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

NCT03432169 | Completed

• 1 other identifier: IRBnet 1135250
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PROMIS Global Health Scale (GHS):

  baseline, immediately post intervention

• Pain, Engagement and General activity (PEG)

  baseline, immediately post intervention

Study Arms (2)

Yoga

ACTIVE COMPARATOR

Stretching with mindfulness

Other: Yoga (stretching plus mindfulness)

Stretching

ACTIVE COMPARATOR

Stretching exercises without mindfulness

Other: Stretching

Interventions

Yoga (stretching plus mindfulness) OTHER

Stretching plus mindfulness

Yoga

Stretching OTHER

Stretching alone

Stretching

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Veterans between the ages of 18-89
• Lower back pain \> 12 weeks
• Have the ability to exercise independently.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead

Study Sites (1)

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

Rochester, New York, 14620, United States

Location

MeSH Terms

Interventions

Yoga; Mindfulness

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Will code data entered into database.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Chiropractor

Model Details: Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: February 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)