- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07610044
Pelvic Floor Exercises Versus Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain
Comparative Effects of Pelvic Floor Muscle Exercises and Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
Non-specific chronic low back pain is a common musculoskeletal disorder associated with pain, restricted lumbar mobility, and reduced functional capacity. Weakness of core stabilizing muscles contributes significantly to spinal instability and persistent symptoms.
Exercise-based physiotherapy interventions including pelvic floor muscle exercises and swiss ball exercises are commonly used to improve core stability, lumbar mobility, muscle endurance, and pain management.
This randomized controlled trial will compare the effects of:
Baseline physiotherapy alone Baseline physiotherapy combined with swiss ball exercises Baseline physiotherapy combined with pelvic floor muscle exercises
A total of 69 participants will be randomly allocated into three parallel groups. Outcome measures including pain, disability, lumbar range of motion, and muscle endurance will be assessed before and after intervention.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄
- University of Lahore
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Females aged 18-35 years
- Chronic non-specific low back pain for more than 3 months
- Restricted lumbar range of motion
- Positive straight leg raise test
- Positive femoral nerve tension test
- Positive slump test
- Willing to participate in the study
Exclusion Criteria:
- Previous or planned spinal surgery
- Pelvic floor surgery or abdominal surgery
- Pregnancy or postnatal period
- Urinary incontinence
- Neurological motor weakness or deformity
- Spinal stenosis
- Osteoporosis
- Disc herniation
- Degenerative or inflammatory spinal conditions
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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활성 비교기: Control Group (Baseline Physiotherapy)
Participants will receive baseline physiotherapy treatment including heating pad application, stretching exercises, and strengthening exercises.
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Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
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실험적: Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy)
Participants will receive baseline physiotherapy combined with swiss ball exercises including curl-up, bridging, and front plank exercises.
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Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
Swiss ball exercises include curl-up, bridging, and front plank exercises performed on a swiss ball to improve core stability, balance, and muscle endurance.
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실험적: Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy)
Participants will receive baseline physiotherapy combined with pelvic floor muscle exercises for core stabilization and pain reduction.
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Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
Pelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Pain Severity Measured by Revised Short McGill Pain Questionnaire-2 (SF-MPQ-2)
기간: Baseline and 6 weeks after intervention
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Pain severity and pain quality will be assessed using the Revised Short McGill Pain Questionnaire Version-2 (SF-MPQ-2).
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Baseline and 6 weeks after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Functional Disability Measured by Oswestry Disability Index (ODI)
기간: Baseline and 6 weeks after intervention
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Functional disability associated with chronic low back pain will be measured using the Oswestry Disability Index questionnaire.
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Baseline and 6 weeks after intervention
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Change in Lumbar Range of Motion Measured by Inclinometer
기간: Baseline and 6 weeks after intervention
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Lumbar flexion, extension, lateral flexion, and rotation range of motion will be measured using an inclinometer.
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Baseline and 6 weeks after intervention
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Change in Core Muscle Endurance Measured by Pressure Biofeedback Unit
기간: Baseline and 6 weeks after intervention
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Core muscle endurance including transverse abdominis, quadratus lumborum, and pelvic floor muscles will be measured using a pressure biofeedback unit.
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Baseline and 6 weeks after intervention
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
- Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
- Amundsen PA, Evans DW, Rajendran D, Bright P, Bjorkli T, Eldridge S, Buchbinder R, Underwood M, Froud R. Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord. 2018 Apr 12;19(1):113. doi: 10.1186/s12891-018-2034-6.
- Custers P, Van de Kelft E, Eeckhaut B, Sabbe W, Hofman A, Debuysscher A, Van Acker G, Maes G. Clinical Examination, Diagnosis, and Conservative Treatment of Chronic Low Back Pain: A Narrative Review. Life (Basel). 2024 Aug 29;14(9):1090. doi: 10.3390/life14091090.
- Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.
- de Souza IMB, Sakaguchi TF, Yuan SLK, Matsutani LA, do Espirito-Santo AS, Pereira CAB, Marques AP. Prevalence of low back pain in the elderly population: a systematic review. Clinics (Sao Paulo). 2019 Oct 28;74:e789. doi: 10.6061/clinics/2019/e789. eCollection 2019.
- Choi, Y., & Lee, S. (2021). Effects of pressure biofeedback application location for subjects with lumbar instability on pelvic rotation and hip joint abductor muscle activity during the Clam exercise. Physical Therapy Rehabilitation Science, 10(2), 90-97.
- Casiano, V. E., Sarwan, G., Dydyk, A. M., & Varacallo, M. (2023). Back pain. In StatPearls [Internet]. StatPearls Publishing.
- Bernard S, Gentilcore-Saulnier E, Masse-Alarie H, Moffet H. Is adding pelvic floor muscle training to an exercise intervention more effective at improving pain in patients with non-specific low back pain? A systematic review of randomized controlled trials. Physiotherapy. 2021 Mar;110:15-25. doi: 10.1016/j.physio.2020.02.005. Epub 2020 Mar 2.
- Bandy, W. D., & Lairamore, C. (2023). MEASUREMENT of RANGE of MOTION of the THORACIC and LUMBAR SPINE. Joint Range of Motion and Muscle Length Testing-E-Book: Joint Range of Motion and Muscle Length Testing-E-Book, 235.
- Atalay E, Akova B, Gur H, Sekir U. Effect of Upper-Extremity Strengthening Exercises on the Lumbar Strength, Disability and Pain of Patients with Chronic Low Back Pain: A Randomized Controlled Study. J Sports Sci Med. 2017 Dec 1;16(4):595-603. eCollection 2017 Dec.
- Arovah, N. I., Agustiningtyas, I., & Pratiwi, K. S. (2025). Concurrent and Convergent Validity of Goniometers Versus Bubble Inclinometers in Measuring Thoracolumbar Movement in Low Back Pain Patients. Medical Rehabilitation, 28(3), 27-34.
- Altman BM. Definitions, concepts, and measures of disability. Ann Epidemiol. 2014 Jan;24(1):2-7. doi: 10.1016/j.annepidem.2013.05.018. Epub 2013 Oct 29.
- Aksen-Cengizhan, P., Onay, D., Sever, O., & Doğan, A. A. (2018). A comparison between core exercises with Theraband and Swiss Ball in terms of core stabilization and balance performance. Isokinetics and exercise science, 26(3), 183-191.
- Abdel-Aziem AA, Abdelraouf OR, El-Basatiny HMY, Draz AH. The Effects of Stabilization Exercises Combined With Pelvic Floor Exercise in Women With Nonspecific Low Back Pain: A Randomized Clinical Study. J Chiropr Med. 2021 Dec;20(4):229-238. doi: 10.1016/j.jcm.2021.12.008. Epub 2022 Apr 6.
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
기타 연구 ID 번호
- UOL/IREB/25/15/03/33
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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