NCT06375018

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

April 16, 2024

Last Update Submit

September 2, 2024

Conditions

Keywords

DiaphragmLow Back PainOsteopathyOsteopathic MedicineStretching TechniqueYoung Adults

Outcome Measures

Primary Outcomes (4)

  • Change in level of inspiratory capacity immediately after 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

    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

    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

    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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

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.

Control group

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.

Experimental group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (50)

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natália MO Campelo, PhD

    Escola Superior de Saúde do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations