Low Back Pain, MechanicalNCT06069388
Effectiveness of Diaphragm Treatment in Reducing Low Back Pain
A study testing diaphragm technique and conventional therapy in people with Low Back Pain, Mechanical, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- diaphragm technique and conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Juan Antonio Díaz-Mancha
Seville, Seville
Juan Antonio Díaz-Mancha, PhD, +34610811169, jdm@us.es
About this study
Official title: Benefits of Diaphragm Treatment in Reducing Low Back Pain in Patients With Mechanical Lumbar Pain
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.
Read more
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
- Being tested
- diaphragm technique, conventional therapy
- Keywords
- low back pain, diaphragm, lumbar pain, physiotherapy, conventional, treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm techniqueProcedure or surgery
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 therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm technique | Experimental | 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. Receives: Procedure: diaphragm technique; Procedure: conventional therapy |
| conventional physiotherapy | Active comparator | 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 Receives: Procedure: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schober test
The Schober test measures the degree of elasticity of the spine, the coxofemoral joints or the hamstring muscles, taking into account that the overall mobility of the spine depends on all the segments that constitute it. It will be performed with the patient standing with his arms along the trunk. The therapist will stand on one side of the patient in a double feint facing towards him. With the help of a marker, the therapist makes a horizontal mark at the level of the S1 vertebra and another 10 cm above this first one. He asks the patient to lean forward and measures the distance between both marks. Next, he asks you again to extend the trunk and measures this distance again.
Measured: baseline, pre-intervention/procedure/surgery
Fingers-Floor Distance (DDS) test
This test is used to assess the elasticity of the spine. It will be performed with the patient standing with feet together and knees fully extended. The therapist will stand next to the patient in a squatting position to be able to make the resulting measurement with the help of a measuring tape. The therapist asks the patient to anteflexion the spine so that his arms, hands and fingers are fully extended and relaxed forward. In the same way, at the end of anteflexion the therapist must measure the distance between the tips of the fingers and the floor with a tape measure. If pain appears in the second part of the movement, one can think of the existence of a dysfunction of the lumbar spine or the sacroiliac joints. Likewise, if the symptoms are accentuated in the third part of anteflexion, the therapist may think of an alteration of the upper lumbar or thoracic spine.
Measured: baseline, pre-intervention/procedure/surgery
Measurement of thoracic expansion
It can be used as a method of evaluating the expansion of diaphragmatic breathing to quantify possible alterations in thoracic capacity and abdominal and chest wall compliance achieved by all expiratory and inspiratory muscles. By recording the expansion of the rib cage with a tape measure over the second intercostal space (axillary level), the xiphoid process, and the midpoint between the xiphoid process and the umbilicus (abdominal level), proficiency in diaphragmatic breathing can be demonstrated.It will be evaluated with cirtometry using a simple measuring tape, marked in centimeters, around the thorax and abdomen. With the patient standing and with their hands on their head, the patient will be asked to "inhale as much as possible" and "exhale as much as possible."
Measured: baseline, pre-intervention/procedure/surgery
Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer (quantitative v.), in the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L312. In the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L3. PPT measurements will be performed manually gradually until the patient begins to feel pain. This process will be carried out three times in the same place and within an interval of 30 to 60 s, using the average of these three measurements.
Measured: baseline, pre-intervention/procedure/surgery
Measurement of respiratory parameters through spirometry
First the subject is seated, the patient holds the spirometer horizontally in his right hand with the screen pointing upward. He puts the spirometer near his mouth and presses the operation button. You will hear a short beep. At the second beep, the subject takes in as much air as possible. Then place the mouthpiece of the spirometer in your mouth and blow as hard as you can for at least 1.5 seconds. The measurement will be repeated at least three times. One-minute intervals will be applied between these measurements to avoid fatigue of the respiratory muscles in the short term. We will measure the parameters of forced expiratory volume at one second (FEV1) and forced vital capacity (CVF).
Measured: baseline, pre-intervention/procedure/surgery
Evaluation of quality of life using the SF-12 life questionnaire. (quantitative v.)
The health-related quality of life questionnaire Short-Form 12-item (SF-12), which will be applied to determine the measure of health-related quality of life in the direct score and the optimal normalized values to evaluate the domains of physical and mental health. The evaluator will explain each of the items on the scales to the patient, and the patient will complete them in paper format in the presence of the evaluator to resolve any questions they may have. Later the evaluator will extract the scores. Scale of 12 questions in which each item of the scale evaluates different aspects on a scale from 0 (no quality of life) to 100 (highest quality of life). 100 being a result that indicates optimal health and 0 reflecting a state of very bad health.
Measured: baseline, pre-intervention/procedure/surgery
Secondary outcomes (5)
Schober test
The Schober test measures the degree of elasticity of the spine, the coxofemoral joints or the hamstring muscles, taking into account that the overall mobility of the spine depends on all the segments that constitute it. It will be performed with the patient standing with his arms along the trunk. The therapist will stand on one side of the patient in a double feint facing towards him. With the help of a marker, the therapist makes a horizontal mark at the level of the S1 vertebra and another 10 cm above this first one. He asks the patient to lean forward and measures the distance between both marks. Next, he asks you again to extend the trunk and measures this distance again.
Measured: immediately after the intervention/procedure/surgery
Fingers-Floor Distance (DDS) test
This test is used to assess the elasticity of the spine. It will be performed with the patient standing with feet together and knees fully extended. The therapist will stand next to the patient in a squatting position to be able to make the resulting measurement with the help of a measuring tape. The therapist asks the patient to anteflexion the spine so that his arms, hands and fingers are fully extended and relaxed forward. In the same way, at the end of anteflexion the therapist must measure the distance between the tips of the fingers and the floor with a tape measure. If pain appears in the second part of the movement, one can think of the existence of a dysfunction of the lumbar spine or the sacroiliac joints. Likewise, if the symptoms are accentuated in the third part of anteflexion, the therapist may think of an alteration of the upper lumbar or thoracic spine.
Measured: immediately after the intervention/procedure/surgery
Measurement of thoracic expansion
It can be used as a method of evaluating the expansion of diaphragmatic breathing to quantify possible alterations in thoracic capacity and abdominal and chest wall compliance achieved by all expiratory and inspiratory muscles. By recording the expansion of the rib cage with a tape measure over the second intercostal space (axillary level), the xiphoid process, and the midpoint between the xiphoid process and the umbilicus (abdominal level), proficiency in diaphragmatic breathing can be demonstrated.It will be evaluated with cirtometry using a simple measuring tape, marked in centimeters, around the thorax and abdomen. With the patient standing and with their hands on their head, the patient will be asked to "inhale as much as possible" and "exhale as much as possible."
Measured: immediately after the intervention/procedure/surgery
Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer (quantitative v.), in the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L312. In the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L3. PPT measurements will be performed manually gradually until the patient begins to feel pain. This process will be carried out three times in the same place and within an interval of 30 to 60 s, using the average of these three measurements.
Measured: immediately after the intervention/procedure/surgery
Measurement of respiratory parameters through spirometry
First the subject is seated, the patient holds the spirometer horizontally in his right hand with the screen pointing upward. He puts the spirometer near his mouth and presses the operation button. You will hear a short beep. At the second beep, the subject takes in as much air as possible. Then place the mouthpiece of the spirometer in your mouth and blow as hard as you can for at least 1.5 seconds. The measurement will be repeated at least three times. One-minute intervals will be applied between these measurements to avoid fatigue of the respiratory muscles in the short term. We will measure the parameters of forced expiratory volume at one second (FEV1) and forced vital capacity (CVF).
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Sep 2023
- Primary completionAug 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes María Fernández Seguín, University of Seville
- Investigators
- Juan Antonio Díaz-Mancha, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069388
- Sponsor's protocol ID
- DIAFRAGMA
- Status last verified
- May 2024
- First submitted
- 18 Sep 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Nov;248:108394. doi: 10.1016/j.rmed.2025.108394. Epub 2025 Oct 4.
PubMed 41047009
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Diaphragm Treatment in Reducing Low Back Pain in Patients With Mechanical Lumbar Pain
- ClinicalTrials.gov ID
- NCT06069388
- Acronym / sponsor ID
- DIAFRAGMA
- Conditions
- Low Back Pain, Mechanical
- Keywords
- low back pain, diaphragm, lumbar pain, physiotherapy, conventional, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm technique | Experimental | Procedure: diaphragm technique, Procedure: conventional therapyThe 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. |
| conventional physiotherapy | Active comparator | Procedure: conventional therapyApplication 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient diagnosed with subacute or chronic mechanical low back pain by a specialist doctor and who has attended in "Fisioclinic" physiotherapy clinic.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragm techniqueThe 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. | Procedure or surgery | Diaphragm technique |
| conventional therapyThe 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. | Procedure or surgery | Diaphragm technique, conventional physiotherapy |
Primary outcome
Schober test
Time frame: baseline, pre-intervention/procedure/surgery
The Schober test measures the degree of elasticity of the spine, the coxofemoral joints or the hamstring muscles, taking into account that the overall mobility of the spine depends on all the segments that constitute it. It will be performed with the patient standing with his arms along the trunk. The therapist will stand on one side of the patient in a double feint facing towards him. With the help of a marker, the therapist makes a horizontal mark at the level of the S1 vertebra and another 10 cm above this first one. He asks the patient to lean forward and measures the distance between both marks. Next, he asks you again to extend the trunk and measures this distance again.
Fingers-Floor Distance (DDS) test
Time frame: baseline, pre-intervention/procedure/surgery
This test is used to assess the elasticity of the spine. It will be performed with the patient standing with feet together and knees fully extended. The therapist will stand next to the patient in a squatting position to be able to make the resulting measurement with the help of a measuring tape. The therapist asks the patient to anteflexion the spine so that his arms, hands and fingers are fully extended and relaxed forward. In the same way, at the end of anteflexion the therapist must measure the distance between the tips of the fingers and the floor with a tape measure. If pain appears in the second part of the movement, one can think of the existence of a dysfunction of the lumbar spine or the sacroiliac joints. Likewise, if the symptoms are accentuated in the third part of anteflexion, the therapist may think of an alteration of the upper lumbar or thoracic spine.
Measurement of thoracic expansion
Time frame: baseline, pre-intervention/procedure/surgery
It can be used as a method of evaluating the expansion of diaphragmatic breathing to quantify possible alterations in thoracic capacity and abdominal and chest wall compliance achieved by all expiratory and inspiratory muscles. By recording the expansion of the rib cage with a tape measure over the second intercostal space (axillary level), the xiphoid process, and the midpoint between the xiphoid process and the umbilicus (abdominal level), proficiency in diaphragmatic breathing can be demonstrated.It will be evaluated with cirtometry using a simple measuring tape, marked in centimeters, around the thorax and abdomen. With the patient standing and with their hands on their head, the patient will be asked to "inhale as much as possible" and "exhale as much as possible."
Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
Time frame: baseline, pre-intervention/procedure/surgery
using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer (quantitative v.), in the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L312. In the center of the paravertebral spinal musculature bilaterally and perpendicular to the spinous process of L3. PPT measurements will be performed manually gradually until the patient begins to feel pain. This process will be carried out three times in the same place and within an interval of 30 to 60 s, using the average of these three measurements.
Measurement of respiratory parameters through spirometry
Time frame: baseline, pre-intervention/procedure/surgery
First the subject is seated, the patient holds the spirometer horizontally in his right hand with the screen pointing upward. He puts the spirometer near his mouth and presses the operation button. You will hear a short beep. At the second beep, the subject takes in as much air as possible. Then place the mouthpiece of the spirometer in your mouth and blow as hard as you can for at least 1.5 seconds. The measurement will be repeated at least three times. One-minute intervals will be applied between these measurements to avoid fatigue of the respiratory muscles in the short term. We will measure the parameters of forced expiratory volume at one second (FEV1) and forced vital capacity (CVF).
Evaluation of quality of life using the SF-12 life questionnaire. (quantitative v.)
Time frame: baseline, pre-intervention/procedure/surgery
The health-related quality of life questionnaire Short-Form 12-item (SF-12), which will be applied to determine the measure of health-related quality of life in the direct score and the optimal normalized values to evaluate the domains of physical and mental health. The evaluator will explain each of the items on the scales to the patient, and the patient will complete them in paper format in the presence of the evaluator to resolve any questions they may have. Later the evaluator will extract the scores. Scale of 12 questions in which each item of the scale evaluates different aspects on a scale from 0 (no quality of life) to 100 (highest quality of life). 100 being a result that indicates optimal health and 0 reflecting a state of very bad health.
5 secondary outcomes
Schober test
Time frame: immediately after the intervention/procedure/surgery
Fingers-Floor Distance (DDS) test
Time frame: immediately after the intervention/procedure/surgery
Measurement of thoracic expansion
Time frame: immediately after the intervention/procedure/surgery
Pressure pain threshold (PPT) of the five lumbar vertebrae, quadratus lumborum and lumbar paravertebral
Time frame: immediately after the intervention/procedure/surgery
Measurement of respiratory parameters through spirometry
Time frame: immediately after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41047009Vera-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 Nov;248:108394. doi: 10.1016/j.rmed.2025.108394. Epub 2025 Oct 4.
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Antonio Díaz-Mancha, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragm technique and conventional therapy in people with Low Back Pain, Mechanical, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lourdes M Fernández-Seguín, PhD (+34630258773, lfdez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schober test (time frame: baseline, pre-intervention/procedure/surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.