Osteopathic Manipulative Treatment for Back Pain

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

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

Study Overview

• Status: Completed
• Conditions: Back Pain; Somatic Dysfunction; Lumbar Pain; Thoracic Pain; Fascial Distortion
• Intervention / Treatment: Other: Osteopathic Manipulative Therapy

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Yakima, Washington, United States, 98901
      • Pacific northwest university of health sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Evaluation and Treatment; 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; A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pacific Northwest University of Health Sciences
• Investigators: Principal Investigator: Crystal Martin, DO, Assistant Professor of Osteopathic Principles and Practice

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Osteopathic Manipulative Treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 2019-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No