Clinical trial NCT06069388: Effectiveness of Diaphragm Treatment in Reducing Low Back Pain
Official title: Benefits of Diaphragm Treatment in Reducing Low Back Pain in Patients With Mechanical Lumbar Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: low back pain
diaphragm
lumbar pain
physiotherapy
conventional
treatment
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Determine the benefits of including a Stretching technique of the anterior part of the diaphragm in the supine position in the conventional physiotherapy treatment protocol applied to insurance company patients with mechanical low back pain.

design: The aim is to carry out an experimental, analytical, prospective, longitudinal, randomized, single-blind study with a blinded evaluator, with an experimental group (EG) to which a manual technique on the diaphragm will be included in the conventional physiotherapy treatment (manual therapy and electrotherapy). and a control group (CG) to which only conventional physiotherapy treatment is administered.

Subject: Patient diagnosed with subacute or chronic mechanical low back pain by a specialist doctor and who has attended in "Fisioclinic" physiotherapy clinic, Older than 18 years-old, Indistinct sex, Diaphragm dysfunction.

Methods: it is proposed to carry out a study in which two groups of subjects with mechanical low back pain will be compared. One group will receive conventional physiotherapy, with electrotherapy and massage therapy, while the other group will receive the same conventional physiotherapy plus a specific technique aimed at the diaphragm muscle. Ten treatment sessions will be carried out daily from Monday to Friday. Different variables will be evaluated using scientifically validated methods, such as manual diagnostic tests for lumbar mobility, algometry to measure muscle pain, cirtometry to evaluate chest mobility, validated questionnaires for quality of life and spirometry to measure respiratory parameters. These variables will be measured before and after each treatment session and later a week, a month and four months after the last intervention.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with subacute or chronic mechanical low back pain by a specialist doctor and who has attended in "Fisioclinic" physiotherapy clinic.

  * Older than 18 years-old.
  * Indistinct sex.
  * Diaphragm dysfunction.

Exclusion Criteria:

* Any surgical intervention on the upper and lower limbs, head, spine, thorax or abdomen at any time in their lives, with a visible anatomy cause on imaging tests.
* Any pathology of non-mechanical origin, such as inflammatory, infectious, tumorous, neurological, traumatic processes and bone diseases in the lumbar spine.
* Having received analgesic or anti-inflammatory medical treatment for pain in a period of less than two weeks.
* Pregnant women, including the breastfeeding period.
* Patients receiving chemotherapy or radiotherapy.
* Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
* Implanted electronic devices.
* Drug or alcohol abuse, analgesic or sedative therapy and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics and anticonvulsants).
* Patients who have previous experience with manual treatment of the diaphragm.
* Patients with high work activity.
* Outside the age range for the study.
* Refusal to participate in the study.
* Refusal to complete and sign the informed consent.

Primary outcomes:
measure: Schober test
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Fingers-Floor Distance (DDS) test
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Measurement of thoracic expansion
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Measurement of respiratory parameters through spirometry
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Evaluation of quality of life using the SF-12 life questionnaire. (quantitative v.)
timeFrame: baseline, pre-intervention/procedure/surgery
Secondary outcomes:
measure: Schober test
timeFrame: immediately after the intervention/procedure/surgery
measure: Fingers-Floor Distance (DDS) test
timeFrame: immediately after the intervention/procedure/surgery
measure: Measurement of thoracic expansion
timeFrame: immediately after the intervention/procedure/surgery
measure: Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
timeFrame: immediately after the intervention/procedure/surgery
measure: Measurement of respiratory parameters through spirometry
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
measure: Schober test
timeFrame: 1 week after last intervention
measure: Fingers-Floor Distance (DDS) test
timeFrame: 1 week after last intervention
measure: Measurement of thoracic expansion
timeFrame: 1 week after last intervention
measure: Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
timeFrame: 1 week after last intervention
measure: Measurement of respiratory parameters through spirometry
timeFrame: 1 week after last intervention
measure: Schober test
timeFrame: 4 weeks after last intervention
measure: Fingers-Floor Distance (DDS) test
timeFrame: 4 weeks after last intervention
measure: Measurement of thoracic expansion
timeFrame: 4 weeks after last intervention
measure: Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
timeFrame: 4 weeks after last intervention
measure: Measurement of respiratory parameters through spirometry
timeFrame: 4 weeks after last intervention
measure: Schober test
timeFrame: 16 weeks after last intervention
measure: Fingers-Floor Distance (DDS) test
timeFrame: 16 weeks after last intervention
measure: Measurement of thoracic expansion
timeFrame: 16 weeks after last intervention
measure: Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
timeFrame: 16 weeks after last intervention
measure: Measurement of respiratory parameters through spirometry
timeFrame: 16 weeks after last intervention
measure: Evaluation of quality of life using the SF-12 life questionnaire. (quantitative v.)
timeFrame: 16 weeks after last intervention
Locations:
city: Sevilla
country: Spain
facility: Juan Antonio Díaz-Mancha
state: Seville
Study officials:
affiliation: University of Seville
name: Juan Antonio Díaz-Mancha, PhD
role: PRINCIPAL_INVESTIGATOR
References: