Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00788970
• Other study ID #: lichtenberg3
• Status: Not yet recruiting
• Phase: N/A
• First received: November 10, 2008
• Last updated: January 12, 2009
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2009
• Source: Herzog Hospital
• Contact: Pesach Lichtenberg
• Phone: 972-2-5316929
• Email: licht[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Israel	Herzog Hospital, Department of Psychiatry	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Psychiatric Rating Scale (BPRS)		16 weeks	No