Yoga, Education, and Nidra (YEN) for Chronic Low Back Pain: A Pilot Study on Pain Modulation, Well-Being, and Sleep

NCT06979713 | Not Yet Recruiting

• 1 other identifier: 11
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the impact of yoga, pain education, and yoga nidra with pain acceptance intention to yoga, pain education, and relaxing music on pain intensity, well-being, and sleep quality. This is a pilot study trial of individuals with chronic low back pain. Participants will attend two sessions in the laboratory (week 1 and week 8) and complete their assigned intervention 2 x per week for 6 weeks at home. Participants will be randomized to either receive yoga postures targeting the low back, pain education, and yoga nidra with pain acceptance intention and motor imagery or yoga postures targeting the low back, pain education, and relaxing music.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Numeric Pain Rating Scale

  Participants will rate their low back pain from 0=no pain to 100=worst pain imaginable.

  Completed on week one and week eight

• Warwick-Edinburgh Mental Well-Being Scale

  Self-report measure of well-being

  Completed on week one and week eight

• Pittsburgh Sleep Quality Index

  Self-report measure of sleep quality

  Completed on week one and week eight

Study Arms (2)

Yoga, Pain Education, Yoga Nidra

EXPERIMENTAL

Yoga postures targeting lower back, pain education, yoga nidra with pain acceptance intention and motor imagery.

Other: yoga, pain education, yoga nidra

Yoga, Pain Education, Relaxing Music

ACTIVE COMPARATOR

Yoga postures targeting lower back, pain education, relaxing music

Other: yoga, pain education, relaxing music

Interventions

yoga, pain education, yoga nidra OTHER

Participants will complete a series of yoga postures targeting the lower back combined with pain education. The session will conclude with either yoga nidra with pain acceptance intention. Interventions are completed at home 2x/week for 6 weeks.

Yoga, Pain Education, Yoga Nidra

yoga, pain education, relaxing music OTHER

Participants will complete a series of yoga postures targeting the lower back combined with pain education. The session will conclude with relaxing music depending on group assignment. Interventions are completed at home 2x/week for 6 weeks.

Yoga, Pain Education, Relaxing Music

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain in lower back that has lasted for over three months
• Pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable)

You may not qualify if:

• non-English speaking
• systemic medical conditions that affect sensation (such as uncontrolled diabetes)
• History of surgery or fracture within the past six months
• any blood clotting disorders (such as hemophilia)
• any contraindication to the application of ice (blood pressure \> 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
• Exceed pressure and heat sensory thresholds
• Unable to access the internet or email
• Pregnant
• Unable to exercise without medical clearance (assessed on PAR-Q+ on first visit)

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Yoga

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

Central Study Contacts

Abigail Anderson

CONTACT

4078231026; Abigail.Wilson@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)