Back Pain, Fascial Distortion, Lumbar Pain, Somatic Dysfunction, Thoracic Pain
Conditions
Keywords
Osteopathic Manipulative Treatment
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.
Interventions
A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.
Sponsors
Pacific Northwest University of Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre/post prospective one group pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Back Pain at 8 weeks | 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. |
| Change from Baseline Back Range of Motion at 8 weeks | 8 weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument |
| Change from Baseline Back Pain at 3 weeks | 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 Functional Status at 8 weeks | 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 | 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 | 3 Weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Assessment of Quality of Life at 12 weeks | 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. |
| Change from Baseline Assessment of Quality of Life at 8 weeks | 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. |
Countries
United States
Outcome results
None listed