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Completed

NCT Number: NCT03892759

Osteopathic Manipulative Treatment for Back Pain

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

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Key information

Conditions

Back Pain Chest Pain Fascial Distortion Low Back Pain Lumbar Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatic Dysfunction Thoracic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Northwest University of Health Sciences

Yakima, Washington, 98901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic Manipulative Therapy

Other

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

Primary outcomes

  1. Change from Baseline Functional Status at 8 weeks

    Time frame: 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.

  2. Change from Baseline Functional Status at 12 weeks

    Time frame: 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.

  3. Change from Baseline Back Range of Motion at 3 weeks

    Time frame: 3 Weeks

    Range of Motion a measured by Back Range of Motion (BROM) Instrument

  4. Change from Baseline Back Range of Motion at 8 weeks

    Time frame: 8 weeks

    Range of Motion a measured by Back Range of Motion (BROM) Instrument

  5. Change from Baseline Back Pain at 3 weeks

    Time frame: 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.

  6. Change from Baseline Back Pain at 8 weeks

    Time frame: 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 outcomes

  1. Change from Baseline Assessment of Quality of Life at 8 weeks

    Time frame: 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.

  2. Change from Baseline Assessment of Quality of Life at 12 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pacific Northwest University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Mar 27, 2019
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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