Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201011000264179 Date of Approval: 17/11/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Virtual reality exposure therapy and fibromyalgia
Official scientific title Virtual reality exposure therapy therapy as treatment for pain catastrophizing in fibromylagia patients: Proof-of-concept
Brief summary describing the background and objectives of the trial Although advocated as effective for fibromyalgia (FM), the implementation of exercise in reality is hampered by patients¿ poor compliance. The inference that pain catastrophizing (PC) is a key predictor of poor compliance in FM, justifies altering PC during FM management. Virtual reality exposure therapy (VRET) has been used for other phobias, but not in the treatment of PC or chronic pain. This project aims to provide proof-of-concept for the development/trialing of VRET for PC in FMS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Fibromyalgia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/02/2011
Actual trial start date
Anticipated date of last follow up 31/05/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
N10/05/184 Health Research ethics committee of Stellenbosch University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Statistician will build a computer-generated random numbers table will be used to allocate subjects to groups. Allocation will be concealed by placing group identification in sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Statistician will build a computer-generated random numbers table will be used to allocate subjects to groups. Allocation will be concealed by placing group identification in sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Virtual reality exposure therapy one hour session twice a week 8 weeks visuals of exercise activities 10
Control Group Waiting list (no intervention) not applicable as subject will receive no intervention 8 weeks normal activities for 8 weeks 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult male and female subjects Between ages of 18 and 65 years old clinically diagnosed with FMS according to the American College Rheumatology (ACR) criteria [26] by a qualified rheumatologist subjectively report high PCS (more than 24 points) and TSK (more than 37 points) scores able to speak, read English, Afrikaans and Xhosa diagnosed with other conditions not related to FMS i.e. cancer; severe physical disabilities; suffer from other chronic conditions i.e. systemic lupus erythmatosus, rheumatoid arthritis, etc; previously been hospitalized for a major psychiatric disorder; uncontrolled endocrine or allergic disorder; using medication other than the prescribed pharmacologic agents for FMS symptoms; using any narcotics long-term; currently or who have previously abused any illicit substances or alcohol; diagnosed with epilepsy, or other conditions contraindicated in the use of visual exposures to stimuli; contraindications which prohibit the use of fMRI, i.e. cardiac pacemakers, metal implants, claustrophobia, pregnancy and cochlear implants; unable to discontinue intake of anti-depressants 4 weeks prior to commencement of study 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/07/2010 Health Research Ethics Committee of Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Franci van Zyl road Tygerberg 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2011 Health Research Ethics Commitee of Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Francie van Zyk road Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain catastrophizing experimental group: pre-and post treatment, before and after each twice weekly session control group: pre- and post-treatment
Secondary Outcome Kinesiophobia Experimental group: pre-and post-treatment; before and after each twice weekly session. Control group: pre-and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Rheumatology clinic Francie van Zyl road Tygerberg 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Harry Crossley Foundation van Ryn street Stellenbosch University 7602 South Africa
Harry Crossley Foundation van Ryn street Stellenbosch University 7602 South Africa
Stellenbosch University Postgraduate merit award van Ryn street Stellenbosch 7602 South Africa
Stellenbosch University Postgraduate merit award van Ryn street Stellenbosch 7602 South Africa
National Research Fund Meiring Naude Road, Brummeria, PO Box 2600 Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Linzette Morris 140 Spencer Street Goodwood 7460 South Africa Funding Agency
Primary Sponsor Linzette Morris 140 Spencer Street Goodwood 7460 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Stellenbosch University Francie van Zyl road Tygerberg 7505 South Africa
Stellenbosch University Francie van Zyl road Tygerberg 7505 South Africa
Tygerberg Hospital Francie van Zyl road Tygerberg 7505 South Africa
Tygerberg Hospital Francie van Zyl road Tygerberg 7505 South Africa
CUBIC Francie van Zyl road Tygerberg 7505 South Africa
CUBIC Francie van Zyl road Tygerberg 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Linzette Morris ldmorris@sun.ac.za +27 21 5925132 140 Spencer Street
City Postal code Country Position/Affiliation
Goodwood 7460 South Africa Researcher/Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Linzette Morris ldmorris@sun.ac.za +27 215925132 140 Spencer Street
City Postal code Country Position/Affiliation
Goodwood 7460 South Africa Researcher/Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Linzette Morris ldmorris@sun.ac.za +27 21 5925132 140 Spencer Street
City Postal code Country Position/Affiliation
Goodwood 7460 South Africa Researcher/Stellenbosch University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information