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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04166136
Other study ID # TFSP
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 15, 2019
Est. completion date August 30, 2020

Study information

Verified date October 2022
Source Centro Universitário Augusto Motta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


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Intervention

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Locations

Country Name City State
Brazil Centro Universitário Augusto Motta Rio de Janeiro
Brazil UNISUAM Rio de Janeiro RJ

Sponsors (2)

Lead Sponsor Collaborator
Centro Universitário Augusto Motta Naval School

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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?". Three months after randomization
Secondary 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?". Six months after randomization
Secondary 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. Six months after randomisation
Secondary 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." Six months after randomisation
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