- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
연구 개요
상세 설명
Lumbar instability is a common medical problem. There is a 50-70% chance of a person suffering from LBP during his or her lifetime having lumbar instability. It is often referred to as clinical spinal instability. Clinical spinal instability is controversial and poorly understood. Properly conducted clinical studies of patients with spinal pain and documented clinical instability would be good to explore this concept. However, pursuing such a course is difficult.
The diaphragm has a dual role in respiration and postural control. Evidence suggests that current core stability exercises for low back pain are superior to minimal or no treatment, however, no more beneficial than general exercises and/or manual therapy. There appears to be a higher focus on the transverses abdominis and multifidi muscles and minimal attention to the diaphragm.
We propose that any form of core stabilization exercises for low back pain rehabilitation should consider the diaphragm. Core stabilization program could commence with facilitation of normal breathing patterns and progressive systematic restoration of the postural control role of the diaphragm muscle.
So, the aim of this trial is to determine whether combining diaphragmatic strengthening exercises with core stability training leads to faster improvements in pain and instability in individuals with lumbar instability, compared to traditional core exercises alone.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ahmed Hesham Abd El-Mawgoud, B.Sc
- 전화번호: +20 11 20484750
- 이메일: ahmed.hesham.hassona@gmail.com
연구 연락처 백업
- 이름: Mona AbdelRaouf Moursy, PhD
연구 장소
-
-
-
Cairo, 이집트
- Outpatient clinic of the faculty of physical therapy, Cairo University
-
연락하다:
- Ahmed Hesham Abd El-Mawgoud, B.Sc
- 전화번호: +20 11 20484750
- 이메일: ahmed.hesham.hassona@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 25 and 35 years.
- Positive prone instability test.
- Straight leg raising >90 degrees.
- Pain assessment on VAS >5/10.
- All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)
Exclusion Criteria:
- Patients with cardiovascular diseases.
- Patients with cerebrovascular diseases.
- Patients with neurological diseases.
- Patients with any attention disorders or physical disability.
- Patients with any diseases/conditions preventing physical activity participation.
- Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
- Patients with central obesity (A waist to hip ratio >0.90 in males or > 0.85 in females).
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: Combined diaphragm strengthening + Core stability exercises
It will include patients that will perform combined diaphragm strengthening and core stability exercises.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
|
Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session).
Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).
Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
|
|
활성 비교기: Core stability exercises
It will include patients that will perform core stability exercises alone.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
|
Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity assessed using the Visual Analogue Scale (VAS)
기간: 8 weeks
|
Pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
8 weeks
|
|
Pressure pain threshold assessed by pressure algometry
기간: 8 weeks
|
Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer.
Higher values indicate reduced pain sensitivity.
|
8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
기간: 8 weeks
|
Core muscle stability will be assessed using a Pressure Biofeedback Unit during abdominal drawing-in tasks.
Improved pressure control indicates better activation of the local stabilizing muscles.
|
8 weeks
|
|
Functional disability assessed using the Oswestry Disability Index (ODI)
기간: 8 weeks
|
Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
Scores range from 0 to 100%, with higher scores indicating greater disability.
|
8 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Ahmad Mahdi Ahmad, PhD, Professor, Cairo University
- 연구 책임자: Maged Mohamed Samy Abouelsoud, PhD, Professor, Ain Shams University
- 연구 책임자: Mona AbdelRaouf Moursy, Assist. Professor, Cairo University
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 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. .