Clinical trial NCT03432169: Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Official title: Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2018-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: PROMIS Global Health Scale (GHS):
timeFrame: baseline, immediately post intervention
measure: Pain, Engagement and General activity (PEG)
timeFrame: baseline, immediately post intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
state: New York
Study officials:
References: