Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Diego, California 92161


Purpose:

Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.


Criteria:

Inclusion Criteria: - Has a VA primary care provider - Diagnosis of chronic low back pain > 6 months - Willing to attend a yoga program or be assigned to delayed treatment with yoga - Willing to complete 4 assessments - English Literacy - Has not begun new pain treatments or medications in the past month - Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary Exclusion Criteria: - back surgery within the last 12 months - back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia) - morbid obesity (BMI > 40) - Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months - Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia) - Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence) - Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves) - Attended or practiced yoga > 1x in the last 12 months - Positive Romberg test (with or without sensory neuropathy)


Study is Available At:


Original ID:

O7768-R


NCT ID:

NCT02524158


Secondary ID:


Study Acronym:


Brief Title:

Yoga for Veterans With CLBP


Official Title:

Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

152


Enrollment Type:

Actual


Overall Contact Information

Official Name:Erik J Groessl, PhD BA BS
Principal Investigator
VA San Diego Healthcare System, San Diego, CA

Study Dates

Start Date:April 2013
Completion Date:December 31, 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 11, 2018
First Received Date:August 10, 2015
First Results Date:May 10, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Time in seconds holding plank position on the elbows.
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts o
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Grip Strength at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent proced
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Range of Motion - Flexion at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward
Outcome Type:Secondary Outcome
Measure:Attendance/ Home Practice
Time Frame:12 weeks
Safety Issues:False
Description:Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga.
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a sca
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never)
Outcome Type:Secondary Outcome
Measure:Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.
Outcome Type:Secondary Outcome
Measure:Change From Baseline - SF12 MCS at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health stat
Outcome Type:Secondary Outcome
Measure:Change From Baseline - SF12 PCS at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were sel
Outcome Type:Secondary Outcome
Measure:Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on dai
Outcome Type:Secondary Outcome
Measure:Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
Time Frame:baseline to 6 months
Safety Issues:False
Description:The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated
Outcome Type:Primary Outcome
Measure:Roland-Morris Disability Questionnaire
Time Frame:baseline to 6-months
Safety Issues:False
Description:The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety
Outcome Type:Primary Outcome
Measure:Roland-Morris Disability Questionnaire
Time Frame:baseline to 12 weeks
Safety Issues:False
Description:The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily

Study Interventions

Intervention Type:Behavioral
Name:Yoga Therapy for CLBP
Description:Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be
Arm Name:Yoga

Study Arms

Study Arm Type:No Intervention
Arm Name:Delayed Treatment Control - Usual Care
Description:Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Study Arm Type:Experimental
Arm Name:Yoga
Description:The yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.