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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga (stretching plus mindfulness)
Stretching
Sponsored by
Canandaigua VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Yoga

Stretching

Arm Description

Stretching with mindfulness

Stretching exercises without mindfulness

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 1, 2018
Last Updated
October 9, 2019
Sponsor
Canandaigua VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03432169
Brief Title
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Official Title
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canandaigua VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
Masking
Outcomes Assessor
Masking Description
Will code data entered into database.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Active Comparator
Arm Description
Stretching with mindfulness
Arm Title
Stretching
Arm Type
Active Comparator
Arm Description
Stretching exercises without mindfulness
Intervention Type
Other
Intervention Name(s)
Yoga (stretching plus mindfulness)
Intervention Description
Stretching plus mindfulness
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Stretching alone
Primary Outcome Measure Information:
Title
Feasibility
Description
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 Outcome Measure Information:
Title
PROMIS Global Health Scale (GHS):
Description
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
Title
Pain, Engagement and General activity (PEG)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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