Low Back PainPhase 3NCT00315120
Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
A Phase 3 study testing A. Active OMT and active UST in people with Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- A. Active OMT and active UST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
- Must identify the low back as the primary site of pain
- Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
- Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)
Who cannot join
- History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
- History of surgery involving the low back within the past year or planned low back surgery in the future
- History of receiving Workers' Compensation benefits within the past three months
- Involvement in current litigation relating to back problems
- Current pregnancy or plan to become pregnant during the course of participation in the study
- Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
Show all 10Show fewer
- Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
- Use of intravenous, intramuscular, or oral corticosteroids within the past month
- History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
- Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Osteopathic Research Center
Fort Worth, Texas, 76107
About this study
Official title: A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.
Read the detailed description
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.
- Conditions
- Low Back Pain
- Being tested
- A. Active OMT and active UST, B. Sham OMT and active UST, C. Active OMT and sham UST, D. Sham OMT and sham UST
- Keywords
- Randomized controlled trial, Low back pain, Spinal manipulative therapy, Spinal manipulation, Osteopathic manipulation, Osteopathic medicine, Physical therapy modalities
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A. Active OMT and active USTProcedure or surgery
Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
B. Sham OMT and active USTProcedure or surgery
Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
C. Active OMT and sham USTProcedure or surgery
Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
D. Sham OMT and sham USTProcedure or surgery
Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
| Study group | Role | What they receive |
|---|---|---|
| A (Active OMT and active (UST) | Other | Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy Receives: Procedure: A. Active OMT and active UST |
| B (Sham OMT and active UST) | Other | Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy Receives: Procedure: B. Sham OMT and active UST |
| C (Active OMT and sham UST) | Other | Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy Receives: Procedure: C. Active OMT and sham UST |
| D (Sham OMT and sham UST) | Other | Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy Receives: Procedure: D. Sham OMT and sham UST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
Measured: 12 weeks
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
Measured: 12 weeks
Secondary outcomes (24)
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 4 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 8 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 12 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 4 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 8 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Measured: 12 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 4 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 8 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 12 weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 4 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 8 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)
The general health scale ranges from 0 to 100, with higher scores representing better general health.
Measured: 12 Weeks
Work Disability (OMT and Sham OMT - Week 4)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 4 weeks
Work Disability (OMT and Sham OMT - Week 8)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 8 weeks
Work Disability (OMT and Sham OMT - Week 12)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 12 weeks
Work Disability (UST and Sham UST - Week 4)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 4 weeks
Work Disability (UST and Sham UST - Week 8)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 8 weeks
Work Disability (UST and Sham UST - Week 12)
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Measured: 12 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 4)
Subjects who reported being very satisfied with back care
Measured: 4 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 8)
Subjects who reported being very satisfied with back care
Measured: 8 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 12)
Subjects who reported being very satisfied with back care
Measured: 12 weeks
Satisfaction With Back Care (UST and Sham UST - Week 4)
Subjects who reported being very satisfied with back care
Measured: 4 weeks
Satisfaction With Back Care (UST and Sham UST - Week 8)
Subjects who reported being very satisfied with back care
Measured: 8 weeks
Satisfaction With Back Care (UST and Sham UST - Week 12)
Subjects who reported being very satisfied with back care
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 posted17 Apr 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Low 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Osteopathic Heritage Foundations, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center
- Investigators
- John C. Licciardone, DO, MS, MBA, Principal investigator, The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315120
- Sponsor's protocol ID
- 06-02-20-1
- Other IDs
- K24AT002422
- Status last verified
- May 2016
- First submitted
- 13 Apr 2006
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
PubMed 16080794Licciardone JC, King HH, Hensel KL, Williams DG. OSTEOPAThic Health outcomes in chronic low back pain: The OSTEOPATHIC Trial. Osteopath Med Prim Care. 2008 Apr 25;2:5. doi: 10.1186/1750-4732-2-5.
PubMed 18439282Clinical Guideline Subcommittee on Low Back Pain; American Osteopathic Association. American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain. J Am Osteopath Assoc. 2010 Nov;110(11):653-66.
PubMed 21135197Licciardone JC, Gatchel R, Dagenais S. Assessment and management of back pain. JAMA Intern Med. 2014 Mar;174(3):478-9. doi: 10.1001/jamainternmed.2013.13692. No abstract available.
PubMed 24590092Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available.
PubMed 24133757Licciardone JC. Systematic review and meta-analysis conclusions relating to osteopathic manipulative treatment for low back pain remain valid and well accepted. J Bodyw Mov Ther. 2013 Jan;17(1):2-4. doi: 10.1016/j.jbmt.2012.10.003. Epub 2012 Nov 16. No abstract available.
PubMed 23294676Licciardone JC. Osteopathic manipulative treatment in patients with low back pain. Clin Rheumatol. 2011 Jun;30(6):871-2; author reply 873. doi: 10.1007/s10067-011-1739-9. Epub 2011 Apr 15. No abstract available.
PubMed 21494808Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.
PubMed 23759340Licciardone JC, Kearns CM, Hodge LM, Minotti DE. Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2013 Jun;113(6):468-78.
PubMed 23739758Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.
PubMed 23508598Licciardone JC, Gatchel RJ, Kearns CM, Minotti DE. Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Dec;112(12):783-91.
PubMed 23212429Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
PubMed 22984233Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8.
PubMed 22802542Licciardone JC. Short-term dosing of manual therapies for chronic low back pain. Spine J. 2014 Jun 1;14(6):1085-6. doi: 10.1016/j.spinee.2013.12.015. Epub 2013 Dec 20. No abstract available.
PubMed 24361999Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18.
PubMed 24704126
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00315120
- Acronym / sponsor ID
- 06-02-20-1
- Conditions
- Low Back Pain
- Keywords
- Randomized controlled trial, Low back pain, Spinal manipulative therapy, Spinal manipulation, Osteopathic manipulation, Osteopathic medicine, Physical therapy modalities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Osteopathic Heritage Foundations, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Posted 6 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.
Detailed description
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A (Active OMT and active (UST) | Other | Procedure: A. Active OMT and active USTSubjects in this group received active osteopathic manipulation and active ultrasound physical therapy |
| B (Sham OMT and active UST) | Other | Procedure: B. Sham OMT and active USTSubjects in this group received sham osteopathic manipulation and active ultrasound physical therapy |
| C (Active OMT and sham UST) | Other | Procedure: C. Active OMT and sham USTSubjects in this group received active osteopathic manipulation and sham ultrasound physical therapy |
| D (Sham OMT and sham UST) | Other | Procedure: D. Sham OMT and sham USTSubjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
- Must identify the low back as the primary site of pain
- Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
- Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)
Key exclusion criteria (10 listed)
- History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
- History of surgery involving the low back within the past year or planned low back surgery in the future
- History of receiving Workers' Compensation benefits within the past three months
- Involvement in current litigation relating to back problems
- Current pregnancy or plan to become pregnant during the course of participation in the study
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 |
|---|---|---|
| A. Active OMT and active USTActive osteopathic manipulation (OMT) and active ultrasound physical therapy (UST) | Procedure or surgery | A (Active OMT and active (UST) |
| B. Sham OMT and active USTSham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST) | Procedure or surgery | B (Sham OMT and active UST) |
| C. Active OMT and sham USTActive osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST) | Procedure or surgery | C (Active OMT and sham UST) |
| D. Sham OMT and sham USTSham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST) | Procedure or surgery | D (Sham OMT and sham UST) |
Primary outcome
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
Time frame: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)
Time frame: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
24 secondary outcomes
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)
Time frame: 4 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)
Time frame: 8 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)
Time frame: 12 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)
Time frame: 4 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)
Time frame: 8 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)
Time frame: 12 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)
Time frame: 4 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)
Time frame: 8 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)
Time frame: 12 weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)
Time frame: 4 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)
Time frame: 8 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)
Time frame: 12 Weeks
Work Disability (OMT and Sham OMT - Week 4)
Time frame: 4 weeks
Work Disability (OMT and Sham OMT - Week 8)
Time frame: 8 weeks
Work Disability (OMT and Sham OMT - Week 12)
Time frame: 12 weeks
Work Disability (UST and Sham UST - Week 4)
Time frame: 4 weeks
Work Disability (UST and Sham UST - Week 8)
Time frame: 8 weeks
Work Disability (UST and Sham UST - Week 12)
Time frame: 12 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 4)
Time frame: 4 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 8)
Time frame: 8 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 12)
Time frame: 12 weeks
Satisfaction With Back Care (UST and Sham UST - Week 4)
Time frame: 4 weeks
Satisfaction With Back Care (UST and Sham UST - Week 8)
Time frame: 8 weeks
Satisfaction With Back Care (UST and Sham UST - Week 12)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16080794Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
- Background: PubMed 18439282Licciardone JC, King HH, Hensel KL, Williams DG. OSTEOPAThic Health outcomes in chronic low back pain: The OSTEOPATHIC Trial. Osteopath Med Prim Care. 2008 Apr 25;2:5. doi: 10.1186/1750-4732-2-5.
- Background: PubMed 21135197Clinical Guideline Subcommittee on Low Back Pain; American Osteopathic Association. American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain. J Am Osteopath Assoc. 2010 Nov;110(11):653-66.
- Background: PubMed 24590092Licciardone JC, Gatchel R, Dagenais S. Assessment and management of back pain. JAMA Intern Med. 2014 Mar;174(3):478-9. doi: 10.1001/jamainternmed.2013.13692. No abstract available.
- Background: PubMed 24133757Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available.
- Background: PubMed 23294676Licciardone JC. Systematic review and meta-analysis conclusions relating to osteopathic manipulative treatment for low back pain remain valid and well accepted. J Bodyw Mov Ther. 2013 Jan;17(1):2-4. doi: 10.1016/j.jbmt.2012.10.003. Epub 2012 Nov 16. No abstract available.
- Background: PubMed 21494808Licciardone JC. Osteopathic manipulative treatment in patients with low back pain. Clin Rheumatol. 2011 Jun;30(6):871-2; author reply 873. doi: 10.1007/s10067-011-1739-9. Epub 2011 Apr 15. No abstract available.
- Results publication: PubMed 23759340Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.
- Results publication: PubMed 23739758Licciardone JC, Kearns CM, Hodge LM, Minotti DE. Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2013 Jun;113(6):468-78.
- Results publication: PubMed 23508598Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.
- Results publication: PubMed 23212429Licciardone JC, Gatchel RJ, Kearns CM, Minotti DE. Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Dec;112(12):783-91.
- Results publication: PubMed 22984233Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
- Individual participant dataSharing planned: No
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Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
John C. Licciardone, DO, MS, MBA principal investigator
The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A. Active OMT and active UST in people with Low Back Pain, run by University of North Texas Health Science Center 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 4 inclusion and 10 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 6 Jul 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315120, which also lists 19 linked publications.
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 6 Jul 2016.