Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Change from Baseline Functional Status at 8 weeks
Study Overview
Brief Summary
This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.
Detailed Description
Low back pain is the most common cause of disability in people under age 45 and accounts for 20% of all physician visits. Osteopathic manual treatment (OMT) has been used to manage patients with acute and chronic back pain. These treatments are often reported as beneficial by patients.
This study will examine the effect on functional status, range of motion, quality of life, and pain with Osteopathic Manipulative Treatment (OMT). Baseline will be defined as someone who has never had OMT, chiropractic, or massage, or has not received such treatments in the last 90 days. Back pain will be specific to pain presenting in the lumbar or thoracic regions of the spine.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change from Baseline Functional Status at 8 weeks
Time Frame: 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.
Change from Baseline Functional Status at 12 weeks
Time Frame: 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.
Change from Baseline Back Range of Motion at 3 weeks
Time Frame: 3 Weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Change from Baseline Back Range of Motion at 8 weeks
Time Frame: 8 weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Change from Baseline Back Pain at 3 weeks
Time Frame: 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.
Change from Baseline Back Pain at 8 weeks
Time Frame: 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.
Secondary Outcomes
- Change from Baseline Assessment of Quality of Life at 8 weeks(8 weeks)
- Change from Baseline Assessment of Quality of Life at 12 weeks(12 weeks)
Investigators
Crystal Martin
Principal Investigator
Pacific Northwest University of Health Sciences