Osteopathic Manipulative Treatment in Oncology Patients' Management

Not Applicable

Completed

• Conditions: Geriatric Oncology; Osteopathy in Other Diseases Classified Elsewhere
• Interventions: Other: Osteopathic manipulative treatment; Other: Physiotherapy

• Registration Number: NCT03142386
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Study First Submitted: 2017-04-28
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT group	Osteopathic manipulative treatment	Osteopathic manipulative treatment
Control Group	Physiotherapy	Physiotherapy

Primary Outcome Measures

Name	Time	Method
Pain	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 Outcome Measures

Name	Time	Method
Quality of life	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.