Chronic Low Back PainNCT02054650
OMT of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus
A study testing Osteopathic Manual Treatment (OMT) in people with Chronic Low Back Pain and Type 2 Diabetes Mellitus, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit; 2) the body has inherent self-regulatory mechanisms; 3) structure and function are interrelated; and 4) rational treatment is based on an understanding and integration of these concepts. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Low Back Pain, Type 2 Diabetes Mellitus
- What is being tested?
- Osteopathic Manual Treatment (OMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose ≥126 mg/dL; OR
- Oral glucose tolerance test ≥200 mg/dL; OR
- HbA1c ≥6.5%
- AND
- Low back pain on most days for past three months; AND
- Usual low back pain severity of 4 or greater on an 11 point numerical scale during the past week.
Who cannot join
- age less than 18 years or age greater than 79 years; OR
- having a previous or current diagnosis of type 1 diabetes mellitus; OR
- having a history of any of the following pancreatic or related disorders: (a) acute or chronic pancreatitis, (b) pancreatic tumor or cancer, (c) Zollinger-Ellison syndrome, or (d) any other medical or surgical condition resulting in functional hypo- or hyperglycemia; OR
- having end-stage renal disease; OR
- having a history of any surgery involving the pancreas; OR
- having a history of low back surgery in the past year; OR
Show all 19Show fewer
- receiving workers' compensation benefits in the past three months; OR
- having involvement in ongoing litigation relating to diabetes mellitus or back problems; OR
- having a history of a stroke or transient ischemic attack in the past year; OR
- having used intravenous, intramuscular or oral corticosteroids within the past month; OR
- attending a manual treatment session (OMT or any manual therapies delivered by chiropractors or physical therapists) in the past three months, or more than three times in the past year; OR
- practicing osteopathic medicine, chiropractic, or physical therapy, or attending a corresponding professional school; OR
- being pregnant; OR
- currently participating in another medical research study
- Subjects will also be excluded if any of the following conditions are found during the clinical screening:
- presence of "red flag" conditions relating to LBP (cancer at any anatomical site, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, or cauda equina syndrome); OR
- angina or congestive heart failure symptoms with minimal activity; OR
- active bleeding or infection in the lower back, or any other condition that might impede protocol implementation; OR
- discovery of the presence of any telephone screening exclusion criterion (EXCEPT that the usual LBP severity over the past week may have declined from ≥4/10 points to ≥3/10 points during the lag time between screenings).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: Osteopathic Manipulative Treatment of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus
The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit; 2) the body has inherent self-regulatory mechanisms; 3) structure and function are interrelated; and 4) rational treatment is based on an understanding and integration of these concepts. Patients with type 2 diabetes mellitus often report more aches and pains than people without diabetes. Because osteopathic manual medicine addresses dysfunction in the musculoskeletal system, patients with both chronic low back pain and type 2 diabetes mellitus may benefit from this non-pharmacological treatment to reduce their pain, thereby reducing their stress and perhaps providing better clinical control for diabetes as demonstrated by key markers such as hemoglobin A1c and kidney function. This study is an extension of research completed in the OSTEOPATHIC Trial. Results of that study were published in the Annals of Family Medicine in March/April 2013.
Read the detailed description
SPECIFIC AIM 1:
To conduct a randomized controlled trial (RCT) to determine the efficacy of osteopathic manual treatment (OMT) vs sham OMT in subjects with type 2 diabetes mellitus (T2DM) and comorbid chronic low back pain (LBP). This will involve a 12-week protocol to study changes in response to OMT in such outcomes as LBP severity (primary outcome measure), somatic dysfunction, renal function, glycemic control, and other biomarkers potentially related to T2DM.
SPECIFIC AIM 2:
Within the RCT, to corroborate previous findings indicating that patients with T2DM have a high prevalence of tissue texture abnormalities in the T11-L2 spinal segmental region and to determine if such findings can be statistically associated with the presence of diabetic nephropathy using such laboratory measures as serum creatinine, urinary microalbuminuria and macroalbuminuria, and the glomerular filtration rate.
SPECIFIC AIM 3:
Within the RCT, to explore potential mechanisms of action of OMT by longitudinally measuring concentrations of biomarkers such as insulin, glucagon, cortisol, hemoglobin A1c, tumor necrosis factor-α,interleukin (IL)-1β, IL-6, IL-10, and IL-18 in subjects with T2DM and comorbid chronic LBP over 12 weeks. Significant changes in biomarker concentrations may help explain the effects of OMT and whether such effects are mediated by changes in somatic dysfunction.
- Conditions
- Chronic Low Back Pain, Type 2 Diabetes Mellitus
- Being tested
- Osteopathic Manual Treatment (OMT), Sham OMT
- Keywords
- Chronic low back pain, Type 2 diabetes mellitus, Back pain, Diabetes, Osteopathic manual treatment, Osteopathic manipulative treatment, OMT, Biomarkers, Glycemic control, Kidney function
- Medical subject headings
- Diabetes Mellitus, Type 2, Back Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual Treatment (OMT)Other
Osteopathic Manual Treatment (OMT) is a system of hands-on techniques used by osteopathic physicians to increase function and reduce pain.
Sham OMTOther
Sham OMT involves hand contact, active and passive range of motion, and sham techniques that simulate OMT, but that utilize such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manual Treatment (OMT) | Experimental | The OMT protocol will be delivered following an examination for somatic dysfunction at each treatment session. The protocol will target the thoracic, lumbosacral, iliac, and pubic regions using the following techniques: high-velocity, low-amplitude thrusts; moderate-velocity, moderate-amplitude thrusts; soft tissue including stretching, kneading, and pressure; myofascial stretching and release; counterstrain; muscle energy; and other optional techniques as time permits and indicated. The intervention will be delivered at weeks 0, 1, 2, 4, 6 and 8. Week 12 is a data collection visit with no intervention. Receives: Other: Osteopathic Manual Treatment (OMT) |
| Sham OMT | Sham comparator | Sham OMT will involve hand contact, active and passive range of motion, and sham techniques that simulate OMT (including optional OMT techniques), but that utilize such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force. Sham OMT will be delivered at weeks 0, 1, 2, 4, 6 and 8. Week 12 is a data collection visit with no intervention. Receives: Other: Sham OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low back pain severity
The change in low back pain severity will be measured using an 11-point numerical scale (0 to 10). The baseline measurement for each subject will be compared with the week 12 measurement to determine if a reduction in pain has occurred.
Measured: 12 weeks
Secondary outcomes (5)
Change in back-specific functioning
The change in back-specific functioning will be measured using the Roland-Morris Disability Questionnaire (scored from 0 to 24). The baseline measurement for each subject will be compared with the week 12 measurement to determine if an improvement in back-specific functioning has occurred.
Measured: 12 weeks
Change in general health
The change in general health will be measured using the Short Form 36 Health Status Survey (scored from 0 to 100). The baseline measurement for each subject will be compared with the week 12 measurement to determine if an improvement in general health has occurred.
Measured: 12 weeks
Change in glycemic control
The change in glycemic control will be measured using hemoglobin A1C levels. The baseline measurement for each subject will be compared with the week 12 measurement to determine if an improvement in glycemic control has occurred.
Measured: 12 weeks
Tissue texture changes
The change in tissue texture will be assessed during physical examinations. The baseline findings for each subject will be compared with the week 12 findings to determine if a change in tissue texture has occurred.
Measured: 12 weeks
Change in biomarker concentrations
Concentrations of biomarkers such as insulin, glucagon, cortisol, TNF-α, IL-1β, IL-6, IL-10, and IL-18 will be measured at baseline and at week 12 to determine if any significant change in a biomarker has occurred.
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 posted4 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Scheduling and recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association, Osteopathic Heritage Foundations
- Responsible party
- Sponsor
- Investigators
- John C. Licciardone, DO, MS, MBA, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054650
- Sponsor's protocol ID
- 2013-127
- Other IDs
- 13-11-686
- Status last verified
- May 2016
- First submitted
- 31 Jan 2014
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Licciardone 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, 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, 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, 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, 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, Fulda KG, Stoll ST, Gamber RG, Cage AC. A case-control study of osteopathic palpatory findings in type 2 diabetes mellitus. Osteopath Med Prim Care. 2007 Feb 8;1:6. doi: 10.1186/1750-4732-1-6.
PubMed 17371582
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02054650
- Acronym / sponsor ID
- 2013-127
- Conditions
- Chronic Low Back Pain, Type 2 Diabetes Mellitus
- Keywords
- Chronic low back pain, Type 2 diabetes mellitus, Back pain, Diabetes, Osteopathic manual treatment, Osteopathic manipulative treatment, OMT, Biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Scheduling and recruitment difficulties
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- American Osteopathic Association, Osteopathic Heritage Foundations
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit; 2) the body has inherent self-regulatory mechanisms; 3) structure and function are interrelated; and 4) rational treatment is based on an understanding and integration of these concepts. Patients with type 2 diabetes mellitus often report more aches and pains than people without diabetes. Because osteopathic manual medicine addresses dysfunction in the musculoskeletal system, patients with both chronic low back pain and type 2 diabetes mellitus may benefit from this non-pharmacological treatment to reduce their pain, thereby reducing their stress and perhaps providing better clinical control for diabetes as demonstrated by key markers such as hemoglobin A1c and kidney function. This study is an extension of research completed in the OSTEOPATHIC Trial. Results of that study were published in the Annals of Family Medicine in March/April 2013.
Detailed description
SPECIFIC AIM 1:
To conduct a randomized controlled trial (RCT) to determine the efficacy of osteopathic manual treatment (OMT) vs sham OMT in subjects with type 2 diabetes mellitus (T2DM) and comorbid chronic low back pain (LBP). This will involve a 12-week protocol to study changes in response to OMT in such outcomes as LBP severity (primary outcome measure), somatic dysfunction, renal function, glycemic control, and other biomarkers potentially related to T2DM.
SPECIFIC AIM 2:
Within the RCT, to corroborate previous findings indicating that patients with T2DM have a high prevalence of tissue texture abnormalities in the T11-L2 spinal segmental region and to determine if such findings can be statistically associated with the presence of diabetic nephropathy using such laboratory measures as serum creatinine, urinary microalbuminuria and macroalbuminuria, and the glomerular filtration rate.
SPECIFIC AIM 3:
Within the RCT, to explore potential mechanisms of action of OMT by longitudinally measuring concentrations of biomarkers such as insulin, glucagon, cortisol, hemoglobin A1c, tumor necrosis factor-α,interleukin (IL)-1β, IL-6, IL-10, and IL-18 in subjects with T2DM and comorbid chronic LBP over 12 weeks. Significant changes in biomarker concentrations may help explain the effects of OMT and whether such effects are mediated by changes in somatic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manual Treatment (OMT) | Experimental | Other: Osteopathic Manual Treatment (OMT)The OMT protocol will be delivered following an examination for somatic dysfunction at each treatment session. The protocol will target the thoracic, lumbosacral, iliac, and pubic regions using the following techniques: high-velocity, low-amplitude thrusts; moderate-velocity, moderate-amplitude thrusts; soft tissue including stretching, kneading, and pressure; myofascial stretching and release; counterstrain; muscle energy; and other optional techniques as time permits and indicated. The intervention will be delivered at weeks 0, 1, 2, 4, 6 and 8. Week 12 is a data collection visit with no intervention. |
| Sham OMT | Sham comparator | Other: Sham OMTSham OMT will involve hand contact, active and passive range of motion, and sham techniques that simulate OMT (including optional OMT techniques), but that utilize such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force. Sham OMT will be delivered at weeks 0, 1, 2, 4, 6 and 8. Week 12 is a data collection visit with no intervention. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fasting plasma glucose ≥126 mg/dL; OR
- Oral glucose tolerance test ≥200 mg/dL; OR
- HbA1c ≥6.5%
- AND
- Low back pain on most days for past three months; AND
Key exclusion criteria (19 listed)
- age less than 18 years or age greater than 79 years; OR
- having a previous or current diagnosis of type 1 diabetes mellitus; OR
- having a history of any of the following pancreatic or related disorders: (a) acute or chronic pancreatitis, (b) pancreatic tumor or cancer, (c) Zollinger-Ellison syndrome, or (d) any other medical or surgical condition resulting in functional hypo- or hyperglycemia; OR
- having end-stage renal disease; OR
- having a history of any surgery involving the pancreas; OR
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 Manual Treatment (OMT)Osteopathic Manual Treatment (OMT) is a system of hands-on techniques used by osteopathic physicians to increase function and reduce pain. | Other | Osteopathic Manual Treatment (OMT) |
| Sham OMTSham OMT involves hand contact, active and passive range of motion, and sham techniques that simulate OMT, but that utilize such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force. | Other | Sham OMT |
Primary outcome
Change in low back pain severity
Time frame: 12 weeks
The change in low back pain severity will be measured using an 11-point numerical scale (0 to 10). The baseline measurement for each subject will be compared with the week 12 measurement to determine if a reduction in pain has occurred.
5 secondary outcomes
Change in back-specific functioning
Time frame: 12 weeks
Change in general health
Time frame: 12 weeks
Change in glycemic control
Time frame: 12 weeks
Tissue texture changes
Time frame: 12 weeks
Change in biomarker concentrations
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Scheduling and recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 22802542Licciardone 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.
- Background: 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.
- Background: PubMed 17371582Licciardone JC, Fulda KG, Stoll ST, Gamber RG, Cage AC. A case-control study of osteopathic palpatory findings in type 2 diabetes mellitus. Osteopath Med Prim Care. 2007 Feb 8;1:6. doi: 10.1186/1750-4732-1-6.
- Individual participant dataSharing planned: No
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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.
John C. Licciardone, DO, MS, MBA principal investigator
University of North Texas Health Science Center
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 Manual Treatment (OMT) in people with Chronic Low Back Pain and Type 2 Diabetes Mellitus, 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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 May 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Scheduling and recruitment difficulties). Results are not available in the source record.
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 low back pain severity (time frame: 12 weeks). 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 NCT02054650, which also lists 7 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 26 May 2016.