Osteopathic Manipulative Treatment in Oncology Patients' Management

• Sponsor: Fondazione Don Carlo Gnocchi Onlus (Other)
• Overall Status: Completed
• CT.gov ID: NCT03142386
• Collaborator: (none)
• Enrollment: 23
• Arms: 2
• Actual Duration (Months): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Geriatric Oncology; Osteopathy in Other Diseases Classified Elsewhere	Other: Osteopathic manipulative treatment; Other: Physiotherapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OMT group Osteopathic manipulative treatment	Other: Osteopathic manipulative treatment
Active Comparator: Control Group Physiotherapy	Other: Physiotherapy

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fondazione Don Carlo Gnocchi Onlus

Investigators

• Principal Investigator: Chiara Arienti, PhD, IRCCS Don Gnocchi Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiara Arienti, PhD, Fondazione Don Carlo Gnocchi Onlus
• ClinicalTrials.gov Identifier: NCT03142386
• Other Study ID Numbers: Oncology and Osteopathy
• First Posted: May 5, 2017
• Last Update Posted: May 5, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chiara Arienti, PhD, Fondazione Don Carlo Gnocchi Onlus: geriatric oncology; pain; osteopathic manipulative treatment; quality of life
• Additional relevant MeSH terms: Neoplasms; Disease

Study Results

No Results Posted as of May 5, 2017