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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Osteopathic Manual Treatment (OMT) is a system of hands-on techniques used by osteopathic physicians to increase function and reduce pain.
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.
University of North Texas Health Science Center
Fort Worth, Texas, United States
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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