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Osteopathic Manipulative Treatment for Back Pain

Primary Purpose

Back Pain, Lumbar Pain, Thoracic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Sponsored by
Pacific Northwest University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Osteopathic Manipulative Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pacific Northwest University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Evaluation and Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Change from Baseline Back Range of Motion at 3 weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Change from Baseline Back Range of Motion at 8 weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 22, 2019
Last Updated
April 20, 2022
Sponsor
Pacific Northwest University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03892759
Brief Title
Osteopathic Manipulative Treatment for Back Pain
Official Title
Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Northwest University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Lumbar Pain, Thoracic Pain, Somatic Dysfunction, Fascial Distortion
Keywords
Osteopathic Manipulative Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre/post prospective one group pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation and Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.
Primary Outcome Measure Information:
Title
Change from Baseline Functional Status at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from Baseline Functional Status at 12 weeks
Description
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.
Time Frame
12 weeks
Title
Change from Baseline Back Range of Motion at 3 weeks
Description
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Time Frame
3 Weeks
Title
Change from Baseline Back Range of Motion at 8 weeks
Description
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Time Frame
8 weeks
Title
Change from Baseline Back Pain at 3 weeks
Description
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.
Time Frame
3 weeks
Title
Change from Baseline Back Pain at 8 weeks
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Assessment of Quality of Life at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from Baseline Assessment of Quality of Life at 12 weeks
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Martin, DO
Organizational Affiliation
Assistant Professor of Osteopathic Principles and Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Northwest University of Health Sciences
City
Yakima
State/Province
Washington
ZIP/Postal Code
98901
Country
United States

12. IPD Sharing Statement

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Osteopathic Manipulative Treatment for Back Pain

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