Osteopathic Manipulative Treatment for Back Pain

Not Applicable

Completed

• Conditions: Somatic Dysfunction; Fascial Distortion; Lumbar Pain; Thoracic Pain; Back Pain
• Interventions: Other: Osteopathic Manipulative Therapy

• Registration Number: NCT03892759
• Lead Sponsor: Pacific Northwest University of Health Sciences

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 Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2022-03-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation and Treatment	Osteopathic Manipulative Therapy	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.

Primary Outcome Measures

Name	Time	Method
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
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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Pacific Northwest University of Health Sciences; 🇺🇸 Yakima, Washington, United States