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.: PACTR201501000986244 Date of Approval: 02/01/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A fixed dose combination of diclofenac sodium plus chlorzoxazone with or without Cupping in low back pain
Official scientific title Efficacy and safety of a fixed dose combination of diclofenac sodium plus chlorzoxazone with and without a dry Cupping under heat technique in the treatment of non-specific low back pain
Brief summary describing the background and objectives of the trial Nonspecific low back pain is a very common problem encountered in outpatient clinics. Non-steroidal anti-inflammatory drugs, muscle relaxants as well as acupuncture, cupping and other alternative therapies are commonly prescribed in the treatment. We planned this randomized, single-blind clinical study with 2x2 factorial design to study the effect of a fixed dose combination of 50 mg of diclofenac sodium with 50 mg of chlorzoxazone treatment twice daily alone or combined with a dry cupping under infrared heat technique versus the effect of placebo capsules alone or combined with the same cupping under heat technique for a maximum duration of 3 weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/05/2012
Actual trial start date 05/06/2012
Anticipated date of last follow up 05/06/2013
Actual Last follow-up date 12/09/2013
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 95
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer generated block randomization using fixed block size 8 the study was single blinded, only participants blinded Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 was treated with twice daily doses of ¿Declophen plus¿ capsules one capsule twice daily 3 weeks a fixed dose combination of diclofenac sodium 50 mg plus chlorzoxazone 50 mg in a hard gelatin capsule. 24
Control Group Placebo one capsule twice daily 3 weeks hard gelatin capsules similar to experimental drug 23
Experimental Group Group 3, a combined treatment, Declophen plus combined with dry cupping technique one capsule twice daily combined with 10 sessions of dry cupping 3 weeks combined oral treatment and dry cupping 24
Control Group Placebo capsules similar to Declophen plus icombined with Cupping technique one capsule twice daily combined with 10 sessions of dry cupping 3 weeks placebo capsules combined with Cupping 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
an adult male or female 20 to 65 years old presenting with a chief complaint of low back pain at least 7 days duration. detection of any recognizable, specific spinal pathology or any of the following risk factors or (red flags) including: Recent history of violent trauma, constant progressive, non-mechanical pain (no relief with bed rest), thoracic pain, past medical history of malignant tumor, prolonged use of corticosteroids, drug abuse, immunosuppression, HIV, serious or severe systemic disease, widespread or local neurological manifestations (including cauda equina syndrome), structural deformity, fever or any signs of serious infection, active peptic ulcer, inflammatory bowel disease or any acute surgical abdominal condition 20 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 19/03/2012 Green CRC IRB # 1
Ethics Committee Address
Street address City Postal code Country
Green Street Alexandria 21121 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Bournemouth Questionnaire Total Score (lowest 0, worst 70) during the previous 7 days before treatment (at baseline) at day 7 at day 21
Secondary Outcome The Clinical Global Impression of Change Questionnaire Scale Score (CGI-C) at day 21
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Green Clinic and Research Center 27 Green Alexandria 21121 Egypt
Helmy Polyclinic Broadcast street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Green CRC Green street Alexandria 21121 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Yakoot Green street Alexandria 21121 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sherine Helmy Broadcast street Alexandria Egypt
Amel Salem Ras Elteen Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Yakoot yakoot@yahoo.com +201223927561 Green
City Postal code Country Position/Affiliation
Alexandria 21121 Egypt Consultant physician, Green CRC
Role Name Email Phone Street address
Public Enquiries Mostafa Yakoot yakoot@yahoo.com +201223927561 Green
City Postal code Country Position/Affiliation
Alexandria 21121 Egypt Consultant physician, Green CRC
Role Name Email Phone Street address
Scientific Enquiries Mostafa Yakoot yakoot@yahoo.com +201223927561 Green
City Postal code Country Position/Affiliation
Alexandria 21121 Egypt Consultant physician, Green CRC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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