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

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ClinicalTrials.gov Identifier: NCT04166136
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
Naval School
Information provided by (Responsible Party):
Centro Universitário Augusto Motta

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.

Condition or disease Intervention/treatment Phase
Chronic Musculoskeletal Pain Other: Transition from the Rearfoot to the Forefoot and Midfoot Other: Usual Treatment Group Other: Muscle Strengthening Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Efficacy of the Transition of the Foot Strike Pattern From Rearfoot to Midfoot or Forefoot During Running on Pain and Disability in Cadets With Chronic Musculoskeletal Pain
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Usual Treatment Group
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
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.

Active Comparator: Transition from the Rearfoot to the Forefoot and Midfoot
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
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.

Active Comparator: Muscle Strengthening Group
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
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.




Primary Outcome Measures :
  1. Pain intensity: Brazilian version of the Numerical Pain Scale [ Time Frame: Three months after randomization ]
    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.

  2. Specific disability [ Time Frame: Three months after randomization ]
    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."


Secondary Outcome Measures :
  1. Weekly running mileage [ Time Frame: Three months after randomization ]
    Weekly running mileage will be obtained through a self-completion questionnaire in which participants will answer the following question: "How many kilometers do you run per week?".

  2. Weekly running mileage [ Time Frame: Six months after randomization ]
    Weekly running mileage will be obtained through a self-completion questionnaire in which participants will answer the following question: "How many kilometers do you run per week?".

  3. Pain intensity: Brazilian version of the Numerical Pain Scale [ Time Frame: Six months after randomisation ]
    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.

  4. Specific disability [ Time Frame: Six months after randomisation ]
    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."



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. rearfoot as a foot strike pattern;
  3. present at least one run-related limitation on the Specific Functional Scale of the Patient (EFEP);
  4. practice running 2 to 5 times a week.

Exclusion Criteria:

  1. have undergone a surgical procedure in the lower limbs and / or the lower back in the last six months;
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166136


Contacts
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Contact: Thaís FB Pinheiro, Master's student 55 21 998060266 thaisfborba@gmail.com
Contact: Ney Meziat-Filho, PhD 55 21 998051366 thaisfborba@gmail.com

Locations
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Brazil
UNISUAM Not yet recruiting
Rio de Janeiro, RJ, Brazil, 21041-020
Contact: Ney Meziat-Filho, PhD    +55 21 998051386    neymeziat@gmail.com   
Contact: Thais TB Pinheiro    +55 21 998060266    thaisfborba@gmail.com   
Centro Universitário Augusto Motta Recruiting
Rio de Janeiro, Brazil, 21.041-020
Contact: Ney Meziat-Filho, PhD    55 21 38829797 ext 2012    neymeziat@gmail.com   
Contact: Arthur S Ferreira, PhD    55 21 999151800    arthurde@unisuamdoc.com.br   
Principal Investigator: Ney Meziat-FIlho, PhD         
Sponsors and Collaborators
Centro Universitário Augusto Motta
Naval School
Investigators
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Principal Investigator: Ney Meziat, PhD Centro Universitario Augusto Motta, UNISUAM
  Study Documents (Full-Text)

Documents provided by Centro Universitário Augusto Motta:
Statistical Analysis Plan  [PDF] November 6, 2019
Informed Consent Form  [PDF] November 6, 2019

Publications:

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Responsible Party: Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT04166136    
Other Study ID Numbers: TFSP
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro Universitário Augusto Motta:
musculoskeletal pain
physiotherapy
military
running
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations