Osteopathic Manipulative Treatment for Back Pain

Study Overview
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Brief Summary
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This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.

Detailed Description
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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.

Official Title
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Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain

Conditions
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Lumbar Pain, Back Pain, Thoracic Pain, Somatic Dysfunction, Fascial Distortion

Intervention / Treatment
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* Other: Osteopathic Manipulative Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre/post prospective one group pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Evaluation and Treatment<br>Subjects will be evaluated through inspection and palpation of the thoracic and lumbar spine, and other body regions as necessary. The provider will make a diagnosis of somatic dysfunction based off the TART (tissue texture change, asymmetry, restriction of motion, tenderness/pain) findings. | Other: Osteopathic Manipulative Therapy<br>* A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Change from Baseline Back Range of Motion at 3 weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument | 3 Weeks | 
| Change from Baseline Back Range of Motion at 8 weeks | Range of Motion a measured by Back Range of Motion (BROM) Instrument | 8 weeks | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulative Treatment