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.: PACTR201906866179350 Date of Approval: 21/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Outcome of Cognitive Beharioural Therapy in the Management of Patients with Chronic Pain at the University Teaching Hospital
Official scientific title A Crossover Design for Comparative Efficacy: A 28 Days-Randomized Trial of CBT and PT Treatments for Chronic pain of degenerative conditions
Brief summary describing the background and objectives of the trial This is a trial for the treatment of pain dimensions for degenerative conditions. the rationale is that Cognitive behavioral therapy is effective for the treatment of chronic in this conditions and if it can be used in tandem with the physiotherapy standard treatment the benefits could be almost doubled. This is 2 weeks crossover design with a sample of 32 patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/06/2019
Actual trial start date
Anticipated date of last follow up 13/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive behavioral Therapy and Physiotherapy 2 hour session of treatment for a day 28 days Cognitive behavioral therapy and physiotherapy will be used to attenuate pain for degenerative conditions 17
Control Group Physiotherapy treatment 2 hours session per day 28 days Physiotherapy will be given to attenuate pain for degenerative conditions 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Have experienced pain that has persisted for more than six weeks • Patients aged 18 to 65 years • Patients that are not mentally sound • Patients with neuropathies or radiculopathies • Pregnant women • Patients with pain for less than six weeks • Patients below the age of 18 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 10/06/2019 University of Zambia Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nationalist Road LUSAKA 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The co-primary endpoints were the change from baseline in mean pain dimensions at 2 weeks. Pain dimension will be measured at the beginning for at least 5 minutes. Pain dimensions will be measured with a brief pain tool scale, 1 time at the beginning, at end and replicated in the other sequencey of the crossover and a mean of the 4 measurements was calculated 4 time points
Secondary Outcome coping strategy end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The University Teaching Hospital BOX 50110 Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Nchawanangwa Nationalist Road Lusaka 10101 Zambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Higher Education Lusaka Lusaka 10101 Zambia Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Charity Kapenda Nationalist road Lusaka 10101 Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NCHAWANANGWA KAONGA kaonganchawanangwa@gmail.com +26076040361 NATIONALIST ROAD
City Postal code Country Position/Affiliation
LUSAKA 10101 Zambia STUDENT
Role Name Email Phone Street address
Scientific Enquiries BRIAN CHILUBA brian.chiluba@unza.zm +260977896377 Nationalist Road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Lecturer
Role Name Email Phone Street address
Public Enquiries CHARITY KAPENDA charity.kapenda@unza.zm +260977896377 Nationalist Road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that will be collected from this study will be shared Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The findings will be shared by August or September of 2019 access may be requested by Brian Chiluba. This will be decided by a third party Ms Charity Kapenda.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information