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

• ClinicalTrials.gov Identifier: NCT03432169
• Recruitment Status: Completed
• First Posted: February 14, 2018
• Last Update Posted: October 10, 2019
• Sponsor: Canandaigua VA Medical Center
• Information provided by (Responsible Party): Paul Dougherty, DC, Canandaigua VA Medical Center

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Other: Yoga (stretching plus mindfulness); Other: Stretching	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
• Masking: Single (Outcomes Assessor)
• Masking Description: Will code data entered into database.
• Primary Purpose: Other
• Official Title: Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Yoga; Stretching with mindfulness	Other: Yoga (stretching plus mindfulness); Stretching plus mindfulness
Active Comparator: Stretching; Stretching exercises without mindfulness	Other: Stretching; Stretching alone

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. PROMIS Global Health Scale (GHS): [ Time Frame: baseline, immediately post intervention ]
   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.
2. Pain, Engagement and General activity (PEG) [ Time Frame: baseline, immediately post intervention ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

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

Rochester, New York, United States, 14620

Sponsors and Collaborators

Canandaigua VA Medical Center

More Information

• Responsible Party: Paul Dougherty, DC, Staff Chiropractor, Canandaigua VA Medical Center
• ClinicalTrials.gov Identifier: NCT03432169
• Other Study ID Numbers: IRBnet 1135250
• First Posted: February 14, 2018
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations