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临床试验/CTRI/2025/05/086937
CTRI/2025/05/086937尚未招募1 期

Effect of ktaping and crocodile breathing exercise on respiratory muscle in patient with chronic Non-specific low back pain : A Randomized controlled trial

Sakshi Gupta1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1)Pain – VISUAL ANALOG SCALE

研究概览

简要总结

Low back pain (LBP) is a common condition affecting up to 84% of people, often leading to disability, reduced quality of life, and high healthcare costs. Most cases are nonspecific, with no clear cause, and often result from spinal instability. The diaphragm, which attaches to the lumbar spine, plays a key role in stabilizing the spine through intra-abdominal pressure. In people with LBP, diaphragm function is often impaired, leading to poor posture and increased pain. Breathing exercises like crocodile breathing and kinesio taping can help improve diaphragm activation, posture, and reduce pain.

The aim of this study is to evaluate the effect of K-Taping and crocodile breathing exercises on respiratory muscle strength in patients with chronic non-specific low back pain. The objectives include assessing the impact of Interferential Therapy (IFT) and spinal-based exercises on pain, respiratory muscle strength, and quality of life in these patients. Additionally, the study seeks to determine the combined effect of K-Taping and crocodile breathing exercises when integrated with IFT and spinal-based exercises. Finally, it aims to compare the outcomes between patients receiving only IFT and spinal-based exercises and those receiving the combination of IFT, spinal-based exercises, K-Taping, and crocodile breathing exercises.

METHODOLOGY

STUDY DESIGN                               :  Experimental study design

   STUDY SETTING                             :  DR. D.Y. PATIL COLLEGE OF

PHYSIOTHERAPY, PUNE

 TARGET POPULATION                  :   patient coming to OPD

 SAMPLE POPULATION                  :   patient with Chronic Non-specific low back pain

 SAMPLING METHOD                     :   convenient sampling

 SAMPLE SIZE                                   :     60 (Calculated by statistician)

 SAMPLE DESIGN                             :   experimental study design

The study will be conducted at Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune, following approval from the academic committee. Participants will be selected based on inclusion and exclusion criteria, and informed written consent will be obtained. The procedure and interventions will be explained in detail, with time allotted for any questions. Pre-assessments will be conducted with the participant seated. Kinesio taping will be applied to the diaphragm while the participant is standing in a breath-out position. Interventions, including crocodile breathing exercises and spinal-based exercises, will be performed on a plinth. Interferential Therapy (IFT) will be administered using a carrier frequency of 4000 Hz, with amplitude modulation of 80 Hz, for 20 minutes. Spinal-based exercises will include bridging, posterior pelvic tilt, and strengthening exercises for back and abdominal muscles, performed in 15–20 repetitions. K-Taping will be applied to the diaphragm and replaced weekly. Crocodile breathing will be practiced for 10 minutes daily. The entire protocol will continue for four weeks, with sessions scheduled at approximately the same time each day for consistency.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Non-specific low back pain patients 2)Male and female age 20–50-year-old 3) Patient with VAS score of 4 or higher.

排除标准

  • elderly population above 50 2)back pain severe and require surgery 3)patient having difficulty performing breathing exercise 4)unwilling to participate.

结局指标

主要结局

1)Pain – VISUAL ANALOG SCALE

时间窗: week 0 and week 4

2)Diaphragmatic function – respiratory meter PiMax pMax through RPM device

时间窗: week 0 and week 4

次要结局

  • Functional assessment – ROLAND MORRIS DISABILITY INDEX

研究者

发起方
Sakshi Gupta
申办方类型
Other [self]

研究点 (1)

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