NCT04773743

Brief Summary

The purpose of this research is to integrate the meditative components of integrative restoration (iRest) yoga nidra with simple and safe movement sequences derived from established yoga postures and physical therapy interventions for chronic nonspecific low back pain and to use telemedicine technology to facilitate the intervention in a diverse socioeconomic and racial/ethnic population. This project will first systematically adapt the iRest yoga intervention for the incorporation of movement using a consultative and iterative process followed by a pilot intervention to assess the acceptability and preliminary efficacy of this program for pain, back related function and to address body-mind regulation and biopsychosocial-spiritual well-being. Hypothesis: a yoga intervention emphasizing meditative movement and relaxation will be safe for remote delivery and effective for biopsychosocial-spiritual outcomes for people with chronic low back pain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable low-back-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

January 22, 2021

Last Update Submit

February 24, 2021

Conditions

Low Back Pain

Keywords

chronic painyogameditation

Outcome Measures

Primary Outcomes (1)

  • Change in Oswestry Disability Index

    Back related function and pain

    Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up

Secondary Outcomes (4)

  • Change in Vagal Efficiency

    Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up

  • Change in Purpose in Life

    Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up

  • Change in Body Brain Center Sensory Scales

    Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up

  • Change in Body Perception Questionnaire subscale on autonomic reactivity

    Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up

Study Arms (1)

chronic nonspecific low back pain

EXPERIMENTAL

Remotely delivered yoga intervention

Other: Yoga

Interventions

YogaOTHER

Remotely delivered yoga intervention

chronic nonspecific low back pain

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults age 18-64 years who report chronic nonspecific low back pain, defined as low back pain of unknown etiology persisting for at least 12 weeks,
  • Participants must report an average pain intensity in the previous week of 4 or greater on an 11-point (0 to 10) numerical rating scale,
  • Demonstrate medium to high risk on the STarT back screening tool,
  • Understand English
  • Have access to technology including a computer and internet access

You may not qualify if:

  • Specific causes of low back pain (e.g. spinal fractures, cancer-related pain)
  • Severe or progressive neurological deficits
  • Severe chronic medical and/or psychiatric comorbidities that may prevent safe participation in the study
  • Established pregnancy
  • Current yoga practice or regular yoga class attendance in the last three months;
  • Current application for a receipt of workers compensation
  • lack of access to technology including a computer and the internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marlysa Sullivan, MPT

    Maryland University of Integrative Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlysa Sullivan, MPT

CONTACT

4108889048msullivan1@muih.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 26, 2021

Study Start

February 15, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data