Remotely Delivered Yoga Program for Chronic Low Back Pain

NCT ID: NCT04773743

Last Updated: 2021-02-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic pain yoga meditation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

chronic nonspecific low back pain

Remotely delivered yoga intervention

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

Remotely delivered yoga intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yoga

Remotely delivered yoga intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Maryland, College Park

OTHER

Sponsor Role collaborator

Maryland University of Integrative Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlysa Sullivan, MPT

Role: PRINCIPAL_INVESTIGATOR

Maryland University of Integrative Health

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marlysa Sullivan, MPT

Role: CONTACT

Phone: 4108889048

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07.SUL.10.20.2

Identifier Type: -

Identifier Source: org_study_id