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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03353142
Other study ID # MGD-004-20171016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date February 1, 2019

Study information

Verified date June 2018
Source Hamilton Health Sciences Corporation
Contact Gurpreet Palak
Phone 905-521-2100
Email gurpreet.palak@medportal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Aged = 18

- Chronic low back pain

- OHIP patient

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Canada Michael G. DeGroote Pain Clinic, Hamilton Health Sciences Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in pain pressure threshold Measured using the pressure algometer device Pre-visit and Post-visit - same day
Secondary Difference in heart rate Measure by pulse oximeter Pre-visit and Post-visit - same day
Secondary Difference in blood pressure values Measure by pulse oximeter Pre-visit and Post-visit - same day
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