NCT07570641

Brief Summary

The purpose of this study was to investigate the effects of combined diaphragmatic breathing and trunk stabilization exercises on pain, function, and muscle activity in patients with chronic low back pain, and to compare its clinical effectiveness with trunk stabilization exercise alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Pain intensity was measured using the Visual Analogue Scale (VAS), a 0-10 cm scale where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Baseline and after 4 weeks

Secondary Outcomes (1)

  • Functional disability

    Baseline and after 4 weeks

Other Outcomes (1)

  • Muscle activity

    Baseline and after 4 weeks

Study Arms (2)

The combined diaphragmatic breathing and trunk stabilization exercise group

EXPERIMENTAL

The combined diaphragmatic breathing and trunk stabilization exercise group performed trunk stabilization exercises consisting of dead bug, bridge, side plank, and bird dog, with additional diaphragmatic breathing exercise.

Behavioral: trunk stabilization exerciseBehavioral: diaphragmatic breathing exercise

The trunk stabilization exercise group

ACTIVE COMPARATOR

The trunk stabilization exercise group performed trunk stabilization exercises consisting of dead bug, bridge, side plank, and bird dog

Behavioral: trunk stabilization exercise

Interventions

Trunk stabilization exercises consisting of dead bug, bridge, side plank, and bird dog were performed for 10 repetitions in 3 sets, while the side plank was performed for 5 repetitions with a 10-second hold for 3 sets. Rest intervals between sets were set at 1 minute.

The combined diaphragmatic breathing and trunk stabilization exercise groupThe trunk stabilization exercise group

diaphragmatic breathing exercise was performed in a crook-lying position with one hand placed on the sternum and the other on the abdomen. Participants were instructed to inhale through the nose for 5 seconds, allowing lateral expansion of the rib cage, and exhale through pursed lips for 10 seconds while minimizing chest movement. The breathing exercise was performed for 10 repetitions in 3 sets with 1-minute rest between sets.

The combined diaphragmatic breathing and trunk stabilization exercise group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with low back pain lasting at least 3 months (12 weeks)
  • Individuals with a pain intensity of 3 or higher on the Visual Analogue Scale (VAS)
  • Individuals who are physically capable of performing trunk stabilization and diaphragmatic breathing exercises

You may not qualify if:

  • Individuals with neurological or musculoskeletal disorders
  • Pregnant individuals
  • Individuals with fractures or deformities of the spine or related areas
  • Individuals with sensory deficits
  • Individuals who engaged in activities that could affect the study results (e.g., medication use, alcohol consumption, or excessive exercise) within 24 hours prior to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private exercise facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The effects of combined diaphragmatic breathing and trunk stabilization exercises on pain, function and muscle activity in patients with chronic low back pain

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start

February 23, 2025

Primary Completion

February 23, 2025

Study Completion

April 8, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical and privacy considerations.

Locations