NCT03353142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

November 6, 2017

Last Update Submit

June 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in pain pressure threshold

    Measured using the pressure algometer device

    Pre-visit and Post-visit - same day

Secondary Outcomes (2)

  • Difference in heart rate

    Pre-visit and Post-visit - same day

  • Difference in blood pressure values

    Pre-visit and Post-visit - same day

Study Arms (1)

Equal Breathing

EXPERIMENTAL
Other: Equal Breathing

Interventions

* 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

Equal Breathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥ 18
  • Chronic low back pain
  • OHIP patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael G. DeGroote Pain Clinic, Hamilton Health Sciences

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

Central Study Contacts

Lisa Patterson, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Consecutive participants meeting eligibility criteria will be enrolled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician - Fellow

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 27, 2017

Study Start

February 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

no plan to share IPD

Locations