NCT Number: NCT03142386
Osteopathic Manipulative Treatment in Oncology Patients' Management
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.
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Notify MeKey information
Conditions
Age range
65 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Physiotherapy
OtherPrimary outcomes
-
Pain
Time frame: Once a week for a total 4 weeks
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.
Secondary outcomes
-
Quality of life
Time frame: At baseline and up to 4 weeks.
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.
Sponsors and collaborators
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Other
Registry information
Official study title
Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- May 5, 2017
- Registry last updated
- May 5, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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