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Completed

NCT Number: NCT04750187

Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain

The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic non-specific low back pain

Exclusion criteria

  • Congenital diseases
  • Rheumatic or neuro-muscular diseases
  • Respiratory conditions
  • Surgery
  • Pregnancy

Treatment and study plan

Hypo-pressive abdominal exercise intervention

Other

An 8-week hypo-pressive abdominal exercise program

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: Change from baseline inspiratory muscle strength at 8 weeks

    Inspiratory muscle strength will be measured in % by a POWER-breathe device

Secondary outcomes

  1. Diaphragm muscle thickness

    Time frame: Change from baseline diaphragm muscle thickness at 8 weeks

    Diaphragm muscle thickness will be measured in mm by an ultrasound device

  2. Pressure pain threshold

    Time frame: Change from baseline pressure pain threshold at 8 weeks

    Pressure pain threshold will be measured in kg/cm2 by an algometer

  3. Disability

    Time frame: Change from baseline disability at 8 weeks

    Pain-related disability score will be measured by the Roland-Morris Disability Questionnaire. Total score ranges from 0 to 24. Higher scores represent higher levels of pain-related disability.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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