Chronic Low Back PainEB-PainNCT03353142
The Effects Of Equal Breathing On Pain Pressure Thresholds
A study testing Equal Breathing in people with Chronic Low Back Pain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Recent research has found that there is moderate evidence for the use of breathing exercises for treating chronic, non-specific low back pain. Researchers have found that there were significant improvements in pain and quality of life in those suffering with low back pain who completed a breathing program… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Equal Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 1 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18
- Chronic low back pain
- OHIP patient
Who cannot join
- Peripheral pain
- Peripheral neuropathy
- Chronic regional pain syndrome
- Alpha and Beta blocker medication use
- Patient does not wish to participate
- Completed or participated in a psychoeducational program at the clinic
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
Hamilton, Ontario, L8N3Z5
Lisa Patterson, B.A., 905-521-2100 ext. 74279, pattersl@hhsc.ca
About this study
Official title: The Effects Of Equal Breathing On Pain Pressure Thresholds In Individuals With Chronic Low Back Pain: A Pilot Study
Recent research has found that there is moderate evidence for the use of breathing exercises for treating chronic, non-specific low back pain. Researchers have found that there were significant improvements in pain and quality of life in those suffering with low back pain who completed a breathing program intervention. Researchers also found that healthy individuals had higher pain thresholds and tolerance following deep and slow breathing exercises.
There are numerous formats of breathing interventions, some interventions that have been used with individuals with chronic, non-specific low back pain include: deep breathing, yoga breathing, resisted inspiration, and breathe holding. There is moderate evidence to suggest the use of these interventions for managing chronic low back pain Another common breathing format is Equal-Ratio Breathing. This format requires an individual to inhale and exhale with the same duration while gradually increasing the duration of both. This breathing format can be easier for patients to perform given the simplicity of the equal inhalation to exhalation ratio.
This research is being done because Equal-Ratio Breathing has yet to be studied in individuals with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Equal Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equal BreathingOther
- Blood pressure recorded at baseline, immediately pre- and post-trial
- Maximum Tolerable Breathing Ratio: Test run to determine the maximum tolerable time for inhalation and exhalation.
- PRESSURE TOLERANCE: Pressure algometer device used to determine pain pressure tolerance. It will be applied to the first dorsal interosseous and deltoid, and pain pressure tolerance will be measured and recorded. Pressure will be applied at 1kg per second until the patient indicates that the pressure has become painful. Pain pressure tolerance will be performed 3 times at each anatomical location and an average will be determined for each location.
- TRIAL: Participants will begin 5 minutes of Equal Breathing at their maximum tolerable equal breathing ratio that was previously determined. Immediately after 5 minutes of breathing, the pain pressure tolerance will be measured using pressure algometry
| Study group | Role | What they receive |
|---|---|---|
| Equal Breathing | Experimental | Not described Receives: Other: Equal Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain pressure threshold
Measured using the pressure algometer device
Measured: Pre-visit and Post-visit - same day
Secondary outcomes (2)
Difference in heart rate
Measure by pulse oximeter
Measured: Pre-visit and Post-visit - same day
Difference in blood pressure values
Measure by pulse oximeter
Measured: Pre-visit and Post-visit - same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Feb 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive participants meeting eligibility criteria will be enrolled
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurpreet Palak, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353142
- Sponsor's protocol ID
- MGD-004-20171016
- Acronym
- EB-Pain
- Status last verified
- Jun 2018
- First submitted
- 6 Nov 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Equal Breathing On Pain Pressure Thresholds In Individuals With Chronic Low Back Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT03353142
- Acronym / sponsor ID
- EB-Pain / MGD-004-20171016
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 27 Nov 2017 (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.
Recent research has found that there is moderate evidence for the use of breathing exercises for treating chronic, non-specific low back pain. Researchers have found that there were significant improvements in pain and quality of life in those suffering with low back pain who completed a breathing program intervention. Researchers also found that healthy individuals had higher pain thresholds and tolerance following deep and slow breathing exercises.
There are numerous formats of breathing interventions, some interventions that have been used with individuals with chronic, non-specific low back pain include: deep breathing, yoga breathing, resisted inspiration, and breathe holding. There is moderate evidence to suggest the use of these interventions for managing chronic low back pain Another common breathing format is Equal-Ratio Breathing. This format requires an individual to inhale and exhale with the same duration while gradually increasing the duration of both. This breathing format can be easier for patients to perform given the simplicity of the equal inhalation to exhalation ratio.
This research is being done because Equal-Ratio Breathing has yet to be studied in individuals with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive participants meeting eligibility criteria will be enrolled
| Arm | Type | Receives |
|---|---|---|
| Equal Breathing | Experimental | Other: Equal Breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18
- Chronic low back pain
- OHIP patient
Key exclusion criteria (6 listed)
- Peripheral pain
- Peripheral neuropathy
- Chronic regional pain syndrome
- Alpha and Beta blocker medication use
- Patient does not wish to participate
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 |
|---|---|---|
| Equal Breathing* Blood pressure recorded at baseline, immediately pre- and post-trial * Maximum Tolerable Breathing Ratio: Test run to determine the maximum tolerable time for inhalation and exhalation. * PRESSURE TOLERANCE: Pressure algometer device used to determine pain pressure tolerance. It will be applied to the first dorsal interosseous and deltoid, and pain pressure tolerance will be measured and recorded. Pressure will be applied at 1kg per second until the patient indicates that the pressure has become painful. Pain pressure tolerance will be performed 3 times at each anatomical location and an average will be determined for each location. * TRIAL: Participants will begin 5 minutes of Equal Breathing at their maximum tolerable equal breathing ratio that was previously determined. Immediately after 5 minutes of breathing, the pain pressure tolerance will be measured using pressure algometry | Other | Equal Breathing |
Primary outcome
Difference in pain pressure threshold
Time frame: Pre-visit and Post-visit - same day
Measured using the pressure algometer device
2 secondary outcomes
Difference in heart rate
Time frame: Pre-visit and Post-visit - same day
Difference in blood pressure values
Time frame: Pre-visit and Post-visit - same day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Chronic Low Back Pain
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
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equal Breathing in people with Chronic Low Back Pain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2018. 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 Canada. 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 Gurpreet Palak (905-521-2100, gurpreet.palak@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain pressure threshold (time frame: Pre-visit and Post-visit - same day). 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 14 Jun 2018.