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

NCT ID: NCT03432169

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Yoga

Stretching with mindfulness

Group Type: ACTIVE_COMPARATOR

Yoga (stretching plus mindfulness)

Intervention Type: OTHER

Stretching plus mindfulness

Stretching

Stretching exercises without mindfulness

Group Type: ACTIVE_COMPARATOR

Stretching

Intervention Type: OTHER

Stretching alone

Interventions

Yoga (stretching plus mindfulness)

Stretching plus mindfulness

Intervention Type: OTHER

Stretching

Stretching alone

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canandaigua VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Paul Dougherty, DC

Staff Chiropractor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rochester, New York, United States

Countries

United States

Other Identifiers

IRBnet 1135250

Identifier Type: -

Identifier Source: org_study_id