informed consent, data collection, and intervention delivery.​
​- Investigator Training: All site investigators and clinical staff will attend a mandatory​
​study initiation meeting for comprehensive training on the protocol and all study​
​procedures.​
​- Site Monitoring: A clinical research associate (CRA) will conduct on-site monitoring​
​visits (initiation, interim, and close-out) to perform source data verification (SDV) on a​
​subset of CRFs, ensure regulatory compliance, and resolve any queries.​
​- Centralized Data Management: All data will be entered into a centralized, secure,​
​GCP-compliant electronic data capture (EDC) system. Automated edit checks will be built in​
​to minimize data entry errors.​

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​11. ETHICS AND REGULATORY COMPLIANCE​
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​This study will be conducted in full compliance with the principles of the Declaration of​
​Helsinki (2013), the International Council for Harmonisation (ICH) E6(R2) Good Clinical​
​Practice guidelines, and all applicable national and local regulations (e.g., US DHHS 45​
​CFR 46).​
​11.1 INSTITUTIONAL REVIEW AND ETHICS BOARD (IREB)​
​The protocol, informed consent form, and all other relevant study documents will be​
​submitted to the MMSx Authority central IREB for review and approval. The study will not​
​commence at any site until written approval from the IREB has been obtained. Each site will​
​also be responsible for obtaining approval from their local IRB/IEC, if required.​
​11.2 INFORMED CONSENT​
​Written, informed consent must be obtained from each participant before any study-specific​
​procedures are performed. The informed consent process will be conducted by a qualified​
​investigator or designee, who will explain the study's purpose, procedures, risks, and​
​benefits in non-technical language.​
​11.3 CONFIDENTIALITY​
​All participant information will be kept strictly confidential. Participants will be​
​assigned a unique identification number, and all study records and datasets will use this​
​identifier. Documents linking names to identifiers will be stored separately in a secure,​
​locked location.​

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​12. DATA HANDLING AND RECORD KEEPING​
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​Data will be collected on standardized paper or electronic Case Report Forms (CRFs). All​
​source documents and CRFs will be retained at the investigational sites in a secure​
​location for a minimum of 5 years after study completion, or as required by local​
​regulations. An audit trail will be maintained for all data changes in the EDC system.​
​Data Availability: In accordance with open science principles, a de-identified dataset and​
​the full statistical analysis plan will be made available upon reasonable request to the​
​corresponding author, following publication of the primary results and with authorization​
​from the IREB.​

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​13.1 Study Governance and Site Personnel Roster​
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​GLOBAL LEADERSHIP​
​Coordinating Principal Investigator​
​Dr. Neeraj Mehta, Ph.D. (Biomechanics & Alternative Medicine)​
​MMSx Authority & GFFI​
​Responsible for overall scientific direction, protocol integrity, and publication​
​approval.​
​Head of Clinical Operations & Ethics Chair​
​Sunita Malhotra, NIH / GCP Certified​
​MMSx IREB​​— Ethical compliance, safety monitoring,​​and regulatory reporting.​
​Lead Scientific Advisor​
​Dr. Umesh Kumar, Ph.D. (Kinesiology)​
​IGPEI – India​​— Methodological and translational​​guidance in kinesiology research.​
​Lead Biostatistician​
​Dr. Ben Carter, Ph.D. (Biostatistics)​
​MMSx Authority Statistics Core​​— Statistical design,​​data analysis, and validation.​
​Global Research Coordinator​
​Sumit Khoney, MMSx Pro / CPT (Biomechanics)​
​MMSx Authority​​— Site communication, data tracking,​​and training coordination.​
​RESEARCH SITES AND PERSONNEL​
​SITE 1 — MMSx AUTHORITY (COORDINATING CENTER)​
​Powell, Ohio, USA​
​Principal Investigator:​​Dr. Neeraj Mehta, Ph.D.​
​Affiliation:​​MMSx Authority Institute for Movement​​Mechanics & Biomechanics Research​
​Status:​​Completed​
​Responsibilities:​​Global coordination, ethics oversight​​(IREB), data management, and​
​central analysis.​
​SITE 2 — BODYGNTX (USA)​
​Powell, Ohio, USA​
​Site PI:​​Dr. John Davis, DPT, OCS​
​Coordinator:​​Sarah Chen, B.S., CCRP​
​Status:​​Completed​
​Responsibilities:​​U.S. participant recruitment, rehabilitation​​implementation, and data​
​reporting.​
​SITE 3 — GFFI FITNESS ACADEMY (INDIA)​
​New Delhi, India​
​Site PI:​​Pankaj Mehta, M.P.Ed., ACE-Certified, CTO​​(JHU)​
​Coordinator:​​Priya Sharma, BPT​

​Status:​​Completed​
​Responsibilities:​​Participant engagement, MOVE protocol delivery, and site-level​
​reporting.​
​SITE 4 — IIKBS (AFFILIATE RESEARCH SITE)​
​Pune, India​
​Site PI:​​Dr. Anya Petrova, M.D., Ph.D. (Sports Medicine)​
​Coordinator:​​David Lee, M.Sc.​
​Status:​​Completed​
​Responsibilities:​​Applied biomechanics testing, data​​validation, and collaboration with​
​the central analysis unit.​
​Documentation and Compliance​
​A comprehensive roster of all investigators, coordinators, and technical staff is​
​maintained in the​​MMSx Authority Master Study File​​and includes:​
​●​
​Delegation of Duties Log​
​●​
​Signature Log​
​●​
​Training Records (ICH-GCP, NIH, MMSx Authority Internal Compliance)​
​●​
​Site Initiation and Monitoring Reports​
​All ethical and procedural records are retained for ≥ 5 years post-completion in accordance​
​with​​FDA 21 CFR 312​,​​45 CFR 46​, and​​ICH-GCP archival​​requirements​.​
​Note: All MMSx IREB approvals, delegation logs, and signature attestations for the above​
​personnel are archived in the MMSx Authority Central Master File and available upon​
​request.​

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​14. PUBLICATION AND DISSEMINATION POLICY​
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​The results of this study will be submitted for publication in a peer-reviewed scientific​
​journal, regardless of the outcome. Authorship will be determined in accordance with the​
​International Committee of Medical Journal Editors (ICMJE) criteria. The findings will also​
​be presented at national and international scientific conferences.​
​Trial Registration: This trial will be registered on multiple international platforms prior​
​to the enrollment of the first participant, including ISRCTN, ClinicalTrials.gov (for NIH),​
​and the WHO International Clinical Trials Registry Platform (ICTRP).​
​Suggested Citation: Mehta N, Sunita M, Kumar U, et al. A Prospective, Multi-Site,​
​Interventional Case-Series to Evaluate the M.O.V.E. Protocol for the Management of Acute​
​and Subacute Musculoskeletal Conditions. MMSx Authority Journal. 2025; Vol 1, Issue 1. DOI:​
​[Pending].​

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​15. REFERENCES​
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​1. Dubois B, Esculier JF. Soft-tissue injuries simply need PEACE and LOVE. British Journal​
​of Sports Medicine. 2020;54:72-73.​
​https://bjsm.bmj.com/content/54/2/72​
​2. Singh DP, Barani Lonbani Z, Woodruff MA, Parker TJ, Steck R, Peake JM. Effects of​
​Topical Icing on Inflammation, Angiogenesis, Revascularization, and Myofiber Regeneration​
​in Skeletal Muscle Following Contusion Injury. Frontiers in Physiology. 2017;8:93.​
​https://www.frontiersin.org/articles/10.3389/fphys.2017.00093/full​
​3. Khan KM, Scott A. Mechanotherapy: how physical therapists' prescription of exercise​
​promotes tissue repair. British Journal of Sports Medicine. 2009;43:247-252.​
​https://bjsm.bmj.com/content/43/4/247​
​4. McAuley JH, et al. Minimal clinically important difference in pain and function​
​outcomes. (context for graded loading) Journal of Pain. 2014;15(3):264-71.​
​5. Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale​
​(LEFS): scale development, measurement properties, and clinical application. Physical​
​Therapy. 1999;79(4):371-83.​
​6. International Council for Harmonisation. ICH Harmonised Guideline: Integrated Addendum​
​to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). 2016.​
​https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf​
​7. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical​
​Research Involving Human Subjects. 2013.​
​https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medica​
​l-research-involving-human-subjects/​

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​16. APPENDICES​
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​Appendix A: Sample Informed Consent Form​
​Appendix B: Standard Operating Procedure for Outcome Measure Administration​
​Appendix C: Sample Case Report Form (CRF)​
​Appendix D: Home Program Templates and Patient Adherence Log​
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​END OF PROTOCOL DOCUMENT​
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