Osteopathic Manipulative Treatment in Oncology Patients' Management

Geriatric Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142386
• Other study ID #: Oncology and Osteopathy
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: May 3, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2017
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Geriatric Oncology
• Neoplasms
• Osteopathy in Other Diseases Classified Elsewhere

Intervention

Other:
• Osteopathic manipulative treatment

• Physiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.