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临床试验/NCT05479500
NCT05479500Unknown不适用

Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis Pain, Lower Extremity Functional Capacity and Quality of Life - Randomized Controlled Study

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
36
试验地点
2
主要终点
Ultrasonography

研究概览

简要总结

The primary aim of the study is to investigate the effectiveness of Myofascial Chain Release Techniques on pain, functional limitation and quality of life in patients with Plantar Fasciitis. The secondary aim of the study is to create a future clinical projection regarding the applications to be made over the myofascial chain in addition to the generally accepted treatment protocols in the light of the findings.

There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. Postural problems that can be seen in the superficial back myofascial chain line will be evaluated.

详细描述

The plantar fascia is an important connective structure that extends from the metatarsal heads to the calcaneus and provides the continuity of the longitudinal arch of the foot. Microtraumas and the formation of chronic inflammation on the plantar surface, which is exposed to repetitive stress, thickens the fascia, making it susceptible to repetitive injuries and forming plantar fasciitis. The reasons for this repetitive stress are; excessive physical activity, obesity, age, prolonged standing, biomechanical changes, limited dorsiflexion and hamstring tension.

Studies on this subject in the literature have reported that tension in the hind leg muscles is associated with plantar fasciitis, and applications on the Achilles tendon and gastrocnemius have been shown to relieve plantar fasciitis complaints. Similarly, it has been reported that tension in the hamstring muscle may be associated with the development of plantar fasciitis.

It is known that the Plantar Fascia and Achilles tendon affect each other due to the fascial connection, and therefore these structures are considered together in the solution of their problems. On the other hand, according to the fascial meridian concept developed by Thomas Myers, it was stated that the fascial connection between these two tissues extends to the frontal region in a chain manner, and that a problem at any point in the chain may cause problems in other elements of the chain. For this reason, recently, applications related to the detection and solution of problems have come to the fore by looking at fascial problems more holistically over the fascial chain. From this point of view, there are many studies reporting the effectiveness of applications performed in any region of the myofascial chain in a different region on this chain.

Plantar Fascia; It is located in the Superficial Back Line, and as far as we know, there is no study of plantar fasciitis treatment in which the myofascial chain is considered as a whole. Based on this, our aim in this study is to investigate the effect of myofascial release techniques applied along the myofascial chain line on pain, lower extremity functionality and quality of life in patients diagnosed with Plantar fasciitis. In the light of the findings, it is to create a projection for future clinical studies regarding the treatment approaches to be applied over the myofascial chain in addition to the generally accepted treatment protocols.

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

Participants will be divided into three groups using block randomization method. Participants will be randomly allocated into 3 blocks of 12 participants in each group using a random number generation technique by computer. All assessments will be done by researcher who were not in the study.

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers between the ages of 30-60
  • Diagnosed with plantar fasciitis
  • Not having received medical treatment and/or physiotherapy for plantar fasciitis in the last 3 months.
  • The participants' definition of pain over 3 according to the Visual Analogue Scale in the first step of the morning and this pain decreases with movements

排除标准

  • Having history of lower extremity surgery and fracture in the last 6 months
  • Having additional orthopedic, neurological and rheumatological diseases that may cause biomechanical malalignment, loss of muscle strength, and deterioration of gait parameters in the lower extremities, vertebral column and pelvis
  • Having static foot deformity
  • Having connective tissue disease that will affect tissue properties
  • Having metabolic syndromes that may affect tissue properties such as diabetes
  • Using sedatives and/or muscle relaxants that may alter muscle tone.
  • Being diagnosed with obesity (BMI>30)
  • Pregnancy

结局指标

主要结局

Ultrasonography

时间窗: Change from baseline ultrasonography at week 6.

It will be used to measure the thickness of the plantar fascia. As a result of these studies, a plantar fascia greater than 4 mm appears to be abnormal and associated with plantar fasciitis. Ultrasonography (USG) evaluation is a routine method for the diagnosis of Plantar Fasciitis.

Plantar Fasciitis Pain

时间窗: Change from baseline plantar fasciitis pain at week 6.

Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).

Pes planus

时间窗: Change from baseline pes planus at week 6.

Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.

Ankle Joint Angle

时间窗: Change from baseline ankle joint angles at week 6.

Active and passive dorsi and plantar flexion angles will be measured with a goniometer.

Hamstring Muscle shortness

时间窗: Change from baseline Hamstring muscle shortness at week 6.

Hamstring length will be measured with the straight leg lift test. The patient is asked to keep the opposite leg fixed on the bed with the knee straight in the supine position, wearing suitable clothes, and to raise the leg to be tested upwards with the ankle in dorsiflexion and the knee straight. The patient is instructed to wait where the initial tension occurs, and the last degree of movement is measured.

Passive Tone

时间窗: Change from baseline passive tone of myofascial tissues at week 6.

Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Headache

时间窗: Change from baseline Headache at week 6.

Presence of headache will be questioned and severity assessment will be made with Visual Analogue Scale. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).

Windlass Test

时间窗: Change from baseline Windlass Test at week 6.

While the patient is sitting in a chair, the big toe of the foot to be tested is brought into the dorsal flexion of the metatarsal phalangeal joint for a hard time. Pain at the junction of the plantar fascia with the calcaneus during this movement indicates a positive test.

Lower extremity functionality

时间窗: Change from baseline lower extremity functionality at week 6.

Lower extremity functional scale will be used. This scale is a valid and reliable scale used in musculoskeletal problems affecting the lower extremities. It consists of 20 items. Each item is scored between 0-4. The total score is between 0-80. Higher scores indicate better functional status.

Foot Posture

时间窗: Change from baseline foot posture at week 6.

Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.

Decrement

时间窗: Change from baseline Decrement of myofascial tissues at week 6.

Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Relaxation time

时间窗: Change from baseline Relaxation time of myofascial tissues at week 6.

Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Stiffness

时间窗: Change from baseline Stiffness of myofascial tissues at week 6.

Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Creep

时间窗: Change from baseline Creep of myofascial tissues at week 6.

Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Pelvic tilt

时间窗: Change from baseline pelvic tilt at week 6.

The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the spina iliaca anterior superior (SIAS) and spina iliaca posterior superior (SIPS) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.

Skin temperature of the Plantar Fascitis area

时间窗: Change from baseline Skin temperature of the Plantar Fascitis area at week 6.

In order to see the effectiveness of the applications, the skin temperature will be determined by thermal imaging method. This method is frequently preferred because it is a reliable and non-invasive method. The skin temperature of the plantar fascia will be measured with the P45 thermographic camera (Flir System, ThermaCAM, Sweden) with high thermal sensitivity, while the patient is in the prone position, while the feet are hanging from the bed at the level of the malleolus. The measurement will be made by placing the camera on a tripod placed 1m away from the patient. In the analysis, the area covering 1 cm distance from the point where fasciitis develops will be used. Skin temperature will be determined using the FLIR Quick-Report 1.2 software, one of the temperature indicators obtained from this region. In the calculation of skin temperature, the human skin emissivity value will be accepted as 0.98.

Algometer

时间窗: Change from baseline pressure pain threshold at week 6.

It is used to measure the pressure pain threshold. After localization of the painful area by palpation, force is applied with an algometer until patients feel pain and discomfort. The digit displayed on the algometer is recorded. The average of 3 measurements is taken.

Cervical and Lumbar Lordosis

时间窗: Change from baseline Cervical and Lumbar Lordosis at week 6.

It will be determined by photographing. Side photos will be taken while the patient is standing in a free standing position in front of a bare, flat wall with the upper body. Later, the obtained photo shoots will be analyzed with the Tracker 4.11.0 (Physlets, 2017) program and cervical and lumbar lordosis angles will be determined.

SF-12 Quality of Life

时间窗: Change from baseline Quality of Life at week 6.

An abbreviated form for assessing quality of life. SF-12, a form developed in 1994, is not specific to any age and disease type, and is a scale that evaluates the quality of life of the person during the last four weeks. SF-12; physical functionality includes physical role, pain, general health, emotional role, mental health, social functionality and vitality.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayca Evkaya Acar

Lecturer

Istanbul Medeniyet University

研究点 (2)

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