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.: PACTR202306518405461 Date of Approval: 22/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Cold Application versus Transcutaneous Nerve Stimulation on Chemotherapy Induced Diabetic Peripheral Neuropathy Post Mastectomy
Official scientific title Effect of Cold Application versus Transcutaneous Nerve Stimulation on Chemotherapy Induced Diabetic Peripheral Neuropathy Post Mastectomy
Brief summary describing the background and objectives of the trial Background: The adverse effect of Chemotherapy‑induced diabetic peripheral neuropathy (CIDPN) is rather prevalent. There is no known pharmaceutical treatment that can stop CIDPN. Objective: This research compared the effects of cold application and transcutaneous nerve stimulation (TENS) on individuals who had undergone mastectomy following chemotherapy-induced diabetic peripheral neuropathy. Additionally, people who have been diagnosed with cancer may experience new onset diabetes or impaired glycemic control due in part to the systemic anti-cancer treatments (SACT) they receive. The gate control theory states that cold treatment slows down nerve transmission, which inhibits nociceptive receptors and lowers pain perception by boosting endogenous opioid release. TENS therapy has also been demonstrated to reduce dorsal horn neuron sensitization, increase levels of gamma-aminobutyric acid and glycine, and block glial activation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date 29/09/2022
Anticipated target sample size (number of participants) 43
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
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 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
Control Group Cold Application three times per week for twelve weeks • For 12 weeks, three times a week, cold packs were used. • The treatment region was examined for infection, scar tissue, irritation, and incisions before the operation was disclosed to the patient and their family. • The patient received the ideal, cosy posture. • For the ankles, cold packs of 30 cm by 20 cm were employed. • To avoid coming into touch with the cold, nonsterile gauze compresses (10 cm 10 cm) were placed around the application regions. • Two 15-minute applications of frozen cold compress packets were made for a total of 30 minutes. • The intervals between applications were 45 minutes. • During each intervention, we looked for adhesion to cold application, pain, abnormal sensations, and other cold application-related discomforts. 15 Active-Treatment of Control Group
Experimental Group Transcutaneous Nerve Stimulation three times per week for twelve weeks • Each patient in group (B) was lying down comfortably. • Four adhesive electrodes were used with TENS on the skin of the lower limbs as follows: ­ One electrode was put at the lower edge of the medial tibial condyle, the other three inches above the medial malleolus close to the tibia of the right lower leg (first channel). ­ One electrode was positioned at the medial tibial condyle's lower border, while the other electrode was positioned three inches above the medial malleolus, near to the left lower limb's tibia (second channel). • The device was turned on, and the intensity was adjusted to create strong, rhythmic visible muscular contractions under the electrodes (moderately bearable intensity), with a low frequency of 15Hz and a pulse width of 250 sec. • The treatment lasted 30 minutes, three times a week for a period of 12 weeks. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chemotherapy-induced diabetic peripheral neuropathy following mastectomy. They were between the ages of 45 and 60. Pregnancy Amputation Physical therapy in the previous six months. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 29/11/2022 research ethical committee at faculty of physical therapy modern university for technology and information
Ethics Committee Address
Street address City Postal code Country
Elhadaba Elwosta, Mokatm Cairo 12566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Visual Analogue Scale baseline and after 12 weeks
Primary Outcome Nerve Conduction Studies baseline and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Modern University for Technology and Information Elhadaba Elwosta, Mokatm Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed M Elshinnawy Fostat city, Old Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed M. Elshinnawy Fostat city, Old Egypt Cairo Egypt Individual
Secondary Sponsor Zeezy S. Eraky Fostat City, Old Egypt Cairo Egypt Individual
Secondary Sponsor Sarah Sami Abdelaziz Nasr city Cairo Egypt Individual
Secondary Sponsor Noha A.F Abd Elrahman Nasr City Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ahmed M. Elshinnawy Fostat City, Old Egypt Cairo Egypt
Zeezy S. Eraky Fostat City, Old Egypt Cairo Egypt
Sarah Sami Abdelaziz Nasr City Cairo Egypt
Noha A.F Abd Elrahman Nasr City Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed M. Elshinnawy Dr.ahmed.m.elshinnawy@pt.mti.edu.eg 01092070555 Fostat City, Old Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy Department of Physical Therapy for Neuromuscular Disorders and its Surgery
Role Name Email Phone Street address
Principal Investigator Zeezy S. Eraky zeezyeraky@gmail.com 01003934051 Fostat City, Old Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Physical Therapy Department of Physical Therapy for Internal Medicine and Elderly
Role Name Email Phone Street address
Public Enquiries Sarah Sami Abdelaziz sarahsami_wh@hotmail.com 010066017960 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Department of Physical Therapy For Surgery
Role Name Email Phone Street address
Scientific Enquiries Noha A.F Abd Elrahman nonabird79@yahoo.com 01287499364 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Department of Physical Therapy for Women Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to sharing data with the requesting party. Statistical Analysis Plan,Study Protocol within three months open access
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