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

NCT ID: NCT06979713

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga, Pain Education, Yoga Nidra

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

Group Type EXPERIMENTAL

yoga, pain education, yoga nidra

Intervention Type 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, Relaxing Music

Yoga postures targeting lower back, pain education, relaxing music

Group Type ACTIVE_COMPARATOR

yoga, pain education, relaxing music

Intervention Type 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.

Interventions

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yoga, pain education, yoga nidra

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.

Intervention Type OTHER

yoga, pain education, relaxing music

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Abigail Wilson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Abigail Anderson

Role: CONTACT

4078231026

Other Identifiers

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11

Identifier Type: -

Identifier Source: org_study_id

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