NCT02806323

Brief Summary

The goal of this pilot study is to determine the feasibility of an individually tailored yoga program delivered in a group setting for the treatment of chronic neck and back pain in a low income population. Chronic pain is one of the most common, costly, and disabling conditions, and is often refractory to treatment. Yoga is a promising treatment for chronic pain. This pilot study will test the hypothesis that study subjects will participate in a voluntary 12 week yoga intervention for the treatment of chronic neck and back pain, as assessed by attendance at 12 weekly yoga practice sessions. Secondary outcomes will include change in pain and quality of life scores over the 12 week study period as assessed by the Visual Analog Scale for Pain Severity and EQ-5D-3L.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

May 3, 2016

Last Update Submit

January 25, 2017

Conditions

Neck Pain MusculoskeletalBack Pain, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Program feasibility based on participant attendance and practice logs

    Feasibility of an individually tailored program of yoga for the treatment of chronic neck and/or back pain in a low-income population.

    12 weeks

Secondary Outcomes (2)

  • Visual Analog Scale for Pain Severity

    12 weeks

  • EQ-5D™ (European Quality of Life) Instrument

    12 weeks

Study Arms (1)

Yoga Practice

EXPERIMENTAL

12 week yoga intervention; 45 minutes/weekly practice Participants will be encouraged to practice their prescribed program of yoga at home, daily, for 20 minutes each day.

Other: Yoga practice

Interventions

Yoga practiceOTHER
Yoga Practice

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingra Clinic

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adrienne Hampton, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2016

First Posted

June 20, 2016

Study Start

July 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

US(1)