Francesca Galiano
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09/08/2022 - Last update 30/12/2022

Liria Papa, Alfonso Mandara, Michele Bottali, Vincenzo Gulisano, Stefano Orfei | Year 2012

A RCT on the effectiveness of osteopathic manipulative treatment in reducing pain and improving the quality of life in elderly patients affected by osteoporosis

Pathology:

Osteoporosis

Type of study:

Randomized controlled trial

Date of publication of the study’:

2012/Sep/09

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Purpose of the study

  • Objective: to evaluate the effects of OMT on pain and quality of life in elderly people affected by osteoporosis
  • Measured outcomes:
    • Primary: quality of life measured according to Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO -41) and bodily pain through Visual Analog Scale (VAS) from 1 to 10

Participants

  • Number: 72 people (51 female and 21 male)
  • Criteria of inclusion: 60 to 90 years of age, presence of osteopenia or osteoporosis
  • Criteria of exclusion: excessive loss of bone density (T-score – 7), presence of fractures
  • Group of study: 2 groups obtained through randomization
    • Group 1: OMT, 37 people (26 female and 11 male, average age 77.2 years)
    • Group 2: sham treatment, 35 people (25 female and 10 male, average age 76.6 years)

Interventions and evaluations

  • Evaluation of pain through VAS at the beginning of the first and last intervention session
  • Evaluation of quality of life through QUALEFFO -41 at the beginning of the first and last intervention session
    • the questionnaire QUALEFFO -41 evaluates aspects such as pain, health perception, mood, daily activities, household cleaning, leisure and mobility
  • 6 30-minutes sessions of OMT or sham treatment
  • OMT: blackbox treatment according to 3 criteria, namely, respect for the patient and their pain, execution of postural evaluation to discover the cause of pain and functional limitations, and use of different techniques, chosen on the basis of the patients’ evaluation and customized on the treated single individuals
  • Sham treatment: postural evaluation and palpation of nonspecific parts of the body in variable supine positions

Results

Primary outcomes: Neither the OMT nor the sham treatment showed effects on pain as measured by VAS. Regarding the quality of life, compared to the sham treatment (which showed no effect), OMT favored a statistically significant reduction in the total score obtained with QUALEFFO -41 between the beginning and the end of the study. Among the subscales analyzed, the OMT has statistically significantly favored a reduction in pain, an improvement in the perception of health and better mobility. The mood also improved, although not statistically significantly (p-value=0.06).

Discussion

Compared to sham treatment, OMT has led to an improvement, at least in the short term, in the quality of life of elderly people with osteoporosis.

This improvement seems due to both a better perception of one’s own health and a decrease in pain, a decrease probably more qualitative than quantitative (VAS, which measures only the pain intensity, has not, in fact, shown changes. However, it may also be that VAS was not the best tool to use in this study, especially as some people have struggled to understand how to use it). Whatsmore, the pain seems to have particularly decreased at the level of the spine, confirming other studies that see OMT useful in the treatment, for example, of low back pain.

It is not possible to know whether the effects will persist but, given the pilot nature of this study, these results must be the starting point for larger, more rigorous and long-lasting future studies.

The review of Osteopedia

By Marco Chiera

Strengths: evaluation of the OMT as a black-box, and therefore similar to daily clinical practice; “simple”, in the sense that few and precise validated outcomes were measured; pain was evaluated not only quantitatively but also qualitatively; the reasons why a certain number of people (additional to the 72 indicated) have not completed the study have been explained.

Limits: there are some typos (one figure, with related caption, is wrong) that prevent the complete comprehension of some passages of the study; there is not a minimal clinically important difference (MCID) for the QUALEFFO -41, it is unclear whether the results obtained have actual clinical repercussions on the health and quality of life of people.

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