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临床试验/NCT03747185
NCT03747185已完成不适用

Corticospinal Excitability of Deep Back and Abdominal Muscles in Individuals With History of Clinical Lumbar Instability

Mahidol University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Center of gravity of Topography

研究概览

简要总结

This study aims to understand the roles of corticospinal excitability in controlling the trunk movement, and the clinical utility of clinical observation, as well as the effect of lumbopelvic stabilization during hamstrings muscle stretching.

详细描述

This study will use a sample of convenience between the ages of 20 and 40. Subjects with and without history of low back pain will be recruited by flyers posted in university physical therapy clinics in 2 locations, as well as word of mouth from subjects and friends. Subjects who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If the participants meet all inclusion criteria, the consent process will be performed. To ensure the participants understand the study, the participants will be simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form. Total data collection including intervention between pre- and post-intervention will take approximately 2 hours.

After obtaining the written informed consent, all participants will fill out the information sheet for demographic data. Participant will have the right to refuse answering the demographic questionnaire, but the participants can participate in biomechanical data collection. Then, participants will asked to remove the metal accessories that could influence the electromagnetic field, change the cloth to lab tank top and shorts to expose the lower back and right knee, and wear the shoes throughout the test protocol. The body landmarks will be identified. These landmarks include 1) lumbar spine level 1 (L1), 2) sacrum level 2 (S2), 3) lateral epicondyle of right (RE) and left (LE) knees, and 4) head of fibula of right (RF) and left (LF) leg. These locations will be used to place motion sensors for outcome measures. The preparation process will take approximately 10 minutes.

The subjects will stand in a natural stance with arms down by sides. The participants will be instructed to perform functional movements including active forward bend, right and left straight leg raise tests, right and left hip abduction with knee flexion tests, quadruped backward rock test, prone with right and left knee flexion tests, prone with right and left hip internal/external rotation tests, prone with right and left hip extension tests. Each subject performs 2 trials of 3 consecutive repetitions of each functional movement tests. Heart rate and rating of perceive exertion (RPE) will be monitored after each functional movement tests. Two physical therapists (PT-A and PT-B), who are blinded to the group membership, will simultaneously observe and independently rate aberrant movement patterns. After physical therapists completing the clinical observation, the participants will hand the rating form to the principal investigator to input into a spreadsheet for further analysis. These data will be used to determine inter-rater reliability and diagnostic accuracy of clinical observation of aberrant movement patterns during functional movements to identify individuals with a history of CLI. The clinical observation will take about 20 minutes.

Prior to performing SLR, motion sensors will be placed on the subject's body landmarks. Subjects will be asked to perform one repetition of active forward bend, while motion data are simultaneously collected. Then, subjects will be asked to lay on the treatment table in supine position. PT-A will perform passive SLR, and maximal angle will be recorded. This SLR test is intended to determine whether the subject has a sign of CLI, rather than to assess neural tension (to rule out HNP and dural tension) or hamstrings muscle length. In participants with clinical lumbar instability, pelvis/hip will not be stabilized when performing passive SLR. In this case, when pelvis/hip has reached its restriction by hamstrings muscle tightness, lumbar spine would easily allow compensatory motion. Thus, leg raising greater than 91° would indicate clinical lumbar instability. This test is differed from hamstrings muscle tightness (passive knee extension in supine with 90° hip flexion position). This test the clinician will fix the pelvic/hip at 90°; therefore, compensatory motion from pelvis/hip will be minimized. After that, PT-A will perform hamstrings muscle length test. Subjects will be first asked to lay on the treatment table with tested hip and knee in 90 degrees flexion. PT-A will passively extend subject's knee to maximal tolerable point. Angle in sagittal plane between lateral epicondyle and head of fibula sensors will be measured to represent hamstrings muscle length. PT-A will perform additional clinical examination including modified Thomas test (muscle length test for iliopsoas, quadriceps, hip abductor, and hip adductor muscles), Ober's test (muscle length test for tensor fascia latae muscle), as well as abdominal and back muscle strength test assessed by a handheld dynamometer. These outcome measures will be assessed for baseline. To reduce the risk of muscle fatigue, the investigators will monitor heart rate and verbally ask the RPE during the test, and provide adequate resting period between repetitions. The clinical examination will take approximately 10 minutes.

After clinical data collection, the subjects will undergo corticospinal excitability measurement using transcranial magnetic stimulation (TMS). The investigator will identify transversus abdominis muscle (2 cm medial and 2 cm inferior to anterior superior iliac spine on the inguinal line), and lumbar multifidus muscle (2 cm lateral to lumbar spinous process of level 4). These locations will be used for EMG electrode placement. Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned parallel to the muscle fibers. Then, Subjects will be seated comfortably in a reclined chair with both arms supported. The participants will be asked to wear a swim cap used to identify stimulation areas for transverse abdominis and lumbar multifidus muscles. The investigator will use a double cone coil to find the hotspot for both ipsilateral and contralateral to the pain in each muscle. Figure 1 illustrates TMS set up. After corticospinal excitability measurement, subjects will be randomly assigned into 2 groups (lumbopelvic stabilization, LPS and lumbopelvic relaxation, LPR). The TMS data collection will take approximately 60 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The assessor and investigator will be blinded to the random order. This process will be handled by the research manager.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria for individuals without a history of clinical lumbar instability.
  • Between the ages of 20 and 40
  • No history of LBP that interferes with activities of daily living and/or required treatment
  • The inclusion criteria for individuals with a history of clinical lumbar instability.
  • Between the ages of 20 and 40
  • A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
  • Presenting aberrant movement pattern during active forward bend test
  • Passive straight leg raising test (SLR) greater than 91 degrees
  • Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)

排除标准

  • History of seizure for either the subject or any family member
  • Implanted pacemaker
  • Clinical signs of systemic disease
  • Definitive neurologic signs including pain, weakness or numbness in the lower extremity
  • Previous spinal surgery
  • Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
  • Any lower extremity condition that would potentially alter trunk movement
  • Vestibular dysfunction
  • Extreme psychosocial involvement
  • Body mass index (BMI) greater than 30 kg/m2
  • Active treatment of another medical illness that would preclude participation in any aspect of the study
  • Menstruation or pregnancy (for female subject)
  • Diagnosed herniated nucleus pulposus (HNP)
  • Pain medication usage (e.g., NSAID)

结局指标

主要结局

Center of gravity of Topography

时间窗: These data will be collected at baseline only.

Center of gravity coordinate of Topography of transverse abdominis and lumbar multifidus muscles.

Motor evoke potentials

时间窗: These data will be collected at baseline only.

Motor evoke potentials (MEP) for transverse abdominis and lumbar multifidus muscles.

Motion data.

时间窗: These data will be measure at baseline and immediately after receiving stretching exercise technique.

Clinical motion analysis system will be used to measure lumbar, pelvic, lumbopelvic, and knee motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.

Volume of Topography

时间窗: These data will be collected at baseline only.

Volume of Topography of transverse abdominis and lumbar multifidus muscles.

Clinical observation of aberrant movement.

时间窗: These data will be collected at baseline only.

Clinical observation of aberrant movement patterns during functional movement will be performed by two physical therapists.

Resting and active motor threshold

时间窗: These data will be collected at baseline only.

Resting and active motor threshold (MT) for ipsilateral and contralateral responses for transverse abdominis and lumbar multifidus muscles.

次要结局

  • Passive straight leg raising to test clinical lumbar instability(These data will be collected at baseline only.)
  • 1-year follow-up.(1 year after data collection.)
  • Muscle length based on modified Thomas and Trendelenburg test(These data will be collected at baseline only.)
  • Abdominal and back muscle strength .(These data will be collected at baseline only.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peemongkon Wattananon

Principal investigator

Mahidol University

研究点 (2)

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