Back PainNCT03892759
Osteopathic Manipulative Treatment for Back Pain
A study testing Osteopathic Manipulative Therapy in people with Back Pain and Lumbar Pain, run by Pacific Northwest University of Health Sciences at 1 site in United States.
Trial summary
This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Lumbar Pain, Thoracic Pain
- What is being tested?
- Osteopathic Manipulative Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years of age or older
- Back pain
- Able to arrange transportation and arrive to three study appointments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Northwest University of Health Sciences
Yakima, Washington, 98901
About this study
Official title: Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain
This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.
Read the 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.
- Conditions
- Back Pain, Lumbar Pain, Thoracic Pain, Somatic Dysfunction, Fascial Distortion
- Being tested
- Osteopathic Manipulative Therapy
- Keywords
- Osteopathic Manipulative Treatment
- Medical subject headings
- Back Pain, Low Back Pain, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyOther
A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Osteopathic Manipulative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Change from Baseline Back Range of Motion at 3 weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Measured: 3 Weeks
Change from Baseline Back Range of Motion at 8 weeks
Range of Motion a measured by Back Range of Motion (BROM) Instrument
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Aug 2019
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post prospective one group pilot study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Martin, Pacific Northwest University of Health Sciences
- Investigators
- Crystal Martin, DO, Principal investigator, Assistant Professor of Osteopathic Principles and Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892759
- Sponsor's protocol ID
- 2019-006
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain
- ClinicalTrials.gov ID
- NCT03892759
- Acronym / sponsor ID
- 2019-006
- Conditions
- Back Pain, Lumbar Pain, Thoracic Pain, Somatic Dysfunction, Fascial Distortion
- Keywords
- Osteopathic Manipulative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pacific Northwest University of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post prospective one group pilot study
| Arm | Type | Receives |
|---|---|---|
| Evaluation and Treatment | Other | Other: Osteopathic Manipulative TherapySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18 years of age or older
- Back pain
- Able to arrange transportation and arrive to three study appointments.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TherapyA set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction. | Other | Evaluation and Treatment |
Primary outcome
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.
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.
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
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
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.
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.
2 secondary outcomes
Change from Baseline Assessment of Quality of Life at 8 weeks
Time frame: 8 weeks
Change from Baseline Assessment of Quality of Life at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Martin, DO principal investigator
Assistant Professor of Osteopathic Principles and Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Therapy in people with Back Pain and Lumbar Pain, run by Pacific Northwest University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Functional Status at 8 weeks (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.