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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Pain intensity: Brazilian version of the Numerical Pain Scale
研究概览
简要总结
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.
详细描述
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:
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 25 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain intensity: Brazilian version of the Numerical Pain Scale
时间窗: 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
时间窗: 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."
次要结局
- 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)
