- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07727525
Core Strengthening Effects in Low Back Pain in Overweight Adults (CORE-BACK)
Effects of Core Strengthening on Mechanical Low Back Pain in Overweight Adults.
Mechanical low back pain is one of the most common musculoskeletal disorders among overweight adults and can lead to pain, disability, and reduced quality of life. Weakness of the core muscles may contribute to poor spinal stability and persistence of symptoms. Core strengthening exercises have been proposed as an effective treatment; however, evidence regarding their additional benefit over conventional physical therapy remains limited.
This randomized controlled trial aimed to determine the effects of adding core strengthening exercises to conventional physical therapy in overweight adults with mechanical low back pain. Sixty participants aged 25-45 years with a body mass index (BMI) of 25 kg/m² or greater and chronic mechanical low back pain lasting more than three months were randomly assigned to either an experimental group or a control group.
The experimental group received core strengthening exercises (planks, side planks, and superman exercises) in addition to conventional physical therapy, while the control group received conventional physical therapy alone. Both groups also received therapeutic hot packs and transcutaneous electrical nerve stimulation (TENS). Participants attended three treatment sessions per week for six weeks.
Primary outcomes included pain intensity measured by the Numeric Pain Rating Scale (NPRS), functional disability measured by the Oswestry Disability Index (ODI), and body fat percentage measured using the Jackson-Pollock skinfold method. Outcomes were assessed before and after the six-week intervention.
The study evaluated whether adding core strengthening exercises to conventional physical therapy provides greater improvements in pain, disability, and body fat percentage in overweight adults with mechanical low back pain.
연구 개요
상태
상세 설명
Mechanical low back pain (MLBP) is a common musculoskeletal condition and one of the leading causes of disability worldwide. Overweight and obesity increase the mechanical load on the lumbar spine, alter spinal biomechanics, and contribute to reduced physical function and persistent pain. Excess body weight, decreased physical activity, and weakness of the trunk musculature may further compromise spinal stability, increasing the likelihood of chronic low back pain.
Core muscles, including the transversus abdominis, multifidus, erector spinae, diaphragm, pelvic floor muscles, rectus abdominis, and internal and external oblique muscles, play an essential role in maintaining spinal stability and functional movement. Strengthening these muscles may improve trunk stability, reduce mechanical stress on the lumbar spine, decrease pain, and enhance functional ability. Although several studies have investigated core stabilization exercises, evidence regarding their effectiveness in overweight adults with mechanical low back pain remains inconclusive.
This study was designed as a single-blinded randomized controlled trial to compare the effects of conventional physical therapy alone with conventional physical therapy combined with core strengthening exercises in overweight adults with chronic mechanical low back pain.
A total of 60 participants aged 25-45 years with chronic mechanical low back pain of more than three months' duration, BMI ≥25 kg/m², body fat percentage greater than 25%, and Numeric Pain Rating Scale scores below 7 were enrolled. Participants with non-mechanical low back pain, previous lumbar spine surgery, spinal fractures, spondylolisthesis, osteoporosis, neurological disorders, metabolic diseases, spinal trauma, or other serious spinal pathology were excluded.
Eligible participants were randomly allocated into two equal groups.
Experimental Group
Core strengthening exercises:
Plank Side plank Superman exercise
Conventional exercises:
Bridging Knee-to-chest exercise Back extension Pelvic rotation
Baseline physical therapy:
Therapeutic hot pack Continuous Transcutaneous Electrical Nerve Stimulation (TENS) for 10 minutes
Control Group
Conventional exercises:
Bridging Knee-to-chest exercise Back extension Pelvic rotation
Baseline physical therapy:
Therapeutic hot pack Continuous TENS for 10 minutes
Participants attended three supervised treatment sessions per week for six consecutive weeks (18 treatment sessions). Each exercise was performed for 10 repetitions with a 10-second hold and standardized rest intervals. Participants were advised to avoid heavy physical activities throughout the intervention period.
Outcome measures were assessed at baseline and after completion of the intervention. Pain intensity was evaluated using the Numeric Pain Rating Scale (NPRS). Functional disability was assessed using the Oswestry Disability Index (ODI). Body fat percentage was measured using the Jackson-Pollock three-site skinfold method.
Data analysis was performed using SPSS version 21. Normality of data distribution was assessed using the Kolmogorov-Smirnov test. Because several variables were not normally distributed, non-parametric statistical tests were used. Between-group comparisons were analyzed using the Mann-Whitney U test, while within-group pre- and post-treatment comparisons were analyzed using the Wilcoxon Signed-Rank test. Statistical significance was established at a p-value less than 0.05.
The study investigated whether the addition of core strengthening exercises to conventional physical therapy would provide greater reductions in pain intensity, disability, and body fat percentage than conventional therapy alone in overweight adults with chronic mechanical low back pain. The findings are expected to contribute to evidence-based rehabilitation strategies for managing mechanical low back pain in overweight individuals and assist clinicians in selecting effective exercise interventions for this patient population.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄
- Elite Physical Therapy Centre
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Male and female participants. Age between 25 and 45 years. Diagnosed with chronic mechanical low back pain lasting more than 3 months. Body Mass Index (BMI) ≥ 25 kg/m² (overweight or obese). Body fat percentage > 25%. Numeric Pain Rating Scale (NPRS) score < 7 at baseline. Able and willing to provide written informed consent. Willing to participate in the complete 6-week intervention program.
Exclusion Criteria:
Non-mechanical low back pain. Acute low back pain. Previous lumbar spine surgery (e.g., laminectomy or discectomy). Spondylolisthesis. Osteoporosis or spinal fractures. Cauda equina syndrome. Current history of spinal trauma or surgery. Lumbar spine myelopathy. Diagnosed metabolic diseases. Neurological disorders affecting the spine or lower limbs. Any medical condition that would contraindicate participation in the exercise program.
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 |
|---|---|
|
실험적: Experimental Group (Core Strengthening + Conventional Physical Therapy)
Participants assigned to the experimental arm received a combination of core strengthening exercises (plank, side plank, and superman exercises) together with conventional physical therapy exercises (bridging, knee-to-chest, back extension, and pelvic rotation).
All participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes.
Treatment was provided three times per week for six weeks (18 sessions).
|
Participants received a supervised exercise program consisting of core strengthening exercises (plank, side plank, and superman exercises) in addition to conventional physical therapy exercises (bridging, knee-to-chest, back extension, and pelvic rotation).
Each exercise was performed for 10 repetitions with a 10-second hold.
Participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes before exercise.
Treatment was provided three sessions per week for six weeks (18 sessions).
Participants received conventional physical therapy consisting of bridging, knee-to-chest, back extension, and pelvic rotation exercises.
Each exercise was performed for 10 repetitions with a 10-second hold.
Participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes before exercise.
Treatment was provided three sessions per week for six weeks (18 sessions).
|
|
활성 비교기: Control Group (Conventional Physical Therapy)
Participants assigned to the control arm received conventional physical therapy consisting of bridging, knee-to-chest, back extension, and pelvic rotation exercises.
All participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes.
Treatment was provided three times per week for six weeks (18 sessions).
|
Participants received a supervised exercise program consisting of core strengthening exercises (plank, side plank, and superman exercises) in addition to conventional physical therapy exercises (bridging, knee-to-chest, back extension, and pelvic rotation).
Each exercise was performed for 10 repetitions with a 10-second hold.
Participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes before exercise.
Treatment was provided three sessions per week for six weeks (18 sessions).
Participants received conventional physical therapy consisting of bridging, knee-to-chest, back extension, and pelvic rotation exercises.
Each exercise was performed for 10 repetitions with a 10-second hold.
Participants also received a therapeutic hot pack and continuous transcutaneous electrical nerve stimulation (TENS) for 10 minutes before exercise.
Treatment was provided three sessions per week for six weeks (18 sessions).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity
기간: Baseline and after 6 weeks of intervention
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Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower scores indicate reduced pain intensity.
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Baseline and after 6 weeks of intervention
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Functional Disability
기간: Baseline and after 6 weeks of intervention
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Functional disability will be measured using the Oswestry Disability Index (ODI).
The ODI is a validated questionnaire that evaluates disability associated with low back pain.
Lower scores indicate better functional status.
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Baseline and after 6 weeks of intervention
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Body Fat Percentage
기간: Baseline and after 6 weeks of intervention
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Body fat percentage will be measured using the Jackson-Pollock three-site skinfold method with skinfold calipers.
Changes in body fat percentage will be compared before and after the intervention.
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Baseline and after 6 weeks of intervention
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공동 작업자 및 조사자
수사관
- 연구 의자: Dr Jawad Naveed, MS, Riphah College of Rehabilitation & Allied Health Sciences, Riphah International University, Islamabad
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- RIPHAH/RCRS/REC/Letter- 01410
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
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