Back to results

OMT of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Chronic Low Back Pain, Type 2 Diabetes Mellitus

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Osteopathic Manual Treatment (OMT)

Sham OMT

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Type 2 diabetes mellitus, Back pain, Diabetes, Osteopathic manual treatment, Osteopathic manipulative treatment, OMT, Biomarkers, Glycemic control, Kidney function

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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).

Sites / Locations

University of North Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Osteopathic Manual Treatment (OMT)

Sham OMT

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02054650

First Posted

January 31, 2014

Last Updated

May 24, 2016

Sponsor

University of North Texas Health Science Center

Collaborators

American Osteopathic Association, Osteopathic Heritage Foundations

1. Study Identification

Unique Protocol Identification Number

NCT02054650

Brief Title

OMT of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus

Official Title

Osteopathic Manipulative Treatment of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Scheduling and recruitment difficulties

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Texas Health Science Center

Collaborators

American Osteopathic Association, Osteopathic Heritage Foundations

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Glycemic control, Kidney function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Osteopathic Manual Treatment (OMT)

Arm Type

Experimental

Arm Description

Arm Title

Sham OMT

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Osteopathic Manual Treatment (OMT)

Intervention Description

Osteopathic Manual Treatment (OMT) is a system of hands-on techniques used by osteopathic physicians to increase function and reduce pain.

Intervention Type

Other

Intervention Name(s)

Sham OMT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in low back pain severity

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in back-specific functioning

Description

Time Frame

12 weeks

Title

Change in general health

Description

Time Frame

12 weeks

Title

Change in glycemic control

Description

Time Frame

12 weeks

Title

Tissue texture changes

Description

Time Frame

12 weeks

Title

Change in biomarker concentrations

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John C. Licciardone, DO, MS, MBA

Organizational Affiliation

University of North Texas Health Science Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Texas Health Science Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23739758

Citation

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.

Results Reference

background

PubMed Identifier

23759340

Citation

Licciardone 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 Reference

background

PubMed Identifier

23508598

Citation

Licciardone 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 Reference

background

PubMed Identifier

22984233

Citation

Licciardone 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. Erratum In: J Am Osteopath Assoc. 2017 Jun 1;117(6):350.

Results Reference

background

PubMed Identifier

22802542

Citation

Licciardone 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.

Results Reference

background

PubMed Identifier

23212429

Citation

Licciardone 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 Reference

background

PubMed Identifier

17371582

Citation

Licciardone 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.

Results Reference

background

Learn more about this trial

OMT of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs