Chronic Musculoskeletal PainNCT04166136
Efficacy of the Transition of the Foot Strike Pattern on Pain and Disability in Cadets With Musculoskeletal Pain
A study testing Transition from the Rearfoot to the Forefoot and Midfoot, Usual Treatment Group and Muscle Strengthening Group in people with Chronic Musculoskeletal Pain, run by Centro Universitário Augusto Motta at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Transition from the Rearfoot to the Forefoot and Midfoot, Usual Treatment Group and Muscle Strengthening Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBrazil
- Study dates
- 15 Jun 2019to 30 Aug 2020
- 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 18 to 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
UNISUAM
Rio de Janeiro, Rio de Janeiro, 21041-020
Centro Universitário Augusto Motta
Rio de Janeiro, 21.041-020
About this study
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
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.
Read the detailed description
A total of 81 participants will be enrolled in the study, randomized and allocated to one of the following three groups 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 20 minutes. 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 10 minutes.
4.4.3 Transition from the Rearfoot to the Forefoot and Midfoot Group: 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. See below: Week 1: 1min of barefoot running + 29 min of shod running Week 2: 2min of barefoot running + 28 min of shod running Week 3: 3min of barefoot running + 27 min of shod running Week 4: 5min of barefoot running + 25 min of shod running Week 5: 1min of barefoot running + 3 min of shod running (repeat 7 times) + 2 finals minuntes shod running Week 6: 1min of barefoot running +3 min of shod running (repeat 10 times) Week 7: 1min of barefoot running +1 min of shod running (repeat 15 times) Week 8: 10 min continuous of barefoot running + 20 min continuous of shod running Week 9: 15 min continuous of barefoot running + 15 min continuous of shod running Week 10: 20 min continuous of barefoot running + 10 min continuous of shod running Week 11: 25 min continuous of barefoot running + 5 min continuous of shod running Week 12: 30 min continuous of barefoot running Participants will receive verbal command "Avoid touching first with heel on the treadmill" and "Try to touch first with the middle region of the foot on the treadmill". If necessary, the investigator will provide additional feedback with verbal details about the foot strike pattern. During the first eight sessions continuous feedback will be given. 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 / unnatural standard" and 10 indicates "easy / natural" 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". Weekly participants will receive visual feedback through slow-motion footage of their footfall during the race, along with investigator guidance on the new tread pattern. In addition to the treadmill transition 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: The participants of this group will perform muscle strengthening exercises for trunk and lower limbs divided into four phases of three weeks each, following the protocol adapted from Esculier et al. (Esculier et al., 2017) 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 by two investigators.
- A Phase 1 will consist of four exercises:
- Participant lying sideways, raise the upper leg while lightly pushing it back. Hold position. The exercise should be performed on both sides of the body 2 times a week. In the first week, 2 sets with 10 repetitions and permanence time of 5 seconds, with progression in the following weeks to 15 repetitions of 10 seconds. An elastic band will be worn around the legs at the ankles. II. Participant lying sideways, knees bent, raise the upper knee. The pelvis should remain stable, both feet together. The exercise should be performed on both sides of the body 2 times a week. In the first week, 2 sets with 10 repetitions and stay time of 5 seconds, with progression in the following weeks to 15 repetitions of 10 seconds. An elastic band will be worn around the legs at the knees. III. Participant lying on the back, knees bent, raise the pelvis and hold the bridge position. Extend one of the knees (one-sided bridge). The pelvis should remain elevated. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds IV. Participant looking at the mirror, step up the step slowly. Step down slowly with the same leg keeping the alignment of the knee and pelvis. The exercise should be performed with the 2 legs, 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions and the height of the step to 20 centimeters.
- Phase 2 will consist of five exercises:
- Participant stand, with elastic band around the knees, squat while keeping the knees in line with the feet (squatting). Do not allow the tip of the knees to move in front of the feet. The exercise should be performed twice a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds. VI. Participant looking at the mirror, step down slowly. Step up again with the same leg keeping the focus on aligning the knees. The exercise should be performed with both legs 2 times a week. In the first week, 3 sets with 10 repetitions in the step with 10 cm in height. with progression in the following weeks for 15 repetitions and the height of the step to 20 centimeters. VII. Participant with the elastic band around the ankles, push in 3 different directions using the hip musculature. The exercise should be performed with both legs, 2 times a week, 10 repetitions per direction and in 3 directions. The elastic tension is increased as needed. VIII. Participant holding the body up using elbows and forearms, raise the pelvis and keep the back straight (plank). Hold this position. The exercise should be performed twice a week. In the first week, 5 replicates with a 10 second residence time, with progression in the following weeks to 10 repetitions of 10 seconds. IX. Participant on the side, supporting the body using elbow and forearm, raise the pelvis and keep the back straight (lateral board). Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 replicates with a 10 second residence time, with progression in the following weeks to 10 repetitions of 10 seconds.
- Phase 3 will consist of five exercises:
- Participant standing on one leg, squat, hold the knee toward the foot (one-sided squat). Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds. XI. Participant looking at the mirror, on a step and with an elastic pulling the knee inward step down and step up slowly. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters. XII. Participant standing on one leg, perform the squat while rotating the trunk. Touch the outside of the foot using the opposite hand. Stay in that position. Return to the starting position by turning the hip. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 2 sets with 15 repetitions and 10 seconds of permanence. XIII. Participant holding the body up using elbows and forearms, elevate the pelvis. Remove one foot from the ground while remaining with the knee extended. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 repetitions with 10 second permanence time in each leg, with progression to 5 repetitions of 10 seconds in each leg. XIV. Participant on the side, supporting the body using elbow and forearm, raise the pelvis, keep the back straight (unilateral board) while raising the upper leg. Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 repetitions and 10 second permanence time with progression in the following weeks for 10 repetitions and 10 second permanence time.
- Phase 4 will consist of five exercises:
XV. Participant looking at the mirror, with an elastic pulling the knee inward perform a squat while maintaining the alignment of the knee. The other leg stays forward, with the foot off the ground. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds.
XVI. Participant looking at the mirror, on top of a step and with a stronger elastic than the one used in exercise XI pulling the knee inward, step down and step up slowly. The exercise should be performed with both legs 2 times a week. In the first week, 3 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters.
XVII. Participant standing on one leg and looking at the mirror, jump off the step with one leg and land smoothly in the squatting position. Be sure to keep good control of the knee and pelvis. An elastic strap pulling the support knee inward can be used to increase the difficulty. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters.
XVIII. Participant holding the body up using elbows and forearms resting on flexible balance discs, elevate the pelvis. Remove one foot from the ground while remaining with the knee extended. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 repetitions with 10 second permanence time in each leg, with progression to 5 repetitions of 10 seconds in each leg.
XIX. Participant on the side, supporting the body using elbow and forearm supported on a flexible balancing disc, raise the pelvis, keep the back straight (unilateral board) while raising the upper leg. Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 repetitions and 10 second permanence time with progression in the following weeks for 10 10 second repetitions.
In addition to the muscle strengthening protocol, this group will have free access to the standard physiotherapeutic treatment performed at the Naval School during and after the study.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Transition from the Rearfoot to the Forefoot and Midfoot, Usual Treatment Group, Muscle Strengthening Group
- Keywords
- musculoskeletal pain, physiotherapy, military, running
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition from the Rearfoot to the Forefoot and MidfootOther
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.
Usual Treatment GroupOther
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.
Muscle Strengthening GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: 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. Receives: Other: Muscle Strengthening Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: Three months after randomization
Secondary outcomes (4)
Weekly running mileage
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?".
Measured: Three months after randomization
Weekly running mileage
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?".
Measured: Six months after randomization
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.
Measured: Six months after randomisation
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."
Measured: Six months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Jun 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Why it stopped: Because of the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Collaborators
- Naval School
- Responsible party
- Sponsor
- Investigators
- Ney Meziat, PhD, Principal investigator, Centro Universitario Augusto Motta, UNISUAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166136
- Sponsor's protocol ID
- TFSP
- Status last verified
- Oct 2022
- First submitted
- 1 Jun 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26304644Barton CJ, Levinger P, Crossley KM, Webster KE, Menz HB. The relationship between rearfoot, tibial and hip kinematics in individuals with patellofemoral pain syndrome. Clin Biomech (Bristol). 2012 Aug;27(7):702-5. doi: 10.1016/j.clinbiomech.2012.02.007. Epub 2012 Mar 20.
PubMed 22436492Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
PubMed 19765240Bullock SH, Jones BH, Gilchrist J, Marshall SW. Prevention of physical training-related injuries recommendations for the military and other active populations based on expedited systematic reviews. Am J Prev Med. 2010 Jan;38(1 Suppl):S156-81. doi: 10.1016/j.amepre.2009.10.023.
PubMed 20117590Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
PubMed 18923324Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83.
PubMed 26330672de 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.
PubMed 24894762Diebal AR, Gregory R, Alitz C, Gerber JP. Forefoot running improves pain and disability associated with chronic exertional compartment syndrome. Am J Sports Med. 2012 May;40(5):1060-7. doi: 10.1177/0363546512439182. Epub 2012 Mar 16.
PubMed 22427621Esculier 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.
PubMed 28476901Esculier 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.
PubMed 28666810Hauret 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.
PubMed 20117601Hespanhol 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.
PubMed 24287220Knapik 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.
PubMed 23327563Louw 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.
PubMed 23954385Nunns 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.
PubMed 24054331
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04166136
- Acronym / sponsor ID
- TFSP
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- musculoskeletal pain, physiotherapy, military, running
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the pandemic
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Collaborators
- Naval School
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 18 Nov 2019 (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.
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.
Detailed description
A total of 81 participants will be enrolled in the study, randomized and allocated to one of the following three groups 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 20 minutes. 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 10 minutes.
4.4.3 Transition from the Rearfoot to the Forefoot and Midfoot Group: 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. See below: Week 1: 1min of barefoot running + 29 min of shod running Week 2: 2min of barefoot running + 28 min of shod running Week 3: 3min of barefoot running + 27 min of shod running Week 4: 5min of barefoot running + 25 min of shod running Week 5: 1min of barefoot running + 3 min of shod running (repeat 7 times) + 2 finals minuntes shod running Week 6: 1min of barefoot running +3 min of shod running (repeat 10 times) Week 7: 1min of barefoot running +1 min of shod running (repeat 15 times) Week 8: 10 min continuous of barefoot running + 20 min continuous of shod running Week 9: 15 min continuous of barefoot running + 15 min continuous of shod running Week 10: 20 min continuous of barefoot running + 10 min continuous of shod running Week 11: 25 min continuous of barefoot running + 5 min continuous of shod running Week 12: 30 min continuous of barefoot running Participants will receive verbal command "Avoid touching first with heel on the treadmill" and "Try to touch first with the middle region of the foot on the treadmill". If necessary, the investigator will provide additional feedback with verbal details about the foot strike pattern. During the first eight sessions continuous feedback will be given. 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 / unnatural standard" and 10 indicates "easy / natural" 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". Weekly participants will receive visual feedback through slow-motion footage of their footfall during the race, along with investigator guidance on the new tread pattern. In addition to the treadmill transition 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: The participants of this group will perform muscle strengthening exercises for trunk and lower limbs divided into four phases of three weeks each, following the protocol adapted from Esculier et al. (Esculier et al., 2017) 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 by two investigators.
- A Phase 1 will consist of four exercises:
- Participant lying sideways, raise the upper leg while lightly pushing it back. Hold position. The exercise should be performed on both sides of the body 2 times a week. In the first week, 2 sets with 10 repetitions and permanence time of 5 seconds, with progression in the following weeks to 15 repetitions of 10 seconds. An elastic band will be worn around the legs at the ankles. II. Participant lying sideways, knees bent, raise the upper knee. The pelvis should remain stable, both feet together. The exercise should be performed on both sides of the body 2 times a week. In the first week, 2 sets with 10 repetitions and stay time of 5 seconds, with progression in the following weeks to 15 repetitions of 10 seconds. An elastic band will be worn around the legs at the knees. III. Participant lying on the back, knees bent, raise the pelvis and hold the bridge position. Extend one of the knees (one-sided bridge). The pelvis should remain elevated. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds IV. Participant looking at the mirror, step up the step slowly. Step down slowly with the same leg keeping the alignment of the knee and pelvis. The exercise should be performed with the 2 legs, 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions and the height of the step to 20 centimeters.
- Phase 2 will consist of five exercises:
- Participant stand, with elastic band around the knees, squat while keeping the knees in line with the feet (squatting). Do not allow the tip of the knees to move in front of the feet. The exercise should be performed twice a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds. VI. Participant looking at the mirror, step down slowly. Step up again with the same leg keeping the focus on aligning the knees. The exercise should be performed with both legs 2 times a week. In the first week, 3 sets with 10 repetitions in the step with 10 cm in height. with progression in the following weeks for 15 repetitions and the height of the step to 20 centimeters. VII. Participant with the elastic band around the ankles, push in 3 different directions using the hip musculature. The exercise should be performed with both legs, 2 times a week, 10 repetitions per direction and in 3 directions. The elastic tension is increased as needed. VIII. Participant holding the body up using elbows and forearms, raise the pelvis and keep the back straight (plank). Hold this position. The exercise should be performed twice a week. In the first week, 5 replicates with a 10 second residence time, with progression in the following weeks to 10 repetitions of 10 seconds. IX. Participant on the side, supporting the body using elbow and forearm, raise the pelvis and keep the back straight (lateral board). Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 replicates with a 10 second residence time, with progression in the following weeks to 10 repetitions of 10 seconds.
- Phase 3 will consist of five exercises:
- Participant standing on one leg, squat, hold the knee toward the foot (one-sided squat). Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds. XI. Participant looking at the mirror, on a step and with an elastic pulling the knee inward step down and step up slowly. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters. XII. Participant standing on one leg, perform the squat while rotating the trunk. Touch the outside of the foot using the opposite hand. Stay in that position. Return to the starting position by turning the hip. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 2 sets with 15 repetitions and 10 seconds of permanence. XIII. Participant holding the body up using elbows and forearms, elevate the pelvis. Remove one foot from the ground while remaining with the knee extended. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 repetitions with 10 second permanence time in each leg, with progression to 5 repetitions of 10 seconds in each leg. XIV. Participant on the side, supporting the body using elbow and forearm, raise the pelvis, keep the back straight (unilateral board) while raising the upper leg. Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 repetitions and 10 second permanence time with progression in the following weeks for 10 repetitions and 10 second permanence time.
- Phase 4 will consist of five exercises:
XV. Participant looking at the mirror, with an elastic pulling the knee inward perform a squat while maintaining the alignment of the knee. The other leg stays forward, with the foot off the ground. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions and 5 seconds permanence time, with progression in the following weeks for 15 repetitions of 10 seconds.
XVI. Participant looking at the mirror, on top of a step and with a stronger elastic than the one used in exercise XI pulling the knee inward, step down and step up slowly. The exercise should be performed with both legs 2 times a week. In the first week, 3 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters.
XVII. Participant standing on one leg and looking at the mirror, jump off the step with one leg and land smoothly in the squatting position. Be sure to keep good control of the knee and pelvis. An elastic strap pulling the support knee inward can be used to increase the difficulty. The exercise should be performed with both legs 2 times a week. In the first week, 2 sets with 10 repetitions in the step with 10 cm in height, with progression in the following weeks for 15 repetitions in a step of 20 centimeters.
XVIII. Participant holding the body up using elbows and forearms resting on flexible balance discs, elevate the pelvis. Remove one foot from the ground while remaining with the knee extended. Hold this position. The exercise should be performed with both legs 2 times a week. In the first week, 2 repetitions with 10 second permanence time in each leg, with progression to 5 repetitions of 10 seconds in each leg.
XIX. Participant on the side, supporting the body using elbow and forearm supported on a flexible balancing disc, raise the pelvis, keep the back straight (unilateral board) while raising the upper leg. Hold this position. Exercise should be performed on both sides. The exercise should be performed twice a week. In the first week, 5 repetitions and 10 second permanence time with progression in the following weeks for 10 10 second repetitions.
In addition to the muscle strengthening protocol, this group will have free access to the standard physiotherapeutic treatment performed at the Naval School during and after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Treatment Group | Active comparator | Other: Usual Treatment GroupThis 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. |
| Transition from the Rearfoot to the Forefoot and Midfoot | Active comparator | Other: Transition from the Rearfoot to the Forefoot and MidfootParticipants 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". |
| Muscle Strengthening Group | Active comparator | Other: Muscle Strengthening GroupThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Transition from the Rearfoot to the Forefoot and MidfootParticipants 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. | Other | Transition from the Rearfoot to the Forefoot and Midfoot |
| Usual Treatment GroupThis 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 |
| Muscle Strengthening GroupThe 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 |
Primary outcome
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.
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."
4 secondary outcomes
Weekly running mileage
Time frame: Three months after randomization
Weekly running mileage
Time frame: Six months after randomization
Pain intensity: Brazilian version of the Numerical Pain Scale
Time frame: Six months after randomisation
Specific disability
Time frame: Six months after randomisation
Results and safety
The study was stopped early (reason given: Because of the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 26304644Almeida 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.
- Background: PubMed 22436492Barton CJ, Levinger P, Crossley KM, Webster KE, Menz HB. The relationship between rearfoot, tibial and hip kinematics in individuals with patellofemoral pain syndrome. Clin Biomech (Bristol). 2012 Aug;27(7):702-5. doi: 10.1016/j.clinbiomech.2012.02.007. Epub 2012 Mar 20.
- Background: PubMed 19765240Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
- Background: PubMed 20117590Bullock SH, Jones BH, Gilchrist J, Marshall SW. Prevention of physical training-related injuries recommendations for the military and other active populations based on expedited systematic reviews. Am J Prev Med. 2010 Jan;38(1 Suppl):S156-81. doi: 10.1016/j.amepre.2009.10.023.
- Background: PubMed 18923324Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
- Background: PubMed 26330672Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83.
- Background: PubMed 24894762de 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.
- Background: PubMed 22427621Diebal AR, Gregory R, Alitz C, Gerber JP. Forefoot running improves pain and disability associated with chronic exertional compartment syndrome. Am J Sports Med. 2012 May;40(5):1060-7. doi: 10.1177/0363546512439182. Epub 2012 Mar 16.
- Background: PubMed 28476901Esculier 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.
- Background: PubMed 28666810Esculier 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.
- Background: PubMed 20117601Hauret 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.
- Background: PubMed 24287220Hespanhol 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.
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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.
Ney Meziat, PhD principal investigator
Centro Universitario Augusto Motta, UNISUAM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition from the Rearfoot to the Forefoot and Midfoot, Usual Treatment Group and Muscle Strengthening Group in people with Chronic Musculoskeletal Pain, run by Centro Universitário Augusto Motta at 2 sites in Brazil.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 was stopped early (reason given: Because of the pandemic). Results are not available in the source record.
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?
Pain intensity: Brazilian version of the Numerical Pain Scale (time frame: Three months after randomization). The study lists 2 primary outcomes in all. 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 NCT04166136, which also lists 19 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 3 Nov 2022.