Skip to main content
Clinical Trials/NCT03432169
NCT03432169
Completed
Not Applicable

Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?

Canandaigua VA Medical Center1 site in 1 country20 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Canandaigua VA Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Feasibility
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)

Detailed Description

The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Canandaigua VA Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Paul Dougherty, DC

Staff Chiropractor

Canandaigua VA Medical Center

Eligibility Criteria

Inclusion Criteria

  • Adult Veterans between the ages of 18-89
  • Lower back pain \> 12 weeks
  • Have the ability to exercise independently.

Exclusion Criteria

  • Subjects will be excluded if
  • They are currently enrolled in or maintain a home meditation practice
  • If they are currently involved in a mindfulness or cognitive behavioral therapy group.
  • If they have participated in a structured group yoga class in the last three months.
  • If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.

Outcomes

Primary Outcomes

Feasibility

Time Frame: 6 months

The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.

Secondary Outcomes

  • PROMIS Global Health Scale (GHS):(baseline, immediately post intervention)
  • Pain, Engagement and General activity (PEG)(baseline, immediately post intervention)

Study Sites (1)

Loading locations...

Similar Trials