Francesca Galiano
|
09/08/2022 - Last update 30/12/2022
Chiara Arienti, Teresa Bosisio, Silvia Ratti, Rossella Miglioli, Stefano Negrini | Year 2018
Osteopathic Manipulative Treatment Effect on Pain Relief and Quality of Life in Oncology Geriatric Patients, A Nonrandomized Controlled Clinical Trial
Pathology:
Neoplasms
Type of study:
Non randomized controlled trial (as a pilot study)
Date of publication of the study’:
2018/Dec/17
Purpose of the study
- Objective: to evaluate the effects of ’OMT pain and quality of life in hospitalized oncology geriatric patients
- Measured outcomes:
• primary: change in perceived pain measured with the Numeric Rating Scale (NRS)
• secondary: change in quality of life measured using the following scales, Global Health Status (GHS), Financial Difficulty (FD) and Summary Score (SS) of the questionnaireEuropean Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQC30); adverse effects
Participants
- Number: 23 people (14 female and 9 male)
- Criteria of inclusion: age > 65 years, postsurgical oncology patients, prognosis of 6 to 24 months, chronic pain for at least 3 months with an intensity score higher than 3 on the NRS.
- Criteria f exclusion: patients receiving chemotherapy or radiotherapy at the time of the study, with mental disorders (evaluated with Mini-Mental State Examination questionnaire with a score between 10 and 20), with infections, anticoagulation therapy, cardiopulmonary diseases, clinical instability postsurgery.
- Group of study: two non randomized groups
- Group 1: physiotherapy with the addition of OMT (7 female and 5 male, average age 76.5 years)
- Group 2: physiotherapy, 12 people (7 female and 4 male, average age 76.5 yearsi)
- 1 person dropped out after the first intervention
- Main tumores: colonrectal, osteosarcoma, spinal metastasis from breast and prostate cancer, and kidney cancer
- At the beginning of the study group 1 had a level of pain higher compared to group 2 (6.08±3.40 compared to 3.36±2.20)
Interventions and evaluations
- Evaluation of quality of life through the GHS, FD, SS scales and QLQC30 questionnaire at beginning and at end of the study (after 4 weeks)
- Evaluation of the pain through NRS at the beginning of the study, after 1, 2 and 3 weeks and at the end of the study (after 4 weeks)
- 30-minutes sessions of physiotherapy once a week
- 45-minute weekly sessions of OMT
- Physiotherapy: based on patients’ needs, passive mobilizations, active-assisted or active-resisted exercises, walking, proprioceptive neuromuscular facilitation applied on joints and painful muscles
- OMT:
- initial assessment through the application of the five models (biomechanical, neurological, metabolic, respiratory-circulatory and behavioral)
- treatment: soft tissues techniques at the cervical, dorsal and lumbar levels, rib lifting, abdominal, back and sacroiliac myofascial release, suboccipital decompression
- OMT was administered by the same osteopath with more than 10 years of clinical experience
- Patients were allowed to use nonsteroidal anti-inflammatory drugs (FANS) when needed
Results
- Primary outcomes: OMT added to physiotherapy showed a statistically significant reduction in pain both half way through the study (after 2 weeks) and at the end of the study (after 4 weeks), while the group with physiotherapy alone saw a statistically significant reduction in pain only at the end of the study.
- Secondary outcomes: OMT added to physiotherapy showed no improvement in quality of life, although there is a positive trend in the SS and GHS scales approaching statistical significance (p-value of 0.058 and 0.074, respectively) without reaching it. On the other hand, there seems to be a worsening in the FD scale.
Physiotherapy alone showed a statistically significant improvement in both the SS and GHS scales, while it did not induce any change in the FD scale.
Despite these results within the single groups, no statistically significant differences between groups were found.
No adverse effects emerged from the interventions.
Discussion
Both physiotherapy alone and OMT added to physiotherapy proved to be able to reduce pain and improve quality of life according to overall health status scales.
However, only OMT showed a statistically significant reduction in pain after 2 weeks, while physiotherapy alone showed this result only at the end of the 4 weeks of the study. On the other hand, physiotherapy alone has significantly improved quality of life.
The reasons for this last discrepancy on quality of life may derive from the non-appropriateness of QLQC30 for a population of elderly patients who may have had difficulties in completing the questionnaire at best, consequently invalidating the results of the study.
On the other hand, the positive result that OMT had on pain is added to those of other studies that had already reported similar effects in different pathological conditions. The reason for this can lie in the mind-body individualized approach that derives from the individualized application of the principles defining osteopathic practice to each patient.
Given the exploratory nature of the study, the authors hope for broader studies, where the overall health status of elderly patients would also be assessed, perhaps through the Comprehensive Geriatric Assessment.
The review of Osteopedia
By Marco Chiera
Strengths: appropriate statistical analyses (although some tests could have been chosen differently), despite the missing data for the patient who left the study, and taking into account the intention to reduce the risk of a false negative, given the exploratory nature of the study.
Regardless of the statistical values, the reduction of pain and the increase in quality of life seem significant also from a clinical point of view – reduction from 35% to 57% of the NRS score and increase of 5-10 points in the QLQC30 scales – and, therefore, to be really taken into account to improve health policy.
Limits: for a better interpretation of the results it might have been better to compare the OMT alone with physiotherapy alone, or to form 3 groups (physiotherapy only, OMT only, physiotherapy with OMT); the use of NSAIDs was not taken into account in the analysis; differences in pain reduction after 2 weeks may have resulted from a higher pain level in group 1.
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