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

NCT07216417 | Active Not Recruiting

• 1 other identifier: STUDY00161902
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

yoga; mindfulness

Outcome Measures

Primary Outcomes (2)

• 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

  Week 4

• 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.

  Week 0, Week 2, Week 4

Secondary Outcomes (7)

• Oswestry Disability Index

  Week 0, Week 2, Week 4

• Promis Short Form

  Week 0, Week 2, Week 4

• Visual Analog Scale

  Weekly

• Beck Anxiety Index

  Week 0, Week 2, Week 4

• Beck Depression Inventory

  Week 0, Week 2, Week 4

Study Arms (2)

Yoga + Mindfulness

EXPERIMENTAL

These participants will synchronously on zoom watch 2 recorded classes with a coach to guide them. Classes are 2x a week for 4 weeks. Their classes will be a mix of physical yoga postures and mindfulness ie meditation and breathing exercises.

Behavioral: Yoga; Behavioral: Mindfulness

Yoga - Mindfulness

ACTIVE COMPARATOR

These participants will synchronously on zoom watch 2 recorded classes with a coach to guide them. Classes are 2x a week for 4 weeks. Their classes will only be physical yoga postures

Behavioral: Yoga

Interventions

Yoga BEHAVIORAL

Physical Yoga postures

Yoga + Mindfulness; Yoga - Mindfulness

Mindfulness BEHAVIORAL

breathing cues or meditation practice

Yoga + Mindfulness

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Be able to get on and off the floor

You may not qualify if:

• 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

Sponsors & Collaborators

• Taylor Rees: lead

Study Sites (1)

Department of Physical Therapy, Rehabilitation Science, and Athletic Training

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Yoga; Mindfulness

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 14, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)