- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432169
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
October 9, 2019 updated by: Paul Dougherty, DC, Canandaigua VA Medical Center
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Yoga
Stretching with mindfulness
|
Stretching plus mindfulness
|
Active Comparator: Stretching
Stretching exercises without mindfulness
|
Stretching alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, immediately post intervention
|
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.
|
baseline, immediately post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 14, 2018
Study Record Updates
Last Update Posted (Actual)
October 10, 2019
Last Update Submitted That Met QC Criteria
October 9, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBnet 1135250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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