- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627581
Foam Roller Versus Self-Performed Neurodynamic Sliding in People With Hamstring Tightness and Low Back Pain History
Effects of Self-Myofascial Release With Foam Roller Versus Self-Performed Neurodynamic Sliding on Hamstring Flexibility in People With Hamstring Tightness and a History of Low Back Pain: A Randomized Pilot Clinical Trial
This randomized crossover pilot clinical trial evaluated the effects of two self-administered physiotherapy techniques in people with hamstring tightness and a history of non-specific low back pain.
Participants were randomly assigned to one of two treatment sequences. One sequence performed self-myofascial release using a foam roller first, followed by a one-month washout period, and then performed a self-administered neurodynamic sliding technique. The other sequence performed the neurodynamic sliding technique first, followed by a one-month washout period, and then performed the foam roller intervention.
The main objective of the study was to compare the effects of both interventions on hamstring flexibility. Secondary outcomes included active knee extension range of motion, dynamic balance, pressure pain threshold, hamstring and gluteus maximus strength, and low back pain intensity.
연구 개요
상태
정황
상세 설명
Low back pain is a common musculoskeletal condition, and hamstring tightness has been proposed as a potential contributing factor due to its influence on pelvic and lumbar biomechanics. Different physiotherapy interventions may be used to improve hamstring flexibility, including self-myofascial release with a foam roller and neurodynamic sliding techniques.
This study was designed as a randomized, crossover, pilot clinical trial with two active interventions. Participants were people with hamstring tightness and a history of recurrent or chronic non-specific low back pain. Eligible participants were randomly assigned to one of two intervention sequences.
In one sequence, participants first performed self-myofascial release using a foam roller on the hamstring muscles. After a one-month washout period, they then performed the self-administered neurodynamic sliding technique. In the other sequence, participants first performed the self-administered neurodynamic sliding technique. After a one-month washout period, they then performed the self-myofascial release intervention using a foam roller.
The foam roller intervention consisted of bilateral self-myofascial release of the hamstring muscles for 2 minutes per leg over three consecutive days. The neurodynamic sliding intervention consisted of a seated self-administered neurodynamic sliding technique over three consecutive days, with 3 sets of 20 repetitions and 20 seconds of rest between sets.
Assessments were performed before and after each intervention period. The primary outcome was hamstring flexibility measured using the Straight Leg Raising test. Secondary outcomes included hamstring flexibility measured using the Active Knee Extension test, dynamic balance assessed with the Y-Balance Test, pressure pain threshold over myofascial trigger points, isometric strength of the hamstrings and gluteus maximus, and low back pain intensity measured with the Numeric Pain Rating Scale.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sara Perpiña Martinez, PT, PhD
- 전화번호: 1032 (+34) 910053661
- 이메일: sperpinama@upsa.es
연구 장소
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Madrid
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Madrid, Madrid, 스페인, 28015
- Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
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연락하다:
- Sara Perpiña Martinez, PT, PhD
- 전화번호: 1032 (+34) 910053661
- 이메일: sperpinama@upsa.es
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Men and women aged 16 years or older.
- History of non-specific low back pain during the previous three months and/or recurrent or chronic non-specific low back pain.
- Limited hamstring flexibility, defined as hamstring tightness with 75 degrees or less of hip flexion with knee extension during the Straight Leg Raise test.
- No previous surgery involving the spine or lower limb.
- No hamstring stretching exercises performed in the weeks prior to participation.
- Ability and willingness to provide informed consent.
- Availability to perform both self-administered physiotherapy techniques according to the study protocol.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- History of hamstring muscle or tendon injury during the previous year.
- Lumbar or lower-limb neurological deficits.
- Lower-limb length discrepancy.
- Specific spinal pathology, including tumor, infection, fracture, or inflammatory disease.
- History of lumbar disc herniation.
- History of whiplash injury.
- Any contraindication to physical exercise.
- Menstrual pain at the time of assessment or intervention.
- Scheduled surgery during the intervention or follow-up period.
- History of cardiac disease.
- Incomplete or incorrectly completed questionnaires or missing assessment data.
- Refusal to complete part or all of the study intervention.
- Development of a low back pain episode during the study intervention.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Foam Roller First, Then Neurodynamic Sliding
Participants assigned to this sequence will first perform self-myofascial release using a foam roller on the hamstring muscles.
After a one-month washout period, they will perform the self-administered neurodynamic sliding technique.
|
Participants will perform bilateral self-myofascial release of the hamstring muscles using a foam roller.
The technique will be performed for 2 minutes per leg over three consecutive days.
Participants will perform a seated self-administered neurodynamic sliding technique over three consecutive days.
The intervention will consist of 3 sets of 20 repetitions, with 20 seconds of rest between sets.
|
|
실험적: Neurodynamic Sliding First, Then Foam Roller
Participants assigned to this sequence will first perform the self-administered neurodynamic sliding technique.
After a one-month washout period, they will perform self-myofascial release using a foam roller on the hamstring muscles.
|
Participants will perform bilateral self-myofascial release of the hamstring muscles using a foam roller.
The technique will be performed for 2 minutes per leg over three consecutive days.
Participants will perform a seated self-administered neurodynamic sliding technique over three consecutive days.
The intervention will consist of 3 sets of 20 repetitions, with 20 seconds of rest between sets.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hamstring Flexibility Measured With the Straight Leg Raise Test
기간: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Hamstring flexibility will be assessed using the Straight Leg Raise test.
The test will be performed with the participant in the supine position, and hip flexion range of motion will be measured in degrees using a goniometer.
Higher values indicate greater hamstring flexibility.
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Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Hamstring Flexibility Measured With the Active Knee Extension Test
기간: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Hamstring flexibility will be assessed using the Active Knee Extension test.
The knee extension angle will be measured in degrees using a goniometer, with the hip positioned at 90 degrees of flexion.
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Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Change in Dynamic Balance Measured With the Y-Balance Test
기간: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Dynamic balance will be assessed using the Y-Balance Test.
Reach distances in the anterior, posteromedial, and posterolateral directions will be recorded in centimeters and normalized to lower limb length.
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Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Change in Pressure Pain Threshold
기간: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Isometric strength of the hamstring muscles and gluteus maximus will be assessed using a handheld dynamometer.
Values will be recorded in Newtons, with higher values indicating greater muscle strength.
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Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Change in Low Back Pain Intensity
기간: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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Low back pain intensity will be assessed using the Numeric Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sara Perpiña Martínez, PT, PhD, Pontifical University of Salamanca
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UPSA_HAM_LBP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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