Effectiveness of Diaphragm Treatment in Reducing Low Back Pain

University of Seville

Status: Enrolling

Conditions: Low Back Pain, Mechanical

Treatments: Procedure: conventional therapy; Procedure: diaphragm technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06069388

DIAFRAGMA

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Diaphragm technique

Experimental group

Description:

The continuity between the diaphragm and the lumbar spine demonstrates the existence of an anatomical and functional connection between them. Changes in the mobility of the diaphragmatic domes in addition to improvement in spirometric parameters when carrying out a diaphragm stretching technique. This makes us think that the mobility of the lumbar spine may be compromised by diaphragm dysfunction.

Treatment:

Procedure: diaphragm technique

Procedure: conventional therapy

conventional physiotherapy

Active Comparator group

Description:

Application of the tetrapolar transcutaneous electrical neurostimulation (TENS) device with the "I-tech Mio-care" equipment in the analgesia program with an intensity of between 10-20 milliamps, according to the patient's tolerance, with an application time of 15 minutes in the lumbar paravertebral area on both sides. 250w infrared lamp at a distance of 1m from the patient, with an application time of 10 minutes. Ultrasound on the quadratus lumborum muscle area with a frequency of 1Mhz, at an intensity of 1.2w/cm2 and with an application time of 10 minutes. Ischemic compression and analytical stretching of the quadratus lumborum, multifidus and iliocostalis muscles, constant pressure with the thumb on each muscular trigger point (MTrP) for between 30 s and 2 min the intensity of the pressure will be adjusted to a level at which each subject reports "comfortable pain", that is, between the pain threshold and the maximum tolerable pain

Treatment:

Procedure: conventional therapy