Osteopathic Manipulative Treatment in Oncology Patients' Management

NCT ID: NCT03142386

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

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.

Detailed Description

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Conditions

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Geriatric Oncology Osteopathy in Other Diseases Classified Elsewhere

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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OMT group

Osteopathic manipulative treatment

Group Type EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type OTHER

Control Group

Physiotherapy

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

Interventions

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Osteopathic manipulative treatment

Intervention Type OTHER

Physiotherapy

Intervention Type OTHER

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Chiara Arienti

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chiara Arienti, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Don Gnocchi Foundation

References

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Arienti C, Bosisio T, Ratti S, Miglioli R, Negrini S. Osteopathic Manipulative Treatment Effect on Pain Relief and Quality of Life in Oncology Geriatric Patients: A Nonrandomized Controlled Clinical Trial. Integr Cancer Ther. 2018 Dec;17(4):1163-1171. doi: 10.1177/1534735418796954. Epub 2018 Aug 31.

Reference Type DERIVED
PMID: 30168356 (View on PubMed)

Other Identifiers

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Oncology and Osteopathy

Identifier Type: -

Identifier Source: org_study_id

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