Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children
Phase: NA
Conditions: Cancer
Sponsor: South Valley University

Official Title of Study: - 
EFFECT OF CRYOTHERAPY INCONTROLLING 
PERIPHERAL NEUROPATHY IN PEDIATRIC 
TUMOR PATIENTS 
 
 
 
 
 
Document Date: - 08/27/2020. 
 
 
 
 
 
 
Human Subjects protection review board approval 
date: - 12/01/2019 

Updated 23/11/12 
 
 
1 
 
FACULTY OF PHYSICAL THERAPY 
APPLICATION FOR ETHICAL REVIEW 
 
 
 
NOTES: 
 
➢ 
Answers to questions must be entered in the space provided. 
➢ 
An electronic version of the completed form should be submitted to the Research Ethics 
Officer, at the following email address: …ethical@pt.cu.edu.eg……. Please do not submit 
paper copies. 
➢ 
If you have any queries about the form, please address them to the Research Ethics Team. 
 
 
 

Updated 23/11/12 
 
 
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FACULTY OF PHYSICAL THERAPY 
APPLICATION FOR ETHICAL REVIEW 
OFFICE USE ONLY: 
Application No: 
Date Received: 
 
1. TITLE OF PROPOSAL 
EFFECT OF CRYOTHERAPY INCONTROLLING PERIPHERAL 
NEUROPATHY IN PEDIATRIC TUMOR PATIENTS 
 
2. THIS PROPOSAL IS:  
 
Physical TherapyStaff Research Proposal 
 
 
Physical TherapyPostgraduate Research (PGR) Student Proposal
 
Master 
 
Doctoral 
 
Other  
 
 
          Other  
(Please specify):        
 
 
3. INVESTIGATORS  
 
a) PLEASE GIVE DETAILS OFStudent(FOR PGR STUDENT PROPOSAL)or first author for 
staff Research Proposal 
 
Name:      Title / first name / family name 
Hebaahmedmetwally 
Highest qualification & position held: 
Lecture of physical therapy/ faculty of physical therapy 
Department/Faculty/ University 
Cario University 
Telephone: 
01289213128 
Email address: 
Dr_hobi@yahoo.com 
 
 
 
 
a) PLEASE GIVE DETAILS OF ANYCO-SUPERVISORS ORCO-INVESTIGATORS (FOR PGR 
STUDENT PROPOSAL) or co- first author for staff Research Proposal 
b)  
 
Name:      Title / first name / family name 
Nehadahmedyouness abo-zeid 
Highest qualification & position held: 
Lecture of physical therapy/ faculty of physical therapy 
Department/Faculty/ University 
South Vally University 
Telephone: 
01223265216 
Email address: 
Dr.nona77@yahoo.com 
 
Name:      Title / first name / family name 
 
Highest qualification & position held: 
 
Department/Faculty/ University 
 
Telephone: 
 
Email address: 
 
 
Name:      Title / first name / family name 
 
Highest qualification & position held: 
 
Department/Faculty/ University 
 
Telephone: 
 
Email address: 
 
 
 
4. SUMMARY OF PROPOSAL 
 
 
 
 

Updated 23/11/12 
 
 
3 
 
PURPOSE: 
This study aimedassess the efficacy of cryotherapy in controlling Peripheral 
Neuropathy in pediatric tumors patients 
 
BACKGROUND: 
Peripheral neuropathy is a serious condition characterized by symmetrical, distal 
damage to the peripheral nerves that may be caused by several classes of drugs, 
including 
chemotherapeutic 
agents. 
Chemotherapy-induced 
peripheral 
neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of 
patients undergoing chemotherapy, with its incidence increasing in patients being 
treated with multiple agents. Pharmacists play a pivotal role in the prevention 
and management of CIPN by recommending evidence-based pharmacologic and 
non pharmacologic strategies appropriate for the individual patient.Peripheral 
neuropathy (PN) is a systemic disease characterized by symmetrical, distal 
damage to the peripheral nerves that negatively impacts patient quality of life 
(QOL). Prolonged symptoms associated with PN can cause pain, interfere with 
functional ability (e.g., dressing, driving, house-work), and disrupt emotional 
health. 
HYPOTHESES: 
 
H0 there is no significance difference of cryotherapy in controlling Peripheral 
Neuropathy in pediatric tumors patients 
H1 there is a significance difference of cryotherapy in controlling Peripheral 
Neuropathy in pediatric tumors patients 
RESEARCH QUESTION: 
Is there is significance difference of cryotherapy in controlling Peripheral 
Neuropathy in pediatrictumors patients? 
 
 
 
5. CONDUCT OF PROJECT 
 
 
Please give a description of the research methodology that will be used  
 

Updated 23/11/12 
 
 
4 
 
 
 
• Nerve conduction studies (NCS) and somatosensory-evoked 
potentials (SSEPs) were used to assess peripheral neuropathy 
pre and post intervention.  
•  
. 
6. PARTICIPANTS AS THE SUBJECTS OF THE RESEARCH 
Describe the number of participants and important characteristics (such as age, gender, intellectual 
ability etc.). Specify any inclusion/exclusion criteria to be used. 
 

Updated 23/11/12 
 
 
5 
Subjects: 
Eighty children with tumors were enrolled in this study and were assessed for 
eligibility. Their aged ranged from six and fourteen years. They were assigned 
randomly into two equal groups. Group (A) study group received the same 
medical care and shockwave, three times / weak for three successful months. And 
group (B) control group received medical care and standard chemotherapy 
only.Nerve conduction studies (NCS) and somatosensory-evoked potentials 
(SSEPs) were used to assess peripheral neuropathy pre and post intervention. All 
children were assisted before and after three months of intervention.  
Inclusion criteria: 
1. 
Their age will ranging from six to fourteen years.  
2. 
Childrenparticipated in this study will from both sexes. 
3. 
Children receiving chemotherapy as primary treatment, postoperative surgical removal 
of tumors  or with conjunction with radiotherapy  
4. 
All children have polyneuropathy caused by chemotherapy. 
 
Exclusion criteria: 
1. 
Children with Epilepsy. 
2. 
Children with blood clotting disorder. 
3. 
Children have Open wounds / broken skin 
4. 
Children with severe cardiac disease 
5. 
Uncooperative patients. 
 
 
7. RECRUITMENT 
Please state clearly how the participants will be identified, approached and recruited.  
 
 
Note: Attach a copy of any poster(s), advertisement(s) or letter(s) to be used for recruitment. 
 
The patients will be recruited from Outpatient Clinic of faculty of medicine, South Vally University. 
 
8. CONSENT  
Describe the process that the investigator(s) will be using to obtain valid consent.  If consent is not to 
be obtained explain why. If the participants are minors or for other reasons are not competent to 
consent, describe the proposed alternate source of consent, including any permission / information 
letter to be provided to the person(s) providing the consent. 
I am                              freely and voluntarily consent to participate in a research program under the 
direction of M.Sc. 
A thorough description of the procedure has been explained and I understand that I may withdraw 
my consent and discontinue participation in this research at any time without prejudice to me. 
Date                                   Participant 
 إقرار 
                             أقر انا الموقع أدناه أ نني وفقت علي األشتراك في برنامج البحث تحت إشراف الباحث 
 وقد تم شرح خطوات البحث لي بالتفصيل وأنه من حقي أن انسحب من الدراسة في أي وقت أشاء 
لتاريخ                                                                                          المشارك 
     Note: Attach a copy of theConsent Form, Participant Information Sheet (if applicable).  
 
 
 

Updated 23/11/12 
 
 
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PARTICIPANT WITHDRAWAL  
 
a) Describe how the participants will be informed of their right to withdraw from the project.  
Allparents will sign a written consent form after receiving information about the study purpose, whole 
procedures, possible benefits, privacy and use of data to ensure full cooperation. parents well 
understand that they may withdraw their consent and discontinue participation in the research at any 
time without prejudice to them. 
 
b) Explain any consequences for the participant of withdrawing from the study and indicate what will 
be done with the participant’s data if they withdraw. 
 
All data of withdrawn participant will be excluded form analysis. 
 
9. CONFIDENTIALITY 
 
   
 
 
a) 
Will all participants be anonymous?  
 
 
 
 
Yes 
 No 
 
b) 
Will all data be treated as confidential? 
 
 
 
 
Yes
 No 
 
 
Note: Participants’ identity/data will be confidential if an assigned ID code or number is used, but it will 
not be anonymous. Anonymous data cannot be traced back to an individual participant. 
 
10. SIGNIFICANCE/BENEFITS 
Outline the potential significance and/or benefits of the research  
 
The use of freezing temperatures for analgesia has been recorded for thousands of years. Modern 
cryotherapy has slowly become a well-established treatment option for peripheral neuralgias and 
neuropathic pain conditions. Cryoneurolysis induces peripheral nerve damage and causes nerves 
to undergo axonotmesis followed by Wallerian degeneration. Nerve regrowth occurs but may not 
lead to permanent pain relief. The therapy continues to be optimized and is best used for well-
defined small nerves that are easy to target. The use of cryotherapy has been indicated for 
intercostal neuralgia, occipital neuralgia, trigeminal neuralgia, phantom limb pain, obturator 
neuralgia, genitofemoral neuralgia, and intractable perineal pain. 
 

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11. RISKS 
 
 Outline any potential risks to INDIVIDUALS, including research staff, research participants, other individuals 
not involved in the research  and the measures that will be taken to minimise any risks and the 
procedures to be adopted in the event of mishap 
 
All patients will be given an explanatory session before starting evaluation 
procedures to be aware about different steps of test. 
 
 
 
 
12. DECLARATION BY APPLICANTS 
 
I submit this application on the basis that the information it contains is confidential and will be used by the 
Faculty of Physical Therapy for the purposes of ethical review and monitoring of the research project  
describedherein, and to satisfy reporting requirements to regulatory bodies.  The information will not be used 
for any other purpose without my prior consent. 
 
 
 
 
 
 
I declare that: 
• 
The information in this form together with any accompanying information is complete and correct to 
the best of my knowledge and belief and I take full responsibility for it. 
• 
I will report any changes affecting the ethical aspects of the project to the Faculty of Physical 
Therapy Research Ethics Officer. 
• 
I will report any adverse or unforeseen events which occur to the relevant Ethics Committee via the 
Faculty of Physical TherapyResearch Ethics Officer. 
 
 
Name of Principal investigator/project supervisor: 
 
Dr Hebaahmed metwally 
 
Date:19/11/2019