TeleYoga for Chronic Low Back Pain: A Quantitative and Qualitative Study

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorTaylor Rees

About this trial

Chronic low back pain (CLBP) is a highly prevalent and debilitating condition, affecting 84% of the population over a lifetime1. CLBP is the leading cause of disability worldwide 2 and is a top condition for health care expenditure in the US3. Emerging evidence indicates that individuals with low back pain have altered neurophysiological processes within the central nervous system leading to high prevalence of anxiety and depression, and poor sleep quality4-7. Standard treatments often focus on the local source of pain; however, for many patients the persistence and severity of pain cannot be explained by peripheral pathology alone. Yoga is a promising mind-body integrative intervention, as it targets the psychological and neurophysiological aspects of pain. The efficacy of yoga practice for reducing pain8,9 and psychological distress10,11 has been shown by many systematic reviews and randomized control trials (RCTs)12-16. Additionally, mindfulness, meditation, and breathwork interventions produce meaningful improvements in pain17,18, anxiety19,20, depression21, and sleep quality22,23.

Evidence clearly indicates yoga is an effective intervention for management of chronic LBP9. However, the majority of prior RCTs have included in-person yoga sessions 24-26, which may be a barrier to many people. Recently, virtual delivery of interventions is gaining popularity. A few recent studies reported promising feasibility of tele-yoga in people with various chronic pain conditions e.g. Alzheimer's 27, dementia 28, and knee osteoarthritis 29. Only one recent RCT conducted tele-yoga intervention for people with CLBP and resulted in decreased pain 14, but is limited to quantitative measures only and did not compare yoga against active therapy. No study has assessed participants' perspective of virtual yoga intervention for chronic low back pain, which is important to determine feasibility of tele-yoga for CLBP management. The objectives of this study are two fold: 1) to investigate the acceptability of yoga intervention using a tele-yoga approach and 2) to compare the effectiveness of a tele-yoga intervention with a mindfulness focus (Y+M) to a tele-yoga intervention without a mindfulness focus (Y-M) in adults with CLBP.

Thirty participants27,30 with CLBP aged 30-8014 will be recruited and randomly assigned to Y+M or time-matched Y-M (physical movement without breathing and meditation) group. Each group will participate in video-guided live group sessions 2x a week for 4 weeks28,30.

Aim 1: To evaluate acceptability of tele-yoga intervention for CLBP. The investigators will assess acceptability via participants' overall satisfaction using 1) self-reported satisfaction ratings, the Acceptability of Intervention Measure (AIM)31 and 2) semi-structured qualitative interviews to capture participant feedback about their experience (e.g. barriers, facilitators, motivators, perceived effectiveness, self-efficacy). Hypothesis 1: Participants will have good acceptability to tele-yoga intervention.

Aim 2: To compare between-group changes in pain and function between tele-yoga with breath regulation, focused attention/meditation and tele-yoga without breath regulation, focused attention/meditation. Efficacy of tele-yoga on pain and function between groups will be assessed at baseline, midpoint, and post-intervention. Pain (VAS) and function (ODI) will serve as primary outcomes. Clinically significant improvement is defined as ODI scores ≥15% and reductions in VAS pain scores ≥2 points as compared to the sham yoga group. Secondary outcomes will include PROMIS Pain Interference Short Form. Hypothesis 2: The Y+M will have greater improvements than the YG.

Aim 3: To compare between-group changes in psychological health between tele-yoga with breath regulation, focused attention/meditation and tele-yoga without breath regulation, focused attention/meditation. Psychological measures include Beck Anxiety Inventory, Beck Depression Inventory, Pittsburg Sleep Quality Index and compared between both groups. Secondary measures include symptoms of CS with standard measures of Fibromyalgia 2016 (FM) survey32. Hypothesis 3: The Y+M will have greater improvements than the Y-M.

This project is highly innovative in its focus on 1) gaining participants' perspective with tele-yoga delivery and 2) telehealth-delivered, mind-body intervention specifically targeting central pain sensitization in CLBP with potential exploration of underlying mechanisms of yoga. The project is significant with potentially improving access to virtual treatment options that may potentially lead to self-management of CLBP. Expected outcomes of this research include evidence to support tele-yoga as an effective, accessible integrative therapy for reducing centrally mediated pain symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

30-80 year old individuals

Ability to speak, read and write English as needed for study LBP for 3 months with frequency of 2 or more days/week or daily low back pain for the most recent three months

Pain intensity minimum 3 on 0-10 pain scale where 0=no pain and 10=maximum pain imagined

Have internet access and device available for logging into virtual yoga classes

Disqualifiers

spine compression, tumor, infection, spine surgery within the last 12 months

neurological conditions such as stroke, Parkinson's disease, Alzheimer's disease or other cognitive impairments.

pregnancy

currently performing yoga or has performed yoga on a regular basis within the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yoga

    Behavioral

    Physical Yoga postures

  • Mindfulness

    Behavioral

    breathing cues or meditation practice

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Yoga + MindfulnessExperimental treatment 2 interventions
Group B: Yoga - MindfulnessActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Semi Structured Interview

This interview will take about 30-60 minutes, but we can take a break anytime you need to. If you need to end the interview at any time, please let me know and we will stop. Do you have any other questions before we start? Are you still willing to continue with this interview? Do you mind if we start the audio-recorder? 1. I would like to begin this interview by asking you, before you started this project what your experience with yoga was. 1. \[Clarifying probe\]: Had you ever practiced yoga before? 2. \[If have practiced before\]: Prior to this project what were your main goals for doing yoga? How many times a week were you doing yoga? 3. \[If have not practiced before\] What led you to want to take part in this yoga program? 2. Why did you join a yoga study?: 1. \[Clarifying probe\]: Before you started this program, what were you hoping to get out of doing yoga? 2. \[Clarifying probe\]: What did you hope doing this yoga program would do for you? 3. What was your overall experienc

Time frame
Week 4
2

Acceptability of Intervention Measure (AIM)

Acceptability of Intervention Measure (AIM) 1. \[Triple P/Implementation Strategy\] meets my approval. 2. \[Triple P/Implementation Strategy\] is appealing to me. 3. I like \[Triple P/Implementation Strategy\]. 4. I welcome \[Triple P/Implementation Strategy\]. Intervention Appropriateness Measure (IAM) 1\) \[Triple P/Implementation Strategy\] seems fitting. 2) \[Triple P/Implementation Strategy\] seems suitable. 3) \[Triple P/Implementation Strategy\] seems applicable. 4) \[Triple P/Implementation Strategy\] seems like a good match. Feasibility of Intervention Measure (FIM) 1. \[Triple P/Implementation Strategy\] seems implementable. 2. \[Triple P/Implementation Strategy\] seems possible. 3. \[Triple P/Implementation Strategy\] seems doable. 4. \[Triple P/Implementation Strategy\] seems easy to use.

Time frame
Week 0, Week 2, Week 4

Secondary outcomes

1

Oswestry Disability Index

Section 1 - Pain intensity I have no pain at the moment The pain is very mild at the moment The pain is moderate at the moment The pain is fairly severe at the moment The pain is very severe at the moment The pain is the worst imaginable at the moment Section 2 - Personal care (washing, dressing etc) I can look after myself normally without causing extra pain I can look after myself normally but it causes extra pain It is painful to look after myself and I am slow and careful I need some help but manage most of my personal care I need help every day in most aspects of self-care I do not get dressed, I wash with difficulty and stay in bed Section 3 - Lifting I can lift heavy weights without extra pain I can lift heavy weights but it gives extra pain Pain prevents me from lifting heavy weights off the floor, but I can manage if they are conveniently placed eg. on a table Pain prevents me from lifting heavy weights

Time frame
Week 0, Week 2, Week 4
2

Promis Short Form

The PROMIS Pain Short Form are short, reliable surveys that measure how much pain someone has (intensity), how much it gets in the way of life (interference), and sometimes how much it shows on the outside (behavior). They are quick to administer, produce standardized T-scores, and are widely used in clinical trials and practice to monitor pain outcomes.

Time frame
Week 0, Week 2, Week 4
3

Visual Analog Scale

Pain rating 0-10 at current, best, worst, and average

Time frame
Weekly
4

Beck Anxiety Index

The BAI is a self-report questionnaire that measures the severity of anxiety. It contains 21 multiple-choice questions; each answer is scored on 0 (not at all) to 3 (severely) scale. Higher scores indicate more severe anxiety symptoms.

Time frame
Week 0, Week 2, Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taylor Rees

Lead sponsor

University of Kansas Medical Center

Sponsor institution