The Effects Of Equal Breathing On Pain Pressure Thresholds (EB-Pain)
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Equal Breathing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Michael G. DeGroote Pain Clinic, Hamilton Health SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Equal Breathing
Arm Description
Outcomes
Primary Outcome Measures
Difference in pain pressure threshold
Measured using the pressure algometer device
Secondary Outcome Measures
Difference in heart rate
Measure by pulse oximeter
Difference in blood pressure values
Measure by pulse oximeter
Full Information
NCT ID
NCT03353142
First Posted
November 6, 2017
Last Updated
June 12, 2018
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03353142
Brief Title
The Effects Of Equal Breathing On Pain Pressure Thresholds
Acronym
EB-Pain
Official Title
The Effects Of Equal Breathing On Pain Pressure Thresholds In Individuals With Chronic Low Back Pain: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutive participants meeting eligibility criteria will be enrolled
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Equal Breathing
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Equal Breathing
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in pain pressure threshold
Description
Measured using the pressure algometer device
Time Frame
Pre-visit and Post-visit - same day
Secondary Outcome Measure Information:
Title
Difference in heart rate
Description
Measure by pulse oximeter
Time Frame
Pre-visit and Post-visit - same day
Title
Difference in blood pressure values
Description
Measure by pulse oximeter
Time Frame
Pre-visit and Post-visit - same day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gurpreet Palak
Phone
905-521-2100
Email
gurpreet.palak@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Patterson, BA
Phone
905-521-2100
Ext
74279
Email
pattersl@hhsc.ca
Facility Information:
Facility Name
Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Patterson, B.A.
Phone
905-521-2100
Ext
74279
Email
pattersl@hhsc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share IPD
Learn more about this trial
The Effects Of Equal Breathing On Pain Pressure Thresholds
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