Nonspecific Low Back PainNCT06375018
Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain
A study testing Diaphragm Stretching in people with Nonspecific Low Back Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonspecific Low Back Pain
- What is being tested?
- Diaphragm Stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2024to Dec 2025
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonspecific low back pain;
- Age between 18 and 30.
Who cannot join
- Serious cardiovascular and cardiorespiratory causes;
- Spinal pathologies and injuries to the lumbar spine;
- Cancer patients;
- Pacemaker or implant carriers;
- Pregnant women or volunteers suspected of being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Diaphragm Stretching Technique on Symptomatology in Young Adults With Nonspecific Low Back Pain: Randomized Controlled Trial
This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain.
Read the detailed description
Nonspecific low back pain occurs when there is an imbalance in the lower back between functional load and the ability to perform daily tasks. It is characterized as such when there is no specific and well-determined diagnosis and there are no structural changes.
The diaphragm and abdominal muscles together create a hydraulic effect in the abdominal cavity, which helps stabilize the spine, providing rigidity to the lumbar spine by increasing intra-abdominal pressure. Diaphragmatic changes in patients diagnosed with low back pain may contribute to the lack of spinal control activity through several mechanisms. Thus, it is concluded that the diaphragm is anatomically related to the lumbar spine, through its muscle fibers.
There are articles that relate the topic of low back pain with Osteopathic Manual Treatment, demonstrating that, despite this lack of scientific evidence, the results obtained at a clinical level are favorable.
This study aims to evaluate the effectiveness of diaphragm stretching techniques on symptoms experienced by young adults with non-specific low back pain.
In this study, the investigators will analyze the effects of the diaphragm stretching technique on the following variables: the sniff nasal inspiratory pressure test (SNIP test) , Visual Analogue Scale (VAS) score, the Schober test and measurement of the distance between the fingers and the ground during anterior flexion of the trunk, without flexion of the lower limbs (also known as the Finger Tip Test).
- Conditions
- Nonspecific Low Back Pain
- Being tested
- Placebo Technique, Diaphragm Stretching
- Keywords
- Diaphragm, Low Back Pain, Osteopathy, Osteopathic Medicine, Stretching Technique, Young Adults
- 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.
Placebo TechniqueOther
In the control group, manual contact will be carried out without any therapeutic intention. This contact will be maintained for the same period of time as the experimental group.
Diaphragm StretchingOther
The participant will be in supine position and the researcher will be at the headrest of the examination table, placing his hands on the lower costal margin. Superior direction traction is performed during inspiration, remaining during expiration. The procedure is repeated for a maximum period of 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | After data collection, each volunteer will undergo a simulated technique within this group. The investigator will mimic the contacts of the phrenic nerve inhibition technique without applying traction or compression to the tissue, merely maintaining the contacts for the same duration as described in the technique performed in the experimental group, along with the same rest period afterward. Subsequently, new data will be collected following the simulated intervention. Receives: Other: Placebo Technique |
| Experimental group | Experimental | After collecting data from each volunteer, a Diaphragm Stretching technique will be administered to individuals in this group. The technique will be executed for a maximum duration of 4 minutes. Following the technique, volunteers will be required to rest for 5 minutes. Subsequently, another round of data collection will be conducted. Receives: Other: Diaphragm Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of inspiratory capacity immediately after intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the respiratory pressure meter.
Measured: Immediately after the intervention
Change in the level of disability derived from low back pain immediately after the intervention
Assessment instruments to evaluate the degree of disability resulting from low back pain include the Visual Analogue Scale. In this scale, a higher score indicates a greater level of pain, correlating with a worse outcome. Conversely, a lower score indicates less pain, corresponding to a better outcome.
Measured: Immediately after the intervention
Change in the level of functionality of the lumbar spine immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the Schober test.
Measured: Immediately after the intervention
Change in the level of functionality of the lumbar spine immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the measurement of the distance from the hands to the floor after forward flexion of the trunk while standing with knee extension (also known as the Finger Tip Test).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Nonspecific Low Back PainStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375018
- Sponsor's protocol ID
- OST1_011
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.
PubMed 16023475Hodges PW, Heijnen I, Gandevia SC. Postural activity of the diaphragm is reduced in humans when respiratory demand increases. J Physiol. 2001 Dec 15;537(Pt 3):999-1008. doi: 10.1111/j.1469-7793.2001.00999.x.
PubMed 11744772Bains KNS, Kashyap S, Lappin SL. Anatomy, Thorax: Diaphragm. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519558/
PubMed 30137842Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. In vivo measurement of the effect of intra-abdominal pressure on the human spine. J Biomech. 2001 Mar;34(3):347-53. doi: 10.1016/s0021-9290(00)00206-2.
PubMed 11182126Fernandez-Lopez I, Pena-Otero D, Atin-Arratibel MLA, Eguillor-Mutiloa M. Effects of Manual Therapy on the Diaphragm in the Musculoskeletal System: A Systematic Review. Arch Phys Med Rehabil. 2021 Dec;102(12):2402-2415. doi: 10.1016/j.apmr.2021.03.031. Epub 2021 Apr 29.
PubMed 33932362Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
PubMed 30568484Fitting JW. Sniff nasal inspiratory pressure: simple or too simple? Eur Respir J. 2006 May;27(5):881-3. doi: 10.1183/09031936.06.00007906. No abstract available.
PubMed 16707389Grimstone SK, Hodges PW. Impaired postural compensation for respiration in people with recurrent low back pain. Exp Brain Res. 2003 Jul;151(2):218-24. doi: 10.1007/s00221-003-1433-5. Epub 2003 May 21.
PubMed 12759796Heritier F, Rahm F, Pasche P, Fitting JW. Sniff nasal inspiratory pressure. A noninvasive assessment of inspiratory muscle strength. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 1):1678-83. doi: 10.1164/ajrccm.150.6.7952632.
PubMed 7952632Hershkovich O, Grevitt MP, Lotan R. Schober Test and Its Modifications Revisited-What Are We Actually Measuring? Computerized Tomography-Based Analysis. J Clin Med. 2022 Nov 22;11(23):6895. doi: 10.3390/jcm11236895.
PubMed 36498470Heuch I, Hagen K, Heuch I, Nygaard O, Zwart JA. The impact of body mass index on the prevalence of low back pain: the HUNT study. Spine (Phila Pa 1976). 2010 Apr 1;35(7):764-8. doi: 10.1097/BRS.0b013e3181ba1531.
PubMed 20228714Hides J, Gilmore C, Stanton W, Bohlscheid E. Multifidus size and symmetry among chronic LBP and healthy asymptomatic subjects. Man Ther. 2008 Feb;13(1):43-9. doi: 10.1016/j.math.2006.07.017. Epub 2006 Oct 27.
PubMed 17070721Hodges PW, Gandevia SC. Activation of the human diaphragm during a repetitive postural task. J Physiol. 2000 Jan 1;522 Pt 1(Pt 1):165-75. doi: 10.1111/j.1469-7793.2000.t01-1-00165.xm.
PubMed 10618161Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.
PubMed 10956340Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. Three dimensional preparatory trunk motion precedes asymmetrical upper limb movement. Gait Posture. 2000 Apr;11(2):92-101. doi: 10.1016/s0966-6362(99)00055-7.
PubMed 10899662
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Diaphragm Stretching Technique on Symptomatology in Young Adults With Nonspecific Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06375018
- Acronym / sponsor ID
- OST1_011
- Conditions
- Nonspecific Low Back Pain
- Keywords
- Diaphragm, Low Back Pain, Osteopathy, Osteopathic Medicine, Stretching Technique, Young Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (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.
This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain.
Detailed description
Nonspecific low back pain occurs when there is an imbalance in the lower back between functional load and the ability to perform daily tasks. It is characterized as such when there is no specific and well-determined diagnosis and there are no structural changes.
The diaphragm and abdominal muscles together create a hydraulic effect in the abdominal cavity, which helps stabilize the spine, providing rigidity to the lumbar spine by increasing intra-abdominal pressure. Diaphragmatic changes in patients diagnosed with low back pain may contribute to the lack of spinal control activity through several mechanisms. Thus, it is concluded that the diaphragm is anatomically related to the lumbar spine, through its muscle fibers.
There are articles that relate the topic of low back pain with Osteopathic Manual Treatment, demonstrating that, despite this lack of scientific evidence, the results obtained at a clinical level are favorable.
This study aims to evaluate the effectiveness of diaphragm stretching techniques on symptoms experienced by young adults with non-specific low back pain.
In this study, the investigators will analyze the effects of the diaphragm stretching technique on the following variables: the sniff nasal inspiratory pressure test (SNIP test) , Visual Analogue Scale (VAS) score, the Schober test and measurement of the distance between the fingers and the ground during anterior flexion of the trunk, without flexion of the lower limbs (also known as the Finger Tip Test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Placebo TechniqueAfter data collection, each volunteer will undergo a simulated technique within this group. The investigator will mimic the contacts of the phrenic nerve inhibition technique without applying traction or compression to the tissue, merely maintaining the contacts for the same duration as described in the technique performed in the experimental group, along with the same rest period afterward. Subsequently, new data will be collected following the simulated intervention. |
| Experimental group | Experimental | Other: Diaphragm StretchingAfter collecting data from each volunteer, a Diaphragm Stretching technique will be administered to individuals in this group. The technique will be executed for a maximum duration of 4 minutes. Following the technique, volunteers will be required to rest for 5 minutes. Subsequently, another round of data collection will be conducted. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonspecific low back pain;
- Age between 18 and 30.
Key exclusion criteria (5 listed)
- Serious cardiovascular and cardiorespiratory causes;
- Spinal pathologies and injuries to the lumbar spine;
- Cancer patients;
- Pacemaker or implant carriers;
- Pregnant women or volunteers suspected of being pregnant.
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 |
|---|---|---|
| Placebo TechniqueIn the control group, manual contact will be carried out without any therapeutic intention. This contact will be maintained for the same period of time as the experimental group. | Other | Control group |
| Diaphragm StretchingThe participant will be in supine position and the researcher will be at the headrest of the examination table, placing his hands on the lower costal margin. Superior direction traction is performed during inspiration, remaining during expiration. The procedure is repeated for a maximum period of 4 minutes. | Other | Experimental group |
Primary outcome
Change in level of inspiratory capacity immediately after intervention
Time frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the respiratory pressure meter.
Change in the level of disability derived from low back pain immediately after the intervention
Time frame: Immediately after the intervention
Assessment instruments to evaluate the degree of disability resulting from low back pain include the Visual Analogue Scale. In this scale, a higher score indicates a greater level of pain, correlating with a worse outcome. Conversely, a lower score indicates less pain, corresponding to a better outcome.
Change in the level of functionality of the lumbar spine immediately after the intervention
Time frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the Schober test.
Change in the level of functionality of the lumbar spine immediately after the intervention
Time frame: Immediately after the intervention
Assessment instruments to assess the degree of disability resulting from low back pain include the measurement of the distance from the hands to the floor after forward flexion of the trunk while standing with knee extension (also known as the Finger Tip Test).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 16023475Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.
- Background: PubMed 11744772Hodges PW, Heijnen I, Gandevia SC. Postural activity of the diaphragm is reduced in humans when respiratory demand increases. J Physiol. 2001 Dec 15;537(Pt 3):999-1008. doi: 10.1111/j.1469-7793.2001.00999.x.
- Background: PubMed 30137842Bains KNS, Kashyap S, Lappin SL. Anatomy, Thorax: Diaphragm. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519558/
- Background: PubMed 11182126Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. In vivo measurement of the effect of intra-abdominal pressure on the human spine. J Biomech. 2001 Mar;34(3):347-53. doi: 10.1016/s0021-9290(00)00206-2.
- Background: PubMed 33932362Fernandez-Lopez I, Pena-Otero D, Atin-Arratibel MLA, Eguillor-Mutiloa M. Effects of Manual Therapy on the Diaphragm in the Musculoskeletal System: A Systematic Review. Arch Phys Med Rehabil. 2021 Dec;102(12):2402-2415. doi: 10.1016/j.apmr.2021.03.031. Epub 2021 Apr 29.
- Background: PubMed 30568484Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
- Background: PubMed 16707389Fitting JW. Sniff nasal inspiratory pressure: simple or too simple? Eur Respir J. 2006 May;27(5):881-3. doi: 10.1183/09031936.06.00007906. No abstract available.
- Background: PubMed 12759796Grimstone SK, Hodges PW. Impaired postural compensation for respiration in people with recurrent low back pain. Exp Brain Res. 2003 Jul;151(2):218-24. doi: 10.1007/s00221-003-1433-5. Epub 2003 May 21.
- Background: PubMed 7952632Heritier F, Rahm F, Pasche P, Fitting JW. Sniff nasal inspiratory pressure. A noninvasive assessment of inspiratory muscle strength. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 1):1678-83. doi: 10.1164/ajrccm.150.6.7952632.
- Background: PubMed 36498470Hershkovich O, Grevitt MP, Lotan R. Schober Test and Its Modifications Revisited-What Are We Actually Measuring? Computerized Tomography-Based Analysis. J Clin Med. 2022 Nov 22;11(23):6895. doi: 10.3390/jcm11236895.
- Background: PubMed 20228714Heuch I, Hagen K, Heuch I, Nygaard O, Zwart JA. The impact of body mass index on the prevalence of low back pain: the HUNT study. Spine (Phila Pa 1976). 2010 Apr 1;35(7):764-8. doi: 10.1097/BRS.0b013e3181ba1531.
- Background: PubMed 17070721Hides J, Gilmore C, Stanton W, Bohlscheid E. Multifidus size and symmetry among chronic LBP and healthy asymptomatic subjects. Man Ther. 2008 Feb;13(1):43-9. doi: 10.1016/j.math.2006.07.017. Epub 2006 Oct 27.
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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.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Porto
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 Stretching in people with Nonspecific Low Back Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 2 inclusion and 5 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 5 Sep 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 Portugal. 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. Some participants in this study may receive a placebo. 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 Natália MO Campelo, PhD (+35122 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of inspiratory capacity immediately after intervention (time frame: Immediately after the intervention). The study lists 4 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 NCT06375018, which also lists 50 linked publications.
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 5 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.