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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Yoga (stretching plus mindfulness)
* Other: Stretching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yoga<br>Stretching with mindfulness | Other: Yoga (stretching plus mindfulness)<br>* Stretching plus mindfulness<br>|
| Active Comparator: Stretching<br>Stretching exercises without mindfulness | Other: Stretching<br>* Stretching alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Global Health Scale (GHS): | Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. This form has recently been validated in comparison to the EuroQual. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. | baseline, immediately post intervention | 
| Pain, Engagement and General activity (PEG) | An ultra-brief three-item scale derived from the Brief Pain Inventory (BPI), was a reliable and valid measure of pain among primary care patients with chronic musculoskeletal pain and diverse VA ambulatory patients. | baseline, immediately post intervention |