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This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Self-management education session occurred monthly within the community. Group yoga intervention was delivered two times a week with a specifically designed program that was progressively more difficult. Assessments were then administered pre and post intervention, and a semi-structured interview was completed following the intervention. Quantitative and qualitative data were then compared between groups.
This was a randomized control trial completed with two specific aims.
Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with an ongoing self-management education for people with chronic pain.
Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with chronic pain. The key variables of interest were pain interference, functional performance, balance, strength, mobility, and quality of life (QoL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Arm | Experimental | Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. |
|
| Wait-list Control Arm | Experimental | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Other | The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory--Short Form | The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arlene Schmid, PhD | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic | Fort Collins | Colorado | 80524 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29526474 | Derived | Schmid AA, Atler KE, Malcolm MP, Grimm LA, Klinedinst TC, Marchant DR, Marchant TP, Portz JD. Yoga improves quality of life and fall risk-factors in a sample of people with chronic pain and Type 2 Diabetes. Complement Ther Clin Pract. 2018 May;31:369-373. doi: 10.1016/j.ctcp.2018.01.003. Epub 2018 Feb 15. |
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Recruitment completed - all completed at a pain clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Arm | Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. Yoga: The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
| FG001 | Wait-list Control Arm | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Arm | Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. Yoga: The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory--Short Form | The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
Participants were monitored for adverse events for the full duration of the study - 1 year.
Both groups had adverse events monitored throughout the study. The waitlist cohort was offered yoga for up to 16 weeks, however, the primary endpoint was measured after 8 weeks of yoga/waitlist control. All adverse events are reflected in the chart below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Arm | Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. Yoga: The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arlene Schmid | Colorado State University | 9704917562 | arlene.schmid@colostate.edu |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Self-management | Other | The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
|
| BG001 | Wait-list Control Arm | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Brief Pain Inventory | Scale is measured from 0-10, with a higher score indicating worse pain severity and interference on everyday life. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Wait-list Control Arm | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Wait-list Control Arm | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. Self-management: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. | 0 | 39 | 0 | 39 |
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| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |