Francesca Galiano
|
12/09/2022 - Last update 29/12/2022

Giovanni C. Licciardone | Year 2021

Preventing progression from chronic to widespread pain and its impact on health-related quality of life, a historical cohort study

Pathology:

Chronic pain

Type of study:

Historical cohort study

Date of publication of the study’:

2021/Sep/23

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Purpose of the study

  • Objective: to evaluate if OMT can prevent the progression of low back pain from localized pain to chronic widespread pain and, therefore, reduce the impact of pain on quality of life
  • Measured outcomes:
    • Primary: assessment of the presence and intensity of chronic widespread pain through the Minimum Dataset for Chronic Low Back Pain questionnaire
    • Secondary: assessment of quality of life through Patient-Reported Outcomes Measurement Information System

Participants

  • Number: 462 people (336 female and 126 male)
  • Criteria of inclusion: included in the PRECISION Pain Research Registry, age 21-79 years, with chronic low back pain (low back pain for at least 3-6 months with a frequency of at least one-half of the days elapsed in the last 6 months), followed only by one physician, having completed all four quarterly follow-ups (12-months period)
  • Criteria of exclusion: having changed referring physician
  • Groups of study: 2 classifications based on the kind of physicians who were following the cases of the recruited people and on previous administration of OMT
    • 1st classification
      • Group 1: followed by osteopathic physicians, 101 people (77 female and 24 male, mean age 53.5 years)
      • Group 2: followed by allopathic physicians, 361 people (259 female and 102 male, mean age 52.4 years)
      • In group 1 more people have reported to have received spinal manipulation compared to group 2
    • 2nd classificazione
      • Group 1: have never received OMT, 210 people
      • Group 2: have maybe received OMT and have been followed by an allopathic physician, 179 people
      • Group 3: have received OMT and have been followed by an osteopathic physician, 73 people

Interventions and evaluations

  • The participants were followed for 12 months (initial visit and 4 quarterly follow-ups)
  • Data collection concerning ethnicity, level of education, habits, comorbidities, previous surgeries, use of other non pharmacologic therapies (eg, acupuncture) and use of medications
  • At the beginning of the study and at each follow-up assessment of the presence of chronic widespread pain using the Minimum Dataset for Chronic Low Back Pain questionnaire
    • participants who reported “not being bothered at all” by such a pain were classified as free from widespread pain
    • the intensity of widespread pain was assessed adding up the responses obtained overtime
  • At the beginning of the study and at each follow-up, assessment of quality of life through Patient-Reported Outcomes Measurement Information System
    • the scores related to physical function, anxiety, depression, fatigue, sleep disorders, participation in social role and activities and pain interference with activities were all assessed

Results

  • Primary outcomes: the participants followed by an osteopath reported a lesser widespread pain compared to the participants followed by an allopathic physician in a statistically significant manner (76.2% vs 87.3%). These results remained unchanged also after having adjusted the analysis for possible confounding factors (age, sex, etc.).
    With regard to the presence of widespread pain on the basis of having received OMT or not, people who had received OMT showed, statistically significantly, a lower presence of widespread pain than those who had never received it (71.2% vs 88.8%) but this result changed once the analysis was adjusted considering all confounding factors. On the other hand, participants who might have received OMT did not differ from those who had never received it.
    With regards to intensity of pain, the group followed by osteopaths reported a lower intensity compared to the group followed by allopathic physicians, with statistically significant results, as well as those who had received OMT reported a lower intensity compared to those who might have received it and those who had never received it.
  • Secondary outcomes: the group followed by osteopaths reported a better quality of life on all different scales than the group followed by allopathic doctors – statistically significant result. In addition, the improvement was clinically significant for the following scales: physical function, anxiety, depression, sleep disturbances, participation in social roles and activities, pain interference with activities.
    Likewise, participants who received OMT, compared to those who had never received it, reported a statistically and clinically significant improvement in the following scales: physical function, anxiety, depression, sleep disturbances, participation in social roles and activities, pain interference with activities.
    In both comparisons, only the fatigue score improved without a statistical significance.
    On the other hand, the group that might have used OMT did not show any improvements compared to the group that had never used it.

Discussion

Being followed by an osteopathic physician and/or having received OMT over 12 months emerged as a protective factor in the progression of low back pain from localized to widespread to the rest of the body. In fact, both the presence of widespread pain and its intensity were lower than those who never received OMT and/or were followed by an allopathic doctor.

The reason, most likely, lies in the characteristic holistic approach of osteopathy, therefore: on the one hand, the whole body is always considered according to the biopsychosocial paradigm and not simply the anatomically localized pain; on the other hand, there is a greater tendency to define an empathic relationship with the patient which favores their empowerment and hope.

These hypotheses can be confirmed by the result obtained in quality of life, improved in all subscales except for fatigue. These subscales also contemplated aspects such as mood (anxiety and depression) or insomnia, besides assessing how much pain interfered with daily activities.

A strong point of the study was definitely the use of a digital registry in which data from the United States of North America were collected. However, it may be useful to implement evaluation cards in order to add them to those used, to better recognize the occurrence of all specific pathologies (eg, fibromyalgia).

The review of Osteopedia

By Marco Chiera

Strengths: use of data collected directly from the clinic and, therefore, more generalizable compared to a RCT (certainly more rigorous, but often far from daily clinical practice); multiple confounding factors were considered in the analysis to detect the actual effect of OMT; accurate description of the method and of statistical analysis.

Limits:it would have been interesting to also collect the patients’ qualitative evaluation, that is, the patients’ experience of the two groups (osteopathic physicians vs allopathic physician) in order to understand if the result is actually related to the OMT holistic approach, to the therapeutic relation, to the use of more effective techniques or other.

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