Francesca Galiano
26/09/2022 - Last update 28/12/2022

John C. Licciardone, Cathleen M. Kearns, Lisa M. Hodge, Dennis E. Minotti | Year 2013

Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain


Chronic low back pain in cases of diabetes

Type of study:

Randomized controlled trial

Date of publication of the study’:



Purpose of the study

  • Objective: to evaluate the efficacy of OMT on chronic low back pain in people with diabetes mellitus
  • Measured outcomes:
    • primary: pain according to Visual Analog Scale (VAS) of 100mm
    • secondary: serum levels of TNF-α


  • Number: 68 people (52 female and 16 male)
  • Criteria of inclusion: people recruited in the OSTEOPAThic Trial with diabetes mellitus (through a questionnaire completed by them and not through a clinical diagnosis).
    • Criteria of inclusion in the OSTEOPAThic Trial: age 21-69 years, nonspecific low back pain for most of the time in the passed 3 months, pain localized mainly at lumbar level, not being pregnant and not having planned to become pregnant throughout the study.
  • Criteria of exclusion:presence of “red flags” for low back pain, recent lumbar surgery, receipt of work compensations over the past 3 months, ongoing controversies regarding the low back pain, medical condition preventing the reception of OMT or ultrasound therapy, use of corticosteroids in the past month, to be a manual therapist or a student in manual therapies, clinical signs of lumbar radiculopathy such as: weakness in the dorsiflexion of the ankle and in the extension of the big toe, altered reflexes in the ankle, loss of perception of delicate touch in the medial, dorsal and lateral contours of the foot, excruciating pain in the back of the leg, pain in the ipsilateral or contralateral foot in the case of straight-leg raising. straight-leg raising.
  • Groups of study: 4 groups obtained by randomization
    • Group 1: OMT and ultrasound therapy
    • Group 2: sham OMT and ultrasound therapy
    • Group 3: OMT and sham ultrasound therapy
    • Group 4: sham OMT and sham ultrasound therapy
    • On the basis of the treatments received the groups can be seen as:
      • OMT group, 19 people (16 female and 3 male, mean age 51 years)
      • Sham OMT group, 15 people (10 female and 5 male, mean age 55 years)
      • Ultrasound therapy group, 17 people (13 female and 4 male, mean age 54 years)
      • Sham ultrasound therapy group, 17 people (13 female and 4 male, mean age 51 years)

Interventions and evaluations

  • Before randomization, assessment of possible somatic dysfunctions through osteopathic SOAP note form
  • Before and after the study, pain evaluation through VAS from 0 to 100mm
  • 30 minutes before the first treatment and 4 weeks after the last one, evaluation of serum levels of cytokines such as IL-1β, IL-6, IL-8, IL-10 e TNF-α
  • 15-minutes sessions of OMT and sahm OMT at the beginning of the study and on weeks 1, 2, 4, 6 and 8
  • OMT: six commonly used techniques directed to the lumbosacral, iliac and pubic regions
  • Sham OMT: applied on the same areas as the OMT but without directly involving the areas affected by the somatic dysfunctions
    Ultrasound therapy
  • Sham ultrasound therapy: use of a subtherapeutic intensity
  • OMT performed by specialized osteopaths, residents or pre-PhD students


  • Primary outcomes: Over the 12 weeks of the study low back pain decreased in a statistically significant manner in the OMT group compared to baseline (-20mm on the VAS scale, on average), but not in the sham OMT group. Consequently, the OMT group reported a decisively greater and statistically significant decrease in lumbar pain than the group with sham OMT (-20mm vs -3mm), thus defining a moderate effect size (the relevance of the effect obtained).
    Between the ultrasound and sham ultrasound therapy groups no statistically significant difference was found.
  • Secondary outcomes: the levels of TNF-α were measured in 6 people (4 in the OMT group and 2 in the sham OMT group). The OMT favored a statistically significant reduction in serum concentration of TNF-α, as opposed to sham OMT, defining a high effect size.
    No statistically significant difference was detected between the groups with ultrasound and sham ultrasound therapies.
  • Further analyses: the reduction of TNF-α resulted correlated to the decrease in lumbar pain, although not in a statistically significant way.


OMT was able to reduce statistically significantly low back pain in people with diabetes, who, compared to the general population of the OSTEOPAThic Trial, presented a higher number of somatic dysfunctions and of higher severity. In this regard, solving somatic dysfunctions can be particularly useful in diabetic people, much more than in non-diabetic people.

However, studies with a higher number of people are needed to avoid the influence of possible confounding factors and to better separate the influence of OMT and ultrasound therapy.

The review of Osteopedia

By Marco Chiera

Strengths: interesting results given the entity of the low back pain reduction as well as the reduction of TNF-α, a molecule that can induce molecola che può indurre insulin-resistance (Therefore, OMT could theoretically also help to better manage blood sugar concentration, but studies more extensive and specifically focused on diabetes are needed).

Limits: too small a sample to generalize the results, especially to define the connection between the reduction of TNF-α and low back pain.

Are you an osteopath?

Register and enjoy the membership benefits. Create your public profile and publish your studies. It's free!

Register now

School or training institution?

Register and enjoy the membership benefits. Create your public profile and publish your studies. It's free!

Register now

Do you want to become an osteopath? Are you a student?

Register and enjoy the membership benefits. Create your public profile and publish your studies. It's free!

Register now