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临床试验/CTRI/2025/03/082921
CTRI/2025/03/082921尚未招募不适用

Effect Of Hypopressive Abdominal Gymnastics On Pain, Flexibility And Function In Individuals With Non-Specific Low Back Pain

Ahmedabad Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

INTRODUCTION

q   Low back pain is a highly prevalent issue with a widespread distribution.

q  It is an omnipresent and often debilitating condition that affects a significant portion of the global population.

q  It is one of the preeminent cause for disability and notably impacts productivity, affecting individuals and healthcare systems worldwide.

q  The majority of low back pain cases are considered non-specific, indicating they lack a clear identifiable pathological cause.

q  Non-specific low back pain includes various pain sensations that cannot be linked to obvious structural issues like fractures, herniated discs, or infections.

q  This wide classification of non-specific low back pain encompasses pain from muscle strain, sprains, bad posture, or overuse, often worsened by psychological factors like stress and anxiety.

q  A research in 2022 found that 66% of the population in India had experienced low back pain at some point in their lifetime.

q  In 1980, Caufriez et al. introduced Hypopressive Abdominal Gymnastics (HAG) to prevent pelvic floor issues post-pregnancy, and later to enhance postural stability.

q  The focus is on exercises for posture that help reduce pressure in the abdominal, perineal, and thoracic cavities.

q  This technique, combined with posture methods, targets activating type I tonic muscle fibers, which should enhance the coordinated activation of all muscles involved in posture, including the deep muscles in the trunk.

q  These exercises could directly engage the transversus abdominis muscle, potentially enhancing the strength of the abdominal wall and better spine stabilization.

q  In terms of postural techniques, HAG involves moving through a series of positions, starting with standing and finishing in a supine position, including kneeling, quadruped, and sitting positions along the way.

NEED OF STUDY

q   Low back pain is the leading cause of disability in terms of years lived with disability (YLDs).

q  So it is essential to integrate innovative methods to accomplish accelerated recovery in individuals with LBP, thus enhancing patient outcomes.

q  Up until now, most studies have concentrated on evaluating the impacts of HAG on pelvic floor dysfunctions. However, there have been few studies that have examined how core muscle groups may assist in stabilizing the spine properly.

q  Henceforth, training the core muscles which generate trunk stability can be beneficial in alleviating low back pain.

q  There are lack of studies assessing the effects of HAG on non-specific low back pain.

q  Therefore, gaining a deeper understanding of the impacts of HAG is essential in order to begin enhancing and refining various intervention guidelines and protocols.

AIM

Ø  To assess the effect of hypopressive abdominal gymnastics on pain, flexibility and function in individuals with non-specific low back pain.

OBJECTIVES

q To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on pain by VAS in individuals with non-specific low back pain.

q  To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility by Sit and Reach test in individuals with non-specific low back pain.

q  To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on function by Modified Oswestry Disability Index (MODI) in individuals with non-specific low back pain.

HYPOTHESIS

Null Hypothesis

q H01 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on pain in individuals with non-specific low back pain.

q  H02 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility in individuals with non-specific low back pain.

q  H03 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on function in individuals with non-specific low back pain.

q  H04 : There is no significant effect of Conventional Therapy on pain in individuals with non-specific low back pain.

q  H05 : There is no significant effect of Conventional Therapy on flexibility in individuals with non-specific low back pain.

q H06 : There is no significant effect of Conventional Therapy on function in individuals with non-specific low back pain.

q H07 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on pain in individuals with non-specific low back pain.

q  H08 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H09 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on function in individuals with non-specific low back pain.

Alternate Hypothesis

q H11 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on pain in individuals with non-specific low back pain.

q  H12 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility in individuals with non-specific low back pain.

q  H13 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on function in individuals with non-specific low back pain.

q  H14 : There is significant effect of Conventional Therapy on pain in individuals with non-specific low back pain.

q  H15 : There is significant effect of Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H16 : There is significant effect of Conventional Therapy on function in individuals with non-specific low back pain.

q H17 : There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on pain in individuals with non-specific low back pain.

q  H18: There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H19: There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on function in individuals with non-specific low back pain.

METHODOLOGY

Ø  Study Design :- An Experimental Study (NRCT)

Ø  Study Duration :- 6 months

Ø  Sample Size :- 36 (18 in each group)

Ø  Sample Design :- Simple random sampling

Ø  Group A :- Hypopressive Abdominal Gymnastics + Conventional Therapy

Ø  Group B :- Conventional Therapy

Ø  Treatment Duration :- 2 weeks

OUTCOME MEASURES

q Pain using Visual Analog Scale (VAS).

q  Flexibility using Sit and Reach Test.

q  Function using Modified Oswestry Disability Index (MODI).

CRITERIA

INCLUSION

•        Individuals between the age of 18-40 years (According to Newman’s Classification)

•        Males and females both

•        Individuals diagnosed with non-specific low back pain persistent for more than a week

•        Visual Analog Scale (VAS) score ranging between 3-7

•        Individuals diagnosed with non-specific low back pain willing to participate

EXCLUSION

•        Patients with cardio-respiratory disease

•        Pregnancy or suspected pregnancy

•        Patients with disc lesion or stenosis

•        Patients with spinal deformities

•        Patients with spondylolysis or spondylolisthesis

•        Neuromuscular conditions or rheumatisms

MATERIALS TO BE USED

Ø  Consent form

Ø   A box about 30 cms or a step

Ø   Ruler

Ø   Plinth or mat

Ø   Hot pack

Ø   Stopwatch

Ø   Paper

Ø   Pen

Ø   Pencil

Ø   Visual Analog Scale (VAS)

Ø   Modified Oswestry Disability Index (MODI)

PROCEDURE

q Ethical clearance from the Institutional Ethics and Research Committee will be taken.

q  After ethical approval the subjects will be screened as per the eligibility of inclusion criteria.

q  Subjects will be explained about the study.

q  A written consent form will be signed by the subjects.

q  The subjects will be divided in two groups.

q  Pre assessment will be taken for pain, flexibility and function.

q  Group A [Experimental group] will receive Hypopressive Abdominal Gymnastics along with Conventional Therapy

q Group B [Control Group] will receive Conventional Therapy.

q  After 2 weeks of treatment, post assessment will be taken.

In group A (experimental group), administer Hypopressive Abdominal Gymnastics along with Conventional Therapy

q Patient position :- Begin with standing

q Procedure :- Hypopressive Abdominal Gymnastics will be carried out based on the principles established by Curifez, Rebullido and Pinsach.(4)

q They detailed the following steps :-

•        Neutral pelvis as well as spine elongation

•        Dorsiflexion of ankles

•        Flexion of knees

•        Shoulder girdle muscle activation

q Now, they will perform 3 normal breathing cycles with slow deep exhalations (inspiration and maximum exhalation).

q  Followed by “diaphragmatic aspiration” maneuver, i.e. breathing maintenance after expansion of rib cage.

q Treatment duration :- 2 weeks, 8 sessions (4 sessions per week)

q Every session includes 6 hypopressive abdominal gymnastics with 2 minutes of rest between each, and each exercise will be done 3 times.

q In group B (control group), Conventional Therapy will be administered.

q Patient position :- Supine lying

q Procedure :- The following protocol is to be followed(19) :-

•        Hot pack application :- 10 minutes

•        Pelvic bridging

•        Pelvic tilt exercises

•        Back extension exercises

•        Static abdominal exercises

•        Knee to chest exercises

•        Curl-ups

•        Lion exercises

•        Cat-camel stretch

•        Static Hamstring stretches :- 30 seconds hold, 3 repetitions(20)

•        Treatment duration :- 2 weeks, 8 sessions (4 sessions per week)

•        Each exercise will have 10 repetitions and one set will be performed.

STATISTICAL ANALYSIS

Ø  Suitable statistical tests depending upon the distribution of data would be applied.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Individuals diagnosed with non-specific low back pain persistent for more than a week Visual Analog Scale (VAS) score ranging between 3-7.

排除标准

  • Patients with cardio-respiratory disease Pregnancy or suspected pregnancy Patients with disc lesion or stenosis Patients with spinal deformities Patients with spondylolysis or spondylolisthesis Neuromuscular conditions or rheumatisms.

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: Before treatment at baseline and after 2 weeks of treatment | On activity and at rest

次要结局

  • Modified Oswestry Disability Index(Before treatment at baseline and after 2 weeks of treatment)
  • Flexibility using Sit And Reach Test(Before treatment at baseline and after 2 weeks of treatment)

研究者

发起方
Ahmedabad Institute Of Medical Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Samridhi

Ahmedabad Institute Of Medical Sciences

研究点 (1)

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