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临床试验/NCT07167212
NCT07167212撤回不适用

Comparative Effect of Diaphragmatic Training and Myofascial Release on Pain Flexibility and Disability in Patients With Chronic Non-specific Low Back Pain

Rashid Latif Medical College1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
44
试验地点
1
主要终点
Pain Level

研究概览

简要总结

Background: The diaphragm muscle is a respiratory muscle with postural function. Patients with chronic LBP (CLBP) are more susceptible to diaphragm fatigue than healthy people and, therefore, can likely benefit from exercises designed to improve strength/endurance in this muscle. Studying the results of diaphragmatic training versus myofascial release was a strategy for determining which of them was the most effective in improving pain, flexibility and disability in the patients with chronic non- specific low back pain.

Objective: The objective of the study will be to compare the effect of Diaphragm training and myofascial release back pain patients.

Methods: A randomized clinical trial will be conducted on 44 patients aged 20-45 years. The patients will be randomized using lottery method. Group A will underwent diaphragmatic training with four positions with hot-pack and therapeutic ultrasound as baseline treatment NPRS will be used to measure the intensity of pain, ODI for the measurement of disability and Schober's test for lumbar flexibility before and after the completion of treatment sessions. Group B will receive myofascial release of diaphragm for 15 minutes with two sets of repetition of 10 breaths with a one-minute interval between them. Total duration will be 4 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •with intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to
  • •All participants will be active at a recreational level, history of at least 12 weeks of NLBP, absence of radiculopathy or spinal damage due to tumors, stenosis, or fractures, and a minimum level of physical activity to be able to perform the exercises.

排除标准

  • •lumbar surgery experience,
  • •inflammatory spinal disease,
  • •spinal deformities,
  • •neurologic radiating pain

研究组 & 干预措施

Diaphragm Training

Experimental

Diaphragm Training

干预措施: Diaphragm Training (Other)

Myofascial Release technique

Active Comparator

Myofascial Release technique

干预措施: Myofascial Release Technique (Other)

结局指标

主要结局

Pain Level

时间窗: Pre-intervention and 4 weeks Post-intervention

Pain level will be assessed by the Numerical Rating Scale (NRS). The participants rated their pain on a defined 0-10 scale, where 0 is no pain, and 10 is the worst pain imaginable. NRS has different advantages, such as simplicity, reproducibility, and sensitivity to small changes in pain. NRS takes less than 1 min to complete and is a valid and reliable scale to measure pain intensity

Disability

时间窗: Pre and 4 week post-intervention

The disability due to NSLBP will be assessed using the Oswestry Disability Index (ODI), which is a self-administered questionnaire to evaluate the limitations of various daily living activities. The ODI is one of the most common scoring systems used for patients with LBP. The total score ranges from 0 to 100, where a higher score indicates a higher level of disability.

Flexibility

时间窗: Pre and 4 weeks Post intervention

The lumbar flexibility will be measured by Modified Schober test. The examiner puts his thumbs on the inferior margin of the subject's PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the examiner holds the tape firmly against the subject's skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion. Each therapist recorded measurements to the nearest mm

次要结局

未报告次要终点

研究者

发起方
Rashid Latif Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleena Waheed

Senior Lecturer

Rashid Latif Medical College

研究点 (1)

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