Osteopathic Manipulative Treatment for Back Pain

NCT03892759 | Completed

• 1 other identifier: 2019-006
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Osteopathic Manipulative Treatment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Change from Baseline Assessment of Quality of Life at 8 weeks

  8 weeks

• Change from Baseline Assessment of Quality of Life at 12 weeks

  12 weeks

Study Arms (1)

Evaluation and Treatment

OTHER

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

Interventions

Osteopathic Manipulative Therapy OTHER

A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.

Evaluation and Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 years of age or older
• Back pain
• Able to arrange transportation and arrive to three study appointments.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacific Northwest University of Health Sciences: lead

Study Sites (1)

Pacific Northwest University of Health Sciences

Yakima, Washington, 98901, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain; Chest Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Crystal Martin, DO

  Assistant Professor of Osteopathic Principles and Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre/post prospective one group pilot study

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 27, 2019
• Study Start: April 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: March 4, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

US (1)