Efficacy of the Transition of the Foot Strike Pattern on Pain and Disability in Cadets With Musculoskeletal Pain

NCT04166136 | Terminated

• 1 other identifier: TFSP
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the efficacy of the footstrike pattern transition from rearfoot to midfoot / forefoot pattern compared to lower limb muscle strengthening exercises and lumbar spine region on decreasing the intensity of chronic musculoskeletal pain in cadets from Naval School. Methods: A randomized controlled trial with blind evaluator and allocation of participants in three parallel groups will be performed. Participating in the study, 81 cadets of the Naval Academy of Rio de Janeiro, between 18 and 24 years of age with chronic musculoskeletal pain in the lower limbs or in the lumbar region and who have the rearfoot as footstrike pattern. Participants will be randomly assigned into the following groups: (1) footstrike pattern transition from rearfoot to midfoot / forefoot; (2) muscle strengthening of the lower limbs and lower back; and (3) usual treatment group. Primary treatment outcomes will be pain and specific disability measured twelve weeks after randomization. Secondary treatment outcomes will be pain and specific disability measured six and nine months after randomization. An intention-to-treat analysis will be performed using mixed linear models to compare outcomes between groups.

Conditions

Chronic Musculoskeletal Pain

Keywords

musculoskeletal pain; physiotherapy; military; running

Outcome Measures

Primary Outcomes (2)

• Pain intensity: Brazilian version of the Numerical Pain Scale

  Pain intensity will be measured using the Brazilian version of the Numerical Pain Scale,whose ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain" based on the last seven days.

  Three months after randomization

• Specific disability

  Specific disability through the Patient Specific Functional Scale. At this scale, the participant should report three activities whose achievements are being hampered by pain. Participant should note the difficulty on a scale of 0 to 10, where 0 means "unable to perform activity" and 10 means "able to perform the activity as you did before the injury."

  Three months after randomization

Secondary Outcomes (4)

• Weekly running mileage

  Three months after randomization

• Weekly running mileage

  Six months after randomization

• Pain intensity: Brazilian version of the Numerical Pain Scale

  Six months after randomisation

• Specific disability

  Six months after randomisation

Study Arms (3)

Usual Treatment Group

ACTIVE COMPARATOR

This group will perform standard physiotherapeutic treatment performed at the Naval School. This treatment consists of the application of conventional TENS whose parameters are: alternating current, rectangular pulse, pulse duration 100μs, frequency of 100Hz for 12000 seconds. Laser therapy with an energy of 5 J at each point, irradiation area of 1cm², irradiation time of 20 seconds, 30 repetitions and total time of 6000 seconds.

Other: Usual Treatment Group

Transition from the Rearfoot to the Forefoot and Midfoot

ACTIVE COMPARATOR

Participants in this group will perform a training aimed at the transition of foot strike pattern from the rearfoot to the forefoot and midfoot progressively. Initially a ten-minute race will be held at a comfortable warm-up speed. Then the participants in this group will run continuously at the usual treadmill speed for thirty minutes in a 12-week progressive training program. The participants will receive verbal command "Try to touch first with the middle region of the foot on the treadmill". In the last four sessions, feedback will be gradually removed. At the end of each session, participants will be asked a question about the naturalness of running the new foot touch pattern on the ground. A scale from 0 to 10 will be used, where 0 means "very difficult to perform" and 10 indicates "easy" pattern. The perception of pain will also be evaluated with the numerical scale of pain of 11 points (0 to 10), where 0 means "no pain" and 10 "the greatest pain possible".

Other: Transition from the Rearfoot to the Forefoot and Midfoot

Muscle Strengthening Group

ACTIVE COMPARATOR

The participants of this group will perform muscle strengthening exercises for trunk and lower limbs divided into four phases of three weeks each. The total period of the program strength will be 12 weeks. Elastos® elastic bands of weak, medium and strong intensity will be used to provide progression to the exercises. The exercises will be supervised and supervised by two physiotherapists. A Phase 1 will consist of four exercises; a phase 2, phase 3 and phase 4 will consist of five different exercises each one. In addition to the muscle strengthening le strengthening protocol, this group will have free access to the standard physiotherapeutic treatment performed at the Naval School during and after the study.

Other: Muscle Strengthening Group

Interventions

Transition from the Rearfoot to the Forefoot and Midfoot OTHER

Participants in this group will perform a training aimed at the transition of foot strike pattern from the rearfoot to the forefoot and midfoot progressively. Initially a ten-minute race will be held at a comfortable warm-up speed. Then the participants in this group will run continuously at the usual treadmill speed for thirty minutes in a 12-week progressive training program. Participants will run shod and barefoot alternately. Each week the barefoot running time increased to 30 minutes.

Transition from the Rearfoot to the Forefoot and Midfoot

Usual Treatment Group OTHER

This group will perform standard physiotherapeutic treatment performed at the Naval School. This treatment consists of the application of conventional TENS whose parameters are: alternating current, rectangular pulse, pulse duration 100μs, frequency of 100Hz for 12000 seconds. Laser therapy with an energy of 5 J at each point, irradiation area of 1cm², irradiation time of 20 seconds, 30 repetitions and total time of 6000 seconds.

Usual Treatment Group

Muscle Strengthening Group OTHER

The participants of this group will perform muscle strengthening exercises for trunk and lower limbs divided into four phases of three weeks each. The total period of the program strength will be 12 weeks. Elastos® elastic bands of weak, medium and strong intensity will be used to provide progression to the exercises. The exercises will be supervised and supervised by two physiotherapists. A Phase 1 will consist of four exercises; a phase 2, phase 3 and phase 4 will consist of five different exercises each one. In addition to the muscle strengthening le strengthening protocol, this group will have free access to the standard physiotherapeutic treatment performed at the Naval School during and after the study.

Muscle Strengthening Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic musculoskeletal pain in the lower limbs and / or non-specific chronic low back pain that is related to running ("persistent pain" will be considered "chronic" for more than three months). Information on pain will be based on a self-completion questionnaire;
• rearfoot as a foot strike pattern;
• present at least one run-related limitation on the Specific Functional Scale of the Patient (EFEP);
• practice running 2 to 5 times a week.

You may not qualify if:

• have undergone a surgical procedure in the lower limbs and / or the lower back in the last six months;
• have performed invasive procedures for pain relief in the last three months; do not present a history of acute trauma such as fractures in the last six months, infection, signs of radiculopathy, compression of the marrow or equine tail.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Naval School: collaborator

Study Sites (2)

UNISUAM

Rio de Janeiro, Rio de Janeiro, 21041-020, Brazil

Location

Centro Universitário Augusto Motta

Rio de Janeiro, 21.041-020, Brazil

Location

Related Publications (19)

• Almeida MO, Davis IS, Lopes AD. Biomechanical Differences of Foot-Strike Patterns During Running: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2015 Oct;45(10):738-55. doi: 10.2519/jospt.2015.6019. Epub 2015 Aug 24.

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• Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83.

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• de Almeida MO, Saragiotto BT, Yamato TP, Lopes AD. Is the rearfoot pattern the most frequently foot strike pattern among recreational shod distance runners? Phys Ther Sport. 2015 Feb;16(1):29-33. doi: 10.1016/j.ptsp.2014.02.005. Epub 2014 Feb 26.

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• Esculier JF, Bouyer LJ, Dubois B, Fremont P, Moore L, McFadyen B, Roy JS. Is combining gait retraining or an exercise programme with education better than education alone in treating runners with patellofemoral pain?A randomised clinical trial. Br J Sports Med. 2018 May;52(10):659-666. doi: 10.1136/bjsports-2016-096988. Epub 2017 May 5.

  PMID: 28476901 BACKGROUND

• Esculier JF, Silvini T, Bouyer LJ, Roy JS. Video-based assessment of foot strike pattern and step rate is valid and reliable in runners with patellofemoral pain. Phys Ther Sport. 2018 Jan;29:108-112. doi: 10.1016/j.ptsp.2016.11.003. Epub 2016 Nov 23.

  PMID: 28666810 BACKGROUND

• Hauret KG, Jones BH, Bullock SH, Canham-Chervak M, Canada S. Musculoskeletal injuries description of an under-recognized injury problem among military personnel. Am J Prev Med. 2010 Jan;38(1 Suppl):S61-70. doi: 10.1016/j.amepre.2009.10.021.

  PMID: 20117601 BACKGROUND

• Hespanhol Junior LC, Pena Costa LO, Lopes AD. Previous injuries and some training characteristics predict running-related injuries in recreational runners: a prospective cohort study. J Physiother. 2013 Dec;59(4):263-9. doi: 10.1016/S1836-9553(13)70203-0.

  PMID: 24287220 BACKGROUND

• Knapik JJ, Graham B, Cobbs J, Thompson D, Steelman R, Jones BH. A prospective investigation of injury incidence and injury risk factors among Army recruits in military police training. BMC Musculoskelet Disord. 2013 Jan 17;14:32. doi: 10.1186/1471-2474-14-32.

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• Louw M, Deary C. The biomechanical variables involved in the aetiology of iliotibial band syndrome in distance runners - A systematic review of the literature. Phys Ther Sport. 2014 Feb;15(1):64-75. doi: 10.1016/j.ptsp.2013.07.002. Epub 2013 Aug 16.

  PMID: 23954385 BACKGROUND

• Nunns M, House C, Fallowfield J, Allsopp A, Dixon S. Biomechanical characteristics of barefoot footstrike modalities. J Biomech. 2013 Oct 18;46(15):2603-10. doi: 10.1016/j.jbiomech.2013.08.009. Epub 2013 Aug 27.

  PMID: 24054331 BACKGROUND

• Nye NS, Pawlak MT, Webber BJ, Tchandja JN, Milner MR. Description and Rate of Musculoskeletal Injuries in Air Force Basic Military Trainees, 2012-2014. J Athl Train. 2016 Nov;51(11):858-865. doi: 10.4085/1062-6050-51.10.10.

  PMID: 28068163 BACKGROUND

• Roper JL, Harding EM, Doerfler D, Dexter JG, Kravitz L, Dufek JS, Mermier CM. The effects of gait retraining in runners with patellofemoral pain: A randomized trial. Clin Biomech (Bristol). 2016 Jun;35:14-22. doi: 10.1016/j.clinbiomech.2016.03.010. Epub 2016 Apr 7.

  PMID: 27111879 BACKGROUND

• Salsich GB, Graci V, Maxam DE. The effects of movement pattern modification on lower extremity kinematics and pain in women with patellofemoral pain. J Orthop Sports Phys Ther. 2012 Dec;42(12):1017-24. doi: 10.2519/jospt.2012.4231. Epub 2012 Sep 5.

  PMID: 22960572 BACKGROUND

• Santuz A, Ekizos A, Janshen L, Baltzopoulos V, Arampatzis A. The Influence of Footwear on the Modular Organization of Running. Front Physiol. 2017 Nov 22;8:958. doi: 10.3389/fphys.2017.00958. eCollection 2017.

  PMID: 29213246 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ney Meziat, PhD

  Centro Universitario Augusto Motta, UNISUAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The permanence of the new foot strike pattern will be investigated as mediator of the pain and disability outcomes in the presence of the forefoot / midfoot pattern. It will be assessed by a blind assessor through observation of the participants' running footage using their usual sneakers three months after randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: November 18, 2019
• Study Start: June 15, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

BR (2)