NCT02054650

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

January 31, 2014

Last Update Submit

May 24, 2016

Conditions

Chronic Low Back PainType 2 Diabetes Mellitus

Keywords

Chronic low back painType 2 diabetes mellitusBack painDiabetesOsteopathic manual treatmentOsteopathic manipulative treatmentOMTBiomarkersGlycemic controlKidney function

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (5)

  • Change in back-specific functioning

    12 weeks

  • Change in general health

    12 weeks

  • Change in glycemic control

    12 weeks

  • Tissue texture changes

    12 weeks

  • Change in biomarker concentrations

    12 weeks

Study Arms (2)

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.

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.

Other: Sham OMT

Interventions

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.

Osteopathic Manual Treatment (OMT)
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.

Sham OMT

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (7)

  • 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.

    PMID: 23739758BACKGROUND

  • 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.

    PMID: 23759340BACKGROUND

  • 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.

    PMID: 23508598BACKGROUND

  • 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.

    PMID: 22984233BACKGROUND

  • 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.

    PMID: 22802542BACKGROUND

  • 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.

    PMID: 23212429BACKGROUND

  • 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.

    PMID: 17371582BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Back PainDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John C. Licciardone, DO, MS, MBA

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 4, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 26, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)