Back Pain Clinical Trial
Official title:
Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain
NCT number | NCT03892759 |
Other study ID # | 2019-006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 4, 2022 |
Verified date | April 2022 |
Source | Pacific Northwest University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 4, 2022 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult 18 years of age or older - Back pain - Able to arrange transportation and arrive to three study appointments. Exclusion Criteria: - May not have had manual treatment (massage, chiropractic, or OMT) in the last 90 days - May not have any labs or imaging for their back pain recommended by their physicians the subject has not yet completed - May not have had back surgery in past 60 days - May not be pregnant or have given birth in the last 30 days - May not have be unable to tell a member of the study team their name, city they live in and the current year. |
Country | Name | City | State |
---|---|---|---|
United States | Pacific Northwest University of Health Sciences | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Pacific Northwest University of Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Functional Status at 8 weeks | Functional Status as measured by Roland-Morris Disability Questionnaire. Question responses are totaled for a score of 0 to 24 with higher number indicating a worse outcome or greater level of disability. | 8 weeks | |
Primary | Change from Baseline Functional Status at 12 weeks | Functional Status as measured by Roland-Morris Disability Questionnaire. Question responses are totaled for a score of 0 to 24 with higher number indicating a worse outcome or greater level of disability. | 12 weeks | |
Primary | Change from Baseline Back Range of Motion at 3 weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument | 3 Weeks | |
Primary | Change from Baseline Back Range of Motion at 8 weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument | 8 weeks | |
Primary | Change from Baseline Back Pain at 3 weeks | Pain as measured by Visual Analog Scale (VAS). The scale indicates a level of pain from 0 to 10 with higher number associated with a worse outcome or greater level of pain. | 3 weeks | |
Primary | Change from Baseline Back Pain at 8 weeks | Pain as measured by Visual Analog Scale (VAS). The scale indicates a level of pain from 0 to 10 with higher number associated with a worse outcome or greater level of pain. | 8 weeks | |
Secondary | Change from Baseline Assessment of Quality of Life at 8 weeks | Quality of Life as measured by PROMIS Global Health Questionnaire. Total Physical Health Score of 7 to 17 with lower numbers indicating better physical health outcome and Total Mental Health Score of 8 to 16 with lower numbers indicating better mental health outcome. | 8 weeks | |
Secondary | Change from Baseline Assessment of Quality of Life at 12 weeks | Quality of Life as measured by PROMIS Global Health Questionnaire. Total Physical Health Score of 7 to 17 with lower numbers indicating better physical health outcome and Total Mental Health Score of 8 to 16 with lower numbers indicating better mental health outcome. | 12 weeks |
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