Effectiveness of Diaphragm Treatment in Reducing Low Back Pain

NCT ID: NCT06069388

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-11-30

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.

Conditions

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diaphragm technique

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.

Group Type: EXPERIMENTAL

diaphragm technique

Intervention Type: PROCEDURE

The patient will be placed in a supine position with knees bent on a cushion. The therapist will position himself oriented from the patient's head towards his feet. The therapist will make contact with the ulnar edge of his hands on the lower edge of the last ribs. It will be pulled cephalad during the inspiratory time, opening the rib cage laterally. Traction will be maintained during expiratory time and repeated during a cycle of 10 breaths.

conventional therapy

Intervention Type: PROCEDURE

The patient will be placed in a supine position with knees bent on a cushion. The therapist will position himself oriented from the patient's head towards his feet. The therapist will make contact with the ulnar edge of his hands on the lower edge of the last ribs. It will be pulled cephalad during the inspiratory time, opening the rib cage laterally. Traction will be maintained during expiratory time and repeated during a cycle of 10 breaths.

conventional physiotherapy

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

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: PROCEDURE

The patient will be placed in a supine position with knees bent on a cushion. The therapist will position himself oriented from the patient's head towards his feet. The therapist will make contact with the ulnar edge of his hands on the lower edge of the last ribs. It will be pulled cephalad during the inspiratory time, opening the rib cage laterally. Traction will be maintained during expiratory time and repeated during a cycle of 10 breaths.

Interventions

diaphragm technique

The patient will be placed in a supine position with knees bent on a cushion. The therapist will position himself oriented from the patient's head towards his feet. The therapist will make contact with the ulnar edge of his hands on the lower edge of the last ribs. It will be pulled cephalad during the inspiratory time, opening the rib cage laterally. Traction will be maintained during expiratory time and repeated during a cycle of 10 breaths.

Intervention Type: PROCEDURE

conventional therapy

The patient will be placed in a supine position with knees bent on a cushion. The therapist will position himself oriented from the patient's head towards his feet. The therapist will make contact with the ulnar edge of his hands on the lower edge of the last ribs. It will be pulled cephalad during the inspiratory time, opening the rib cage laterally. Traction will be maintained during expiratory time and repeated during a cycle of 10 breaths.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Lourdes María Fernández Seguín

Assistant Professor. Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Antonio Díaz-Mancha, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Juan Antonio Díaz-Mancha

Seville, Seville, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Lourdes M Fernández-Seguín, PhD

Role: CONTACT

lfdez@us.es

+34630258773

Juan Antonio Díaz-Mancha, PhD

Role: CONTACT

jdm@us.es

+34610811169

Facility Contacts

Juan Antonio Díaz-Mancha, PhD

Role: primary

jdm@us.es

+34610811169

References

Vera-Serrano FJ, Vinolo-Gil MJ, Fernandez Seguin LM, Diaz-Mancha JA. EFFECTS OF DIAPHRAGMATIC MANUAL THERAPY ON RESPIRATORY FUNCTION IN PATIENTS WITH NON-SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROL TRIAL. Respir Med. 2025 Oct 3:108394. doi: 10.1016/j.rmed.2025.108394. Online ahead of print.

Reference Type: DERIVED

PMID: 41047009 (View on PubMed)

Other Identifiers

DIAFRAGMA

Identifier Type: -

Identifier Source: org_study_id