- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07719699
Effects of Whole-Body Vibration and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain
Effects of Whole-Body Vibraton and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain
Chronic non-specific low back pain (CNSLBP) affects pain, balance, and functional ability. This randomized clinical trial aims to compare the effects of whole-body vibration (WBV) and Pilates, both combined with conventional physiotherapy, on pain, dynamic balance, and functional performance.
A total of 68 participants aged 18-40 years will be randomly assigned to either a WBV group or a Pilates group. Both groups will receive treatment three times per week for four weeks. Outcomes will be measured using the Visual Analog Scale (pain), Y-Balance Test (dynamic balance), and Progressive Isoinertial Lifting Evaluation (functional performance).
The results will help determine which intervention is more effective for managing CNSLBP and guide evidence-based rehabilitation practices.
연구 개요
상세 설명
Chronic non-specific low back pain (CNSLBP) is a highly prevalent musculoskeletal condition that significantly impairs pain levels, dynamic balance, and functional performance, leading to reduced mobility and quality of life. Although various rehabilitation strategies exist, uncertainty remains regarding the comparative effectiveness of different interventions, particularly between active exercise-based approaches and passive modalities.
Pilates is a widely used exercise therapy focusing on core stability, postural control, flexibility, and muscle coordination, and has demonstrated effectiveness in reducing pain and disability in individuals with CNSLBP. Whole-body vibration (WBV), on the other hand, is an emerging rehabilitation modality that utilizes mechanical vibrations to stimulate neuromuscular activation, potentially improving muscle strength, balance, and functional performance. However, most previous studies have combined WBV with exercise, making it difficult to isolate its independent effects.
This randomized clinical trial aims to directly compare the effects of whole-body vibration therapy and Pilates, both combined with conventional physiotherapy, on pain intensity, dynamic balance, and functional performance in patients with chronic non-specific low back pain.
A total of 68 participants aged 18-40 years with CNSLBP will be randomly allocated into two groups. Group A will receive whole-body vibration therapy along with conventional treatment, while Group B will receive Pilates exercises along with conventional treatment. Both interventions will be administered three times per week for four weeks.
Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), dynamic balance assessed using the Y-Balance Test, and functional performance assessed using the Progressive Isoinertial Lifting Evaluation (PILE) test. Assessments will be conducted by a blinded outcome assessor to minimize bias.
The findings of this study will provide high-quality evidence regarding the comparative effectiveness of WBV and Pilates, particularly in relation to dynamic balance, an underexplored but clinically important outcome. This study will help inform evidence-based rehabilitation strategies and guide clinicians in selecting appropriate interventions for individuals with CNSLBP, especially for patients who may have limited tolerance for conventional exercise programs.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr Mehwish Khalid, MSPT
- 전화번호: 03324302282
- 이메일: mehwish.khalid@ubas.edu.pk
연구 연락처 백업
- 이름: Sameera Nadeem, DPT
- 전화번호: 03084899169
- 이메일: sameeranadeem7894@gmail.com
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 53400
- 모병
- Surraya Azeem waqf hospital
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연락하다:
- Sajjad Ali Sajjad, Masters
- 전화번호: 03347329370
- 이메일: Sajjad.ali@umt.edu.pk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male and Female (18-40 years age)
- Pain lasting for more than 12 weeks(determined by patient history)
- Pain scores (VAS) ranging from 3 to 8 points
- Pain located between T12 and gluteal folds(determined via palpation)
- Not having attended Pilates for low back pain for atleast 6 months prior to enrollment
Exclusion Criteria:
- History of spinal surgery, fractures, tumors, infections, or inflammatory spinal disease.
- Pregnant or lactating( strongly contraindicated for whole body vibration due to potential fetal risk and pelvic instability)
- Radicular pain, nerve root compression or neurological deficits.
- Medical comorbidities (e.g cardiovascular, neurological, endocrine or metabolic disease)(5).
- Physical limitations (e.g. orthopedic or rheumatic diseases, muscular injury, fibromyalgia, or pain)that could affect their ability to perform the Pilate exercises.
- Participants whose weight exceeds 150kg ( that's the maximum weight bearing capacity for WBV)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Whole Body Vibration
Participants in this group will receive Whole Body Vibration training using a vibration platform.
Sessions will be conducted 3 times per week for 4 weeks, lasting approximately 20-30 minutes per session.
The protocol will include static and dynamic postures designed to activate lower and upper limb musculature, with incorporated upper limb movements and a 2:1 work-rest ratio
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Whole-body vibration therapy will be delivered using a side-alternating vibration platform under the supervision of a trained physiotherapist. The intervention will be performed 3 sessions per week for 4 weeks. Each session will last 30 minutes, consisting of 10 bouts of 2 minutes vibration followed by 1 minute rest. Vibration parameters will include a frequency of 18 Hz and an amplitude of 2 mm. Participants will maintain a static standing posture with slight knee flexion, slight lumbar lordosis, and head erect. No additional exercises will be performed on the platform to isolate the effect of vibration. Participants will wear socks during the intervention. All participants will also receive conventional physiotherapy, including: Transcutaneous Electrical Nerve Stimulation (TENS): 100 Hz frequency, 200 µs pulse duration, 10 minutes Joint mobilization: oscillations at 1-2 Hz applied for approximately 5 minutes to hypomobile or painful lumbar segments |
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활성 비교기: Pilates
participants in this group will receive a supervised mat-based Pilates program conducted by a trained physiotherapist.
The intervention will be carried out 3 times per week for 4 weeks, with each session lasting approximately 30 minutes.
Exercises will focus on core stability, postural alignment, controlled breathing, and upper limb engagement, performed using an intermittent 2:1 work-rest ratio.
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Mat-based Pilates exercises will be performed under the supervision of a trained physiotherapist. The intervention will be conducted 3 sessions per week for 4 weeks, with each session lasting approximately 30 minutes, using a 2:1 work-rest ratio similar to the WBV group. The program will include: Diaphragmatic breathing: 2 min activity + 1 min rest The Hundred: 2 sets of 2 min with 30 sec rest Roll Up: 5 cycles (40 sec activity + 20 sec rest) Single Leg Circles: small and large circles (40 sec each + 20 sec rest), bilaterally Spine Stretch: 5 cycles (40 sec activity + 20 sec rest) Single Leg Stretch: 4 cycles (40 sec activity + 20 sec rest) Diaphragmatic breathing (cool-down): 2 min activity + 1 min rest Exercises will be performed at low to moderate intensity, focusing on core stabilization, breathing control, flexibility, and controlled movement. All participants will also receive conventional physiotherapy, including TENS (100 Hz, 200 µs, 10 minutes) and lumbar joint mobilizatio |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity
기간: Time Frame: Baseline and 4 weeks (post-intervention).
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Outcome Measure: Change in dynamic balance measured using the Y-Balance Test.
Description: Dynamic balance will be assessed using the Y-Balance Test.
Reach distances in the anterior, posteromedial, and posterolateral directions will be normalized to limb length, and a composite score (%) will be calculated.
Higher composite scores indicate better dynamic balance.
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Time Frame: Baseline and 4 weeks (post-intervention).
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Dynamic Balance
기간: 4 weeks
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Dynamic balance will be assessed using the Y-Balance Test Composite Reach Distance, normalized to limb length. Composite scores range from 0% to 100%. Higher scores indicate better dynamic balance. Unit of Measure: Percent (%) |
4 weeks
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Functional performance
기간: Time Frame: Baseline and 4 weeks (post-intervention).
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Outcome Measure: Change in functional performance measured using the Progressive Isoinertial Lifting Evaluation (PILE). Description: Functional performance will be assessed using the Progressive Isoinertial Lifting Evaluation (PILE), which measures lifting capacity during a standardized lifting task. The primary outcome will be the maximum weight lifted (kg) and the number of completed lifting stages. Higher values indicate better functional performance. |
Time Frame: Baseline and 4 weeks (post-intervention).
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공동 작업자 및 조사자
수사관
- 연구 의자: Shoaib Waqas, Lahore University of Biological and Applied Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.
End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.
IPD 공유 액세스 기준
Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.
End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
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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