Osteopathic Manipulative Treatment in Oncology Patients' Management

Study Overview
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Brief Summary
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The aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. A non-randomized comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (OMT group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. All patients were revaluated at the end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain intensity. Standard level of significance was p<0.05.

Official Title
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Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study

Conditions
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Geriatric Oncology, Osteopathy in Other Diseases Classified Elsewhere

Intervention / Treatment
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* Other: Osteopathic manipulative treatment
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: oncology patients male and female age≥65 years with a clinical prognosis of 6-24 months diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery) pain intensity score higher than 3, measured with Numeric Rating Scale (NRS) Exclusion Criteria: patients were receiving chemotherapy or radiotherapy treatment at the time of the study with mental disorders (MMSE<10) the presence of infection anticoagulation therapy cardiopulmonary disease clinical instability post-surgery.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMT group<br>Osteopathic manipulative treatment | Other: Osteopathic manipulative treatment<br> <br> |
| Active Comparator: Control Group<br>Physiotherapy | Other: Physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Numeric Rating Scale (NRS) is a validated scale to measure the intensity of pain, with numbers between 0 and 10, with 0 representing absence of pain and 10 the worst possible pain experienced by the patient. | Once a week for a total 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQC30) is a validated multidimensional health-related quality of life (HRQOL) questionnaire composed of six functional scales, three symptom scales, and several additional single item scales. | At baseline and up to 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric oncology, pain, osteopathic manipulative treatment, quality of life