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NCT02054650 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of North Texas Health Science Center.

Terminated
Registry status
NA
Development phase
23
Enrollment target

NCT02054650: Clinical Trial NA study, sponsored by University of North Texas Health Science Center.

NCT02054650 is a NA study that was terminated before completion, run by University of North Texas Health Science Center. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02054650, a NA study, was terminated before completion, sponsored by University of North Texas Health Science Center.

TERMINATED
Registry status
NA
Development phase
23 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Osteopathic Manual Treatment (OMT)
  • OTHER Sham OMT

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2014-05
Est. Completion 2015-08
Phase NA

Why NCT02054650 stopped before completion

NCT02054650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Osteopathic Manual Treatment (OMT) is the first listed.

NCT02054650 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02054650 about?

NCT02054650 is a clinical study titled "OMT 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...

What is the current status of trial NCT02054650?

This trial is currently terminated. It is a NA study. The enrollment target is 23 participants. The study started on 2014-05. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02054650?

The interventions under investigation include: Osteopathic Manual Treatment (OMT) (OTHER), Sham OMT (OTHER).

Who is sponsoring clinical trial NCT02054650?

This trial is sponsored by University of North Texas Health Science Center, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02054650's enrollment target sits among peer trials

23 1755th of 2000 higher than 245 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02054650, the US trial registry maintained by the National Library of Medicine. NCT02054650 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.