Chronic Mechanical Low Back PainNCT06398249
Effect of Deep Breathing on Balance in Patients With Chronic Mechanical Low Back Pain
An observational study of Chronic Mechanical Low Back Pain, run by October 6 University at 1 site in Egypt.
Trial summary
The primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Mechanical Low Back Pain
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2024to 30 Mar 2024
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chronic low back pain patients from referrals to out patients clinics at faculty of physical therapy Cairo university. Matched healthy volunteers from students and employees of faculty of physical therapy Cairo university
Who may be able to join
- Participants in both groups should fulfill the criteria set for age and BMI ranges.
- Patients in study group should complain of pain in the lower back for a period of more than 3 months.
- Referred from an orthopedist .
- Participants in control group should haven't complained of back pain
Who cannot join
- Patients complain of radiculopathy .
- Patients complain of any other musculoskeletal disorder other than chronic mechanical low back pain .
- Any previous or current complains of pain involving other regions of the spine.
- Have history of respiratory dysfunction due to current or previous respiratory condition.
- suffer from any condition that affect balance control, including neurological, vestibular, visual or somatosensory deficits.
- use drugs that might compromise their balance control
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. Secondary to compare between dynamic balance control during deep versus regular breathing patterns in patients with chronic mechanical low back pain and healthy controls. Further, to detect whether pain intensity differs during balance testing applying either deep or regular breathing in patients with chronic mechanical low back pain.
Read the detailed description
Diaphragm has been reported as a contributor in postural control and respiration. However, the integrated function of postural control and respiration is a complex process, especially evident during activities that increase demands on one or both functions . Previous research reports noticed that breathing pattern is altered in cases of chronic mechanical low back pain during tasks that challenges the trunk muscles function, and trunk stability . Dynamic balance control is one of the functional tasks that burdens the trunk muscles, and requires high degree of integration. Dynamic balance is disturbed in cases of chronic mechanical low back pain, and reports indicate that balance deficits extends after the painful episodes in those who have history of low back pain In patients with chronic mechanical low back pain regular respiratory movements results in greater disturbances to balance than healthy subjects .
Accordingly, in this study will attempt to emphasize the role of the deep breathing pattern during dynamic balance testing in chronic mechanical low back pain patients and matched healthy control subjects. As it is suggested that activity of the diaphragm will be focused upon through introducing deep breathing during dynamic balance testing; it is expected to enhance dynamic balance through its dual integrating its dual function of postural control and respiration.
- Conditions
- Chronic Mechanical Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | chronic mechanical low back pain | |
| control | healthy matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic balance testing -
overall, mediolateral( ML), and anteroposterior(AP).
Measured: At subject enrollment "single session"
pain intensity
visual analogue scale. A 10 cm horizontal line with one end denote "no pain" and the other end denote "severe intractable pain
Measured: At subject enrollment "single session"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start2 Feb 2024
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mechanical 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Afify, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398249
- Sponsor's protocol ID
- P.T.REC/012/005061
- Status last verified
- Oct 2024
- First submitted
- 16 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Breathing on Balance in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06398249
- Acronym / sponsor ID
- P.T.REC/012/005061
- Conditions
- Chronic Mechanical Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 3 May 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.
The primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. Secondary to compare between dynamic balance control during deep versus regular breathing patterns in patients with chronic mechanical low back pain and healthy controls. Further, to detect whether pain intensity differs during balance testing applying either deep or regular breathing in patients with chronic mechanical low back pain.
Detailed description
Diaphragm has been reported as a contributor in postural control and respiration. However, the integrated function of postural control and respiration is a complex process, especially evident during activities that increase demands on one or both functions . Previous research reports noticed that breathing pattern is altered in cases of chronic mechanical low back pain during tasks that challenges the trunk muscles function, and trunk stability . Dynamic balance control is one of the functional tasks that burdens the trunk muscles, and requires high degree of integration. Dynamic balance is disturbed in cases of chronic mechanical low back pain, and reports indicate that balance deficits extends after the painful episodes in those who have history of low back pain In patients with chronic mechanical low back pain regular respiratory movements results in greater disturbances to balance than healthy subjects .
Accordingly, in this study will attempt to emphasize the role of the deep breathing pattern during dynamic balance testing in chronic mechanical low back pain patients and matched healthy control subjects. As it is suggested that activity of the diaphragm will be focused upon through introducing deep breathing during dynamic balance testing; it is expected to enhance dynamic balance through its dual integrating its dual function of postural control and respiration.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | –chronic mechanical low back pain |
| control | – | –healthy matched controls |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chronic low back pain patients from referrals to out patients clinics at faculty of physical therapy Cairo university. Matched healthy volunteers from students and employees of faculty of physical therapy Cairo university
Key inclusion criteria (4 listed)
- Participants in both groups should fulfill the criteria set for age and BMI ranges.
- Patients in study group should complain of pain in the lower back for a period of more than 3 months.
- Referred from an orthopedist .
- Participants in control group should haven't complained of back pain
Key exclusion criteria (6 listed)
- Patients complain of radiculopathy .
- Patients complain of any other musculoskeletal disorder other than chronic mechanical low back pain .
- Any previous or current complains of pain involving other regions of the spine.
- Have history of respiratory dysfunction due to current or previous respiratory condition.
- suffer from any condition that affect balance control, including neurological, vestibular, visual or somatosensory deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dynamic balance testing -
Time frame: At subject enrollment "single session"
overall, mediolateral( ML), and anteroposterior(AP).
pain intensity
Time frame: At subject enrollment "single session"
visual analogue scale. A 10 cm horizontal line with one end denote "no pain" and the other end denote "severe intractable pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Mechanical Low Back Pain, run by October 6 University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 15 Oct 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic balance testing - (time frame: At subject enrollment "single session"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.