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Completed

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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Key information

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

Osteopathic manipulative treatment

Other

Physiotherapy

Other

Primary outcomes

  1. 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

  1. 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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