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Corticospinal Excitability of Deep Back and Abdominal Muscles

2020년 2월 18일 업데이트: Peemongkon Wattananon, Mahidol University

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

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.

연구 개요

상세 설명

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.

The subjects in both groups will perform hamstrings muscle stretching in standing position. The participants will be asked to place the heel on the tested leg on the compression load cell mounted on the adjustable treatment table. The adjustable treatment table will be initially set at the subject's knee level. Treatment table will gradually move up until force at the heel reaches 15% of the body weight. This standardized force will be controlled by the compression load cell. Our preliminary study indicates that 15% of the body weight is the maximal stretching force in which subjects have reported very hard level of exertion (16-18 out of 20) on RPE during stretching exercise. During applying stretching force, subjects in LPS will be asked to keep the lumbar and pelvic positions as rigid as possible without holding the breath, while subjects in LPR will be asked to relax the lumbopelvic region and do not hold against stretching force. Each subject will perform 4 repetitions of 30-second stretching with 15 seconds rest between repetitions.

After the intervention, the subjects will be reassessed for lumbopelvic motion during forward bend and hamstrings muscle length test. The intervention and reassessment process will take approximately 20 minutes. The data at baseline and post-intervention will be used to determine the effect of lumbopelvic stabilization during hamstring muscle stretching in individuals with and without a history of CLI. In addition, the investigator will call each subject for 1-year follow up to check whether subjects have any episode of low back pain and how often the participants have low back pain.

연구 유형

중재적

등록 (실제)

24

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Nakhon Pathom
      • Salaya, Nakhon Pathom, 태국, 73170
        • Faculty of Physical Therapy, Mahidol University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • The inclusion criteria for individuals without a history of clinical lumbar instability.

    1. Between the ages of 20 and 40
    2. 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.

    1. Between the ages of 20 and 40
    2. A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
    3. Presenting aberrant movement pattern during active forward bend test
    4. Passive straight leg raising test (SLR) greater than 91 degrees
    5. Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 요골반 강화 기술
요골반 강화 기법을 이용한 햄스트링 근육 스트레칭.
Participants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
활성 비교기: 요골반 이완 기법
요골반 이완 기법으로 햄스트링 근육 스트레칭.
Participants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Resting and active motor threshold
기간: 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.
These data will be collected at baseline only.
Motor evoke potentials
기간: These data will be collected at baseline only.
Motor evoke potentials (MEP) for transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Center of gravity of Topography
기간: These data will be collected at baseline only.
Center of gravity coordinate of Topography of transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Volume of Topography
기간: These data will be collected at baseline only.
Volume of Topography of transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Clinical observation of aberrant movement.
기간: These data will be collected at baseline only.
Clinical observation of aberrant movement patterns during functional movement will be performed by two physical therapists.
These data will be collected at baseline only.
Motion data.
기간: 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.
These data will be measure at baseline and immediately after receiving stretching exercise technique.

2차 결과 측정

결과 측정
측정값 설명
기간
Passive straight leg raising to test clinical lumbar instability
기간: These data will be collected at baseline only.
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
These data will be collected at baseline only.
Muscle length based on modified Thomas and Trendelenburg test
기간: These data will be collected at baseline only.
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
These data will be collected at baseline only.
Abdominal and back muscle strength .
기간: These data will be collected at baseline only.
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
These data will be collected at baseline only.
1-year follow-up.
기간: 1 year after data collection.
Participants will be call to check whether they have any episode of low back pain and how often they have low back pain.
1 year after data collection.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Peemongkon Wattananon, PhD, Faculty of Physical Therapy, Mahidol University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 12월 14일

기본 완료 (실제)

2020년 1월 6일

연구 완료 (실제)

2020년 1월 6일

연구 등록 날짜

최초 제출

2018년 11월 13일

QC 기준을 충족하는 최초 제출

2018년 11월 16일

처음 게시됨 (실제)

2018년 11월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 2월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 2월 18일

마지막으로 확인됨

2020년 2월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

The IPD of this study will be shared upon official request.

IPD 공유 기간

The supporting information will be sent upon official request.

IPD 공유 액세스 기준

Having an official written request.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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