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Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain

Primary Purpose

Neck Pain Musculoskeletal, Back Pain, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga practice
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neck Pain Musculoskeletal

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria will include neck and/or back pain on at least 5 days per week for >3 months, between ages 30-65, patient at Wingra family medical center, English or Spanish fluency.

Exclusion Criteria:

  • Exclusion criteria will include regular yoga practice in the last 12 months, pregnancy, non-ambulatory, known metastatic lesions to bone, history of pathologic fracture, history of back or neck surgery in the past 6 weeks or planned in the next 6 months, psychotic mental health disorder, lack of decisional capacity, inability to adhere to proposed intervention and follow-up schedule.

Sites / Locations

  • Wingra Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga Practice

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analog Scale for Pain Severity
Visual Analog Scale for Pain Severity demonstrate positive relations to other self-report measures of pain intensity, to observed pain behavior and are sensitive to treatment effects.
EQ-5D™ (European Quality of Life) Instrument
EQ-5D™ is a standardized instrument for use as a measure of health outcome and quality of life.

Full Information

First Posted
May 3, 2016
Last Updated
January 25, 2017
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02806323
Brief Title
Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain
Official Title
An Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain in a Low-income Population: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This will be a pilot study involving only one group to assess the feasibility of an individually tailored program of yoga for the treatment of chronic neck and back pain. All study procedures will be completed in English and Spanish by study team members fluent in these languages, and using study materials printed in English and in Spanish. Potential participants will be recruited through flyers and referrals from providers at Wingra Family Medical Center. Interested potential participants will undergo screening in person or over the phone which will take approximately 15 minutes. If they are determined to be eligible, potential participants will meet with a member of the research team to receive information about the study and sign the consent form if they so choose. Consent will take approximately 15 minutes. Demographic information will be collected at the time consent is signed, this will take an additional 10 minutes. Following this, participants will have a 90 minute intake session with Adrienne Hampton, MD, RYT 200 [RYT 200 is the designation for a Registered Yoga Teacher with 200 hours of training] where the pain history will be elicited and the yoga program will be developed. Following this, participants will be encouraged to participate in the weekly drop-in practice sessions, where they will choose how much time they would like to spend asking questions, and receiving one on one practice instruction from Dr. Hampton. Participants will be encouraged to spend at least 45 minutes at the weekly practice session, which will include 10 minutes for completion of questionnaires. Participants will also be encouraged to practice their prescribed program of yoga at home, daily, for 20 minutes each day. The primary outcome measured will be attendance at yoga practice sessions. Additionally, indices of pain and quality of life will be assessed before, during, and after the study either in person or over the phone. Participants will also submit home yoga practice logs. All participants will be asked to complete a 30 minute exit interview in person at the end of the 12 week intervention period. The questionnaires are administered on paper, and participants will record their answers on paper. For the exit interview, the interviewer will read the questions to the participant, and then the interviewer will scribe on paper the participant's answers to the questions.Participants will be provided with bus passes to facilitate travel to study activities, and will be paid up to $50 for study participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain Musculoskeletal, Back Pain, Unspecified

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Practice
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga practice
Primary Outcome Measure Information:
Title
Program feasibility based on participant attendance and practice logs
Description
Feasibility of an individually tailored program of yoga for the treatment of chronic neck and/or back pain in a low-income population.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain Severity
Description
Visual Analog Scale for Pain Severity demonstrate positive relations to other self-report measures of pain intensity, to observed pain behavior and are sensitive to treatment effects.
Time Frame
12 weeks
Title
EQ-5D™ (European Quality of Life) Instrument
Description
EQ-5D™ is a standardized instrument for use as a measure of health outcome and quality of life.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria will include neck and/or back pain on at least 5 days per week for >3 months, between ages 30-65, patient at Wingra family medical center, English or Spanish fluency. Exclusion Criteria: Exclusion criteria will include regular yoga practice in the last 12 months, pregnancy, non-ambulatory, known metastatic lesions to bone, history of pathologic fracture, history of back or neck surgery in the past 6 weeks or planned in the next 6 months, psychotic mental health disorder, lack of decisional capacity, inability to adhere to proposed intervention and follow-up schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne Hampton, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wingra Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain

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