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

Canandaigua VA Medical Center20 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

Yoga (stretching plus mindfulness)OTHER

Stretching plus mindfulness

StretchingOTHER

Stretching alone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: baseline, immediately post intervention

Data from ClinicalTrials.gov

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