Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients

Peripheral Neuropathy Clinical Trial

Official title:

Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111730
• Other study ID #: P.T.REC/012/002568
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: October 2021
• Source: South Valley University
• Contact: Mohammed E Ali, Ph.D student
• Phone: 01011212425
• Email: m.essam[@]svu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.

Description:

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 nonpharmacologic 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 40 Years

Eligibility

Inclusion Criteria:

• Their age will ranging from eight to forty years.

• All cases participated in this study will from both sexes.

• All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy

• All cases have polyneuropathy caused by chemotherapy.

Exclusion Criteria:

• Patient with osteoporosis.

• Patient with DVT.

• Patient have a Pacemaker fitted

• Uncooperative patients

Related Conditions & MeSH terms

• Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• The Shock wave Therapy.
Shockwave therapy is a multidisciplinary device used in orthopedics, physiotherapy, sports medicine, urology and veterinary medicine. Its main assets are fast pain relief and mobility restoration. Together with being a non-surgical therapy with no need for painkillers makes it an ideal therapy to speed up recovery and cure various indications causing acute or chronic pain. Shockwave is an acoustic wave which carries high energy to painful spots and myoskeletal tissues with sub-acute, sub-chronic and chronic conditions. The energy promotes regeneration and reparative processes of the bones, tendons and other soft tissues. Shockwaves are characterized by jump change in pressure, high amplitude and non-periodicity. The kinetic energy of the projectile, created by compressed air, is transferred to the transmitter at the end of the applicator and further into the tissue.

Locations

Country	Name	City	State
Egypt	South Valley University, Faculty of Physical Therapy	Qina	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malondialdehyde (MDA) as oxidative stress marker	Malondialdehyde level in blood will be measured	Malondialdehyde (MDA) level was assessed at day 0.
Primary	Malondialdehyde (MDA) as oxidative stress marker	Malondialdehyde level in blood will be measured	Malondialdehyde (MDA) level will be assessed at day 90.
Primary	Interlukin 6 (IL-6) as inflammatory marker	Interlukin 6 (IL-6) level in blood will be measured	Interlukin 6 (IL-6) level was assessed at day 0.
Primary	Interlukin 6 (IL-6) as inflammatory marker	Interlukin 6 (IL-6) level in blood will be measured	Interlukin 6 (IL-6) level will be assessed at day 90.
Primary	Plasma Neurotensin (NT) as potential marker for neuropathic pain	Plasma Neurotensin (NT) level in blood will be measured	Plasma Neurotensin (NT)level was assessed at day 0.
Primary	Plasma Neurotensin (NT) as potential marker for neuropathic pain	Plasma Neurotensin (NT) level in blood will be measured	Plasma Neurotensin (NT)level will be assessed at day 90.