Clinical trial NCT03892759: 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
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lumbar Pain
Thoracic Pain
Somatic Dysfunction
Fascial Distortion
Keywords: Osteopathic Manipulative Treatment
Lead sponsor: Pacific Northwest University of Health Sciences
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/post prospective one group pilot study
Primary purpose: 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.

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.

Primary outcomes:
measure: Change from Baseline Functional Status at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Functional Status at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Back Range of Motion at 3 weeks
timeFrame: 3 Weeks
measure: Change from Baseline Back Range of Motion at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Back Pain at 3 weeks
timeFrame: 3 weeks
measure: Change from Baseline Back Pain at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline Assessment of Quality of Life at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Assessment of Quality of Life at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yakima
country: United States
facility: Pacific Northwest University of Health Sciences
state: Washington
Study officials:
affiliation: Assistant Professor of Osteopathic Principles and Practice
name: Crystal Martin, DO
role: PRINCIPAL_INVESTIGATOR
References: