Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain

September 2, 2024 updated by: Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto

Effect of the Diaphragm Stretching Technique on Symptomatology in Young Adults With Nonspecific Low Back Pain: Randomized Controlled Trial

This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Nonspecific low back pain occurs when there is an imbalance in the lower back between functional load and the ability to perform daily tasks. It is characterized as such when there is no specific and well-determined diagnosis and there are no structural changes.

The diaphragm and abdominal muscles together create a hydraulic effect in the abdominal cavity, which helps stabilize the spine, providing rigidity to the lumbar spine by increasing intra-abdominal pressure. Diaphragmatic changes in patients diagnosed with low back pain may contribute to the lack of spinal control activity through several mechanisms. Thus, it is concluded that the diaphragm is anatomically related to the lumbar spine, through its muscle fibers.

There are articles that relate the topic of low back pain with Osteopathic Manual Treatment, demonstrating that, despite this lack of scientific evidence, the results obtained at a clinical level are favorable.

This study aims to evaluate the effectiveness of diaphragm stretching techniques on symptoms experienced by young adults with non-specific low back pain.

In this study, the investigators will analyze the effects of the diaphragm stretching technique on the following variables: the sniff nasal inspiratory pressure test (SNIP test) , Visual Analogue Scale (VAS) score, the Schober test and measurement of the distance between the fingers and the ground during anterior flexion of the trunk, without flexion of the lower limbs (also known as the Finger Tip Test).

Study Type

Interventional

Enrollment (Estimated)

45

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 Contact

  • Name: Natália MO Campelo, PhD
  • Phone Number: +35122 206 1000
  • Email: nmc@ess.ipp.pt

Study Locations

  • Portugal
      • Porto, Portugal, 4200-072
        • Escola Superior de Saúde do Porto

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nonspecific low back pain;
  • Age between 18 and 30.

Exclusion Criteria:

  • Serious cardiovascular and cardiorespiratory causes;
  • Spinal pathologies and injuries to the lumbar spine;
  • Cancer patients;
  • Pacemaker or implant carriers;
  • Pregnant women or volunteers suspected of being pregnant.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
After data collection, each volunteer will undergo a simulated technique within this group. The investigator will mimic the contacts of the phrenic nerve inhibition technique without applying traction or compression to the tissue, merely maintaining the contacts for the same duration as described in the technique performed in the experimental group, along with the same rest period afterward. Subsequently, new data will be collected following the simulated intervention.
Other: Placebo Technique
In the control group, manual contact will be carried out without any therapeutic intention. This contact will be maintained for the same period of time as the experimental group.
Experimental: Experimental group
After collecting data from each volunteer, a Diaphragm Stretching technique will be administered to individuals in this group. The technique will be executed for a maximum duration of 4 minutes. Following the technique, volunteers will be required to rest for 5 minutes. Subsequently, another round of data collection will be conducted.
Other: Diaphragm Stretching
The participant will be in supine position and the researcher will be at the headrest of the examination table, placing his hands on the lower costal margin. Superior direction traction is performed during inspiration, remaining during expiration. The procedure is repeated for a maximum period of 4 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of inspiratory capacity immediately after intervention
Time Frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the respiratory pressure meter.
Immediately after the intervention
Change in the level of disability derived from low back pain immediately after the intervention
Time Frame: Immediately after the intervention
Assessment instruments to evaluate the degree of disability resulting from low back pain include the Visual Analogue Scale. In this scale, a higher score indicates a greater level of pain, correlating with a worse outcome. Conversely, a lower score indicates less pain, corresponding to a better outcome.
Immediately after the intervention
Change in the level of functionality of the lumbar spine immediately after the intervention
Time Frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the Schober test.
Immediately after the intervention
Change in the level of functionality of the lumbar spine immediately after the intervention
Time Frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the measurement of the distance from the hands to the floor after forward flexion of the trunk while standing with knee extension (also known as the Finger Tip Test).
Immediately after the intervention

Collaborators and Investigators

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

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, PhD, Escola Superior de Saúde do Porto

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OST1_011

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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