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.: PACTR202202840480963 Date of Approval: 22/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION ON THE LEVEL OF INTERLEUKIN “6” AND “10” POST PLEURODESIS
Official scientific title THE EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION ON THE LEVEL OF INTERLEUKIN “6” AND “10” POST PLEURODESIS
Brief summary describing the background and objectives of the trial Pleurodesis can be one of the most painful types of incision that patients can experience. Pain may inhibit effective coughing, deep breathing and restrict early postoperative mobilization. As a result, lung ventilation and independence self-care may not be optimal with a tendency to lung infection. Furthermore, inadequate acute postoperative pain management may contribute to the development of a chronic post- pleurodesis pain syndrome. Purpose of the study: To assess the effect of TENS on the level of the (INTERLEUKIN) IL6 and (INTERLEUKIN) IL10 post pleurodesis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Musculoskeletal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/03/2022
Actual trial start date
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group medications in addition to placebo effect of TENS 48 hours after surgery diclofenac sodium 75 mg as an NSAID (non-steroidal anti-inflammatory drugs) for incisional pain relief and morphine 5 mg as an opioid for central pain desensitization in addition to the placebo effect of TENS 30 Active-Treatment of Control Group
Experimental Group TENS with frequency 80 Hz 48 hours after surgery TENS with frequency 80 Hz for 45 minutes for each session one-hour after recovery from anesthesia for 48 hrs., in addition to diclofenac sodium 75 mg as an NSAID (non-steroidal anti-inflammatory drugs) for incisional pain relief and morphine 5 mg as an opioid for central pain desensitization. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Sixty patients of both sexes undergo posterolateral thoracotomy as a procedure for pleurodesis. • Their ages will be from 30-40 years old. • Patients with moderate pain severity detected by CPOT with a score > 2. • Both groups will receive diclofenac sodium 75 mg as an NSAID (non-steroidal anti-inflammatory drugs) for incisional pain relief and morphine 5 mg as an opioid for central pain desensitization • Patients with hemodynamic stability. • Patients with chronic chest diseases. • Patients with chronic renal failure. • Patients with cardiac diseases. • Diabetic patients. • Patients with neurological diseases. • Patients with pacemaker implantation. • Uncooperative patients. • Debilitated patients with unstable hemodynamics. Adult: 19 Year-44 Year 30 Year(s) 40 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 09/09/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elzyat street Giza 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Laboratory Investigations: Cytokines: IL6, IL10. before surgery, at 6, 12, 24 and 48 postoperative hours
Secondary Outcome Critical Care Observational Tool before surgery and 48 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute 2 elkaser elaini street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ismail Hosni Ismail 58 taha hussein street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Cancer Institute Faculty of Medicine Cairo University. 2 elkaser elani street Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ismail Hosni Ismail ismail.hosni@hu.edu.eg 01145806614 56 Taha hussein street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of Physical therapy for Cardiovascular Respiratory disorder and Geriatrics Heliopolis university
Role Name Email Phone Street address
Public Enquiries Akram Abd Al Aziz Sayed akramsayed@hotmail.com 01227362806 44 eldoky street
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor of Physical therapy for Cardiovascular Respiratory disorders and geriatrics Cairo university.
Role Name Email Phone Street address
Scientific Enquiries Mona Ahmed Mohamed monaahmed198748@yahoo.com 01147514673 28 bein srayat street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer Physical therapy for Cardiovascular Respiratory disorders and geriatrics faculty of physical therapy Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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