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

May 18, 2021 updated by: César Calvo Lobo, Universidad Complutense de Madrid

Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic non-specific low back pain

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypo-pressive abdominal exercise program
Other: Hypo-pressive abdominal exercise intervention
An 8-week hypo-pressive abdominal exercise program
No Intervention: No training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline inspiratory muscle strength at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline diaphragm muscle thickness at 8 weeks
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
Change from baseline pressure pain threshold at 8 weeks
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.
Change from baseline disability at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFV_1/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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