Neck Pain MusculoskeletalNCT02806323
Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain
A study testing Yoga practice in people with Neck Pain Musculoskeletal and Back Pain, Unspecified, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain Musculoskeletal, Back Pain, Unspecified
- What is being tested?
- Yoga practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain in a Low-income Population: A Feasibility Study
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.
Read the 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.
- Conditions
- Neck Pain Musculoskeletal, Back Pain, Unspecified
- Being tested
- Yoga practice
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga practiceOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain MusculoskeletalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne Hampton, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806323
- Sponsor's protocol ID
- 2014-1582
- Status last verified
- Jan 2017
- First submitted
- 3 May 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individually Tailored Yoga Program for the Treatment of Chronic Neck and Back Pain in a Low-income Population: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02806323
- Acronym / sponsor ID
- 2014-1582
- Conditions
- Neck Pain Musculoskeletal, Back Pain, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Practice | Experimental | Other: Yoga practice12 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga practice | Other | Yoga Practice |
Primary outcome
Program feasibility based on participant attendance and practice logs
Time frame: 12 weeks
Feasibility of an individually tailored program of yoga for the treatment of chronic neck and/or back pain in a low-income population.
2 secondary outcomes
Visual Analog Scale for Pain Severity
Time frame: 12 weeks
EQ-5D™ (European Quality of Life) Instrument
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Hampton, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga practice in people with Neck Pain Musculoskeletal and Back Pain, Unspecified, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program feasibility based on participant attendance and practice logs (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.