Shiatsu Adjuvant Therapy For Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00425399
First received: January 22, 2007
Last updated: May 21, 2014
Last verified: February 2009
  Purpose

In the current study we will study the effect of adding shiatsu treatment to conventional therapy in work with hospitalized schizophrenic patients.

The hypotheses of this study are several:

  1. Shiatsu can improve the patients' symptoms
  2. Shiatsu can ameliorate neuromuscular side effects produced by standard anti-psychotic treatment
  3. Shiatsu can provide patients with tools to deal with the stresses of their illness

2. Methodology We propose an open pilot study in which a total of 20 patients of both sexes will be enrolled. These patients will be drawn from the inpatient psychiatric wards at Herzog Hospital.

Upon inclusion into the trial, all participants will receive shiatsu treatment, consisting of two individual weekly 40-minute shiatsu treatment sessions for four weeks. Provider and patient will be of the same gender. Standard pharmacotherapy will be provided as needed during the treatment period. Medication and dosage will not be changed. If necessary, benzodiazepines will be administered as required.

Outcome measures:

The following assessments will be included:

  1. Medication: Use of SOS benzodiazepines
  2. Clinical rating scales: PANSS, CGI, NOSIE, Hamilton Scales for depression and anxiety

1. Side effect scales: Simpson Angus Scale, AIMS scale, UKU scale 2. Neurophysiological testing: Prepulse inhibition (PPI). 3. Neurocognitive testing: This will be performed using the NIMH's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery for Clinical Trials.


Condition Intervention
Schizophrenia
Procedure: Shiatsu

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Shiatsu Adjuvant Therapy for Hospitalized Psychiatric Patients: an Open Pilot Study

Resource links provided by NLM:


Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: June 2008
Intervention Details:
    Procedure: Shiatsu
    Shiatsu treatment provided in 40-minute sessions, twice a week for 4 weeks
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV-R diagnosis of schizophrenia or schizoaffective disorder
  2. Ages 18 and over
  3. Clinical status stable, as reflected by at least one month of drug treatment without change of anti-psychotic drug or dosage.
  4. Ability to cooperate with 40-minute sessions

Exclusion Criteria:

  1. Active fracture or other orthopedic problem
  2. Skin condition that renders treatment unsafe or painful
  3. Active infection in skin or soft tissues, such as cellulitis
  4. Any acute illness or other medical condition (e.g. solid tissue malignancy) for which shiatsu may be contraindicated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425399

Locations
Israel
Herzog Hospital, Department of Psychiatry
Jerusalem, Israel, 91351
Sponsors and Collaborators
Herzog Hospital
Investigators
Principal Investigator: Pesach Lichtenberg, M.D. Herzog Hospital
  More Information

No publications provided

Responsible Party: Dr. Pesach Lichtenberg, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00425399     History of Changes
Other Study ID Numbers: lichtenbergCTIL2
Study First Received: January 22, 2007
Last Updated: May 21, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Herzog Hospital:
Schizophrenia
Shiatsu

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014