Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000643471
Ethics application status
Approved
Date submitted
8/05/2025
Date registered
18/06/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
18/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Diaphragmatic Exercises on Low Back Pain Rehabilitation
Scientific title
Impact of Diaphragmatic Functionality on the Rehabilitation of Nonspecific Low Back Pain: A Randomized Clinical Trial
Secondary ID [1] 314411 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DF-LBP (Diaphragm Function in Low Back Pain)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonspecific low back pain 337429 0
Condition category
Condition code
Musculoskeletal 333805 333805 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental Group:
Participants will perform the same core stabilization exercises as the control group, in addition to six diaphragmatic and costal mobilization exercises:
1. Supine diaphragmatic breathing with knees flexed
2. Right lateral diaphragmatic breathing
3. Left lateral diaphragmatic breathing
4. Diaphragmatic breathing in quadruped position
5. Seated diaphragmatic breathing
6. 90/90/90 diaphragmatic breathing (supine with hips, knees, and ankles at 90° flexion)

Each exercise will be performed for 2 sets of 5 repetitions, totaling approximately 10 minutes of additional time compared to the control group. The full session including both control and experimental group exercises lasts approximately 35 minutes.

Sessions will be delivered individually in-person at a physiotherapy clinic setting (Olimpyafisio Clinic, Rivas-Vaciamadrid, Madrid, Spain).
To monitor intervention fidelity, the physiotherapist will maintain attendance logs, and participants will record compliance using a paper exercise diary verified at each session. The sessions will be realized individually.
Intervention code [1] 331019 0
Rehabilitation
Comparator / control treatment
Arm 1 - Control Group:
Participants will perform core stabilization exercises based on the Pilates method, including exercises such as Cleopatra, Roll up, Roll down, Mini squat, Hip twist, Hip bridge, Quadruped with leg raise, Ball and extend, Scissors, Leg lifts and lowers, Side plank, and Plank. The sessions will last 25 minutes, with 2 sets of 5 repetitions each, 3 times a week for 4 weeks, with one rest day between sessions.
Control group
Active

Outcomes
Primary outcome [1] 341393 0
Diaphragm thickness
Timepoint [1] 341393 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.
Primary outcome [2] 341394 0
Pain intensity
Timepoint [2] 341394 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.
Primary outcome [3] 341395 0
Diaphragm thickening fraction
Timepoint [3] 341395 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.
Secondary outcome [1] 447380 0
Lumbar flexion range of motion
Timepoint [1] 447380 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.
Secondary outcome [2] 447381 0
Urinary incontinence
Timepoint [2] 447381 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.
Secondary outcome [3] 447385 0
Functional disability
Timepoint [3] 447385 0
At baseline, weeks 4 and 8 weeks post-commencement of intervention.

Eligibility
Key inclusion criteria
Adults aged 30 to 60 years

Chronic nonspecific low back pain for at least 3 months

No radiculopathy, respiratory, or cardiac conditions
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

Radiculopathies

Chronic respiratory or cardiac diseases

Autoimmune, neurological, or spinal cord conditions

Phrenic nerve paralysis

Abdominal surgeries (e.g., abdominoplasty)

Bladder or uterine prolapse

Recent treatment within the last 2 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized (1:1 ratio) with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Excel)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using SPSS 29.0. Normal distribution will be tested using the Shapiro-Wilk test. Repeated measures ANOVA will be used for normally distributed data, with effect sizes reported as partial eta squared. Non-parametric data will be analyzed using appropriate tests. A significance level of p < 0.05 will be applied.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2025
Actual
Date of last participant enrolment
Anticipated
27/02/2026
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment outside Australia
Country [1] 27056 0
Spain
State/province [1] 27056 0
Madrid

Funding & Sponsors
Funding source category [1] 318935 0
Self funded/Unfunded
Name [1] 318935 0
Country [1] 318935 0
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 321404 0
None
Name [1] 321404 0
Address [1] 321404 0
Country [1] 321404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317546 0
Hospital Clínico San Carlos
Ethics committee address [1] 317546 0
Ethics committee country [1] 317546 0
Spain
Date submitted for ethics approval [1] 317546 0
16/10/2024
Approval date [1] 317546 0
30/01/2025
Ethics approval number [1] 317546 0
25/032-E

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141394 0
Dr Ángel González de la Flor
Address 141394 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 141394 0
Spain
Phone 141394 0
+34667427424
Fax 141394 0
Email 141394 0
[email protected]
Contact person for public queries
Name 141395 0
Ángel González de la Flor
Address 141395 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 141395 0
Spain
Phone 141395 0
+34667427424
Fax 141395 0
Email 141395 0
[email protected]
Contact person for scientific queries
Name 141396 0
Ángel González de la Flor
Address 141396 0
Universidad Europea de Madrid– Facultad de Medicina, Salud y Deporte. Calle Tajo, s/n Urb. El Bosque. 28670, Villaviciosa de Odón, Madrid,
Country 141396 0
Spain
Phone 141396 0
+34667427424
Fax 141396 0
Email 141396 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data (IPD) will not be made publicly available.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    25.032-E Dictamen favorable.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.