N/A N=152 Randomized Single-blind Treatment

Yoga for Veterans With CLBP

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT02524158 ↗

Enrolled (actual)

152

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Roland-Morris Disability Questionnaire — -2.05; -1.29 units on a scale — p=0.340

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Yoga Therapy for CLBP (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Roland-Morris Disability Questionnaire	-3.37; -0.89	0.003 sig
PRIMARY Roland-Morris Disability Questionnaire	-3.37; -0.89	0.003 sig
SECONDARY Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks	-0.61; 0.04	0.005 sig
SECONDARY Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months	-0.44; 0.15	0.013 sig
SECONDARY Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks	-0.85; -0.21	0.044 sig
SECONDARY Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks	-5.29; 0.82	<0.01 sig
SECONDARY Change From Baseline - SF12 PCS at 12 Weeks	4.40; 0.58	0.010 sig
SECONDARY Change From Baseline - SF12 MCS at 12 Weeks	-0.04; -0.43	0.66
SECONDARY Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks	0.077; 0.018	<0.10
SECONDARY Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks	-1.6; -0.63	0.202
SECONDARY Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks	-1.69; 0.23	0.369
SECONDARY Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks	-1.56; -0.082	0.50
SECONDARY Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks	0.26; -0.48	0.067
SECONDARY Attendance/ Home Practice	12.28	—
SECONDARY Change From Baseline - Range of Motion - Flexion at 12 Weeks	7.41; 2.65	0.071
SECONDARY Change From Baseline - Grip Strength at 12 Weeks	-0.30; 0.62	0.92
SECONDARY Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks	6.21; 1.05	0.036 sig
SECONDARY Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks	18.70; 10.50	0.071

Summary

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.

Eligibility 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
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02524158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.