Osteopathic Manipulative Treatment for Back Pain

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892759
• Other study ID #: 2019-006
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 4, 2022

Study information

• Verified date: April 2022
• Source: Pacific Northwest University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 4, 2022
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Fascial Distortion
• Lumbar Pain
• Somatic Dysfunction
• Thoracic Pain

Intervention

Other:
• Osteopathic Manipulative Therapy
A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.

Locations

Country	Name	City	State
United States	Pacific Northwest University of Health Sciences	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Northwest University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from Baseline Back Range of Motion at 3 weeks	Range of Motion a measured by Back Range of Motion (BROM) Instrument	3 Weeks
Primary	Change from Baseline Back Range of Motion at 8 weeks	Range of Motion a measured by Back Range of Motion (BROM) Instrument	8 weeks
Primary	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
Primary	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	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
Secondary	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