Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

January 12, 2009 updated by: Herzog Hospital

Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study

In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.

We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.

The goals of this study are twofold:

  1. To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.
  2. To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91351
        • Herzog Hospital, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  2. Ages 18 and over
  3. Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall & Gorham, 1961) of less than 20% during a one month period prior to randomization, and 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. Unstable general medical conditions
  2. Active bone fracture or other orthopedic problem
  3. Skin condition that renders treatment unsafe or painful
  4. Active infection in skin or soft tissues, such as cellulitis
  5. Solid tissue malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure
Acupressure adjuvant therapy
Behavioral: Acupressure adjuvant therapy
Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
Other Names:
  • Shiatsu
Placebo Comparator: Placebo acupressure
Sham acupressure adjuvant therapy
Behavioral: Acupressure adjuvant therapy
Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
Other Names:
  • Shiatsu
No Intervention: No treatment
Wait list group (no treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Psychiatric Rating Scale (BPRS)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herzog Hospital

Investigators

  • Principal Investigator: Pesach Lichtenberg, M.D., Herzog Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lichtenberg3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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