Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05111730
Enrollment
80
Registered
2021-11-08
Start date
2021-12-01
Completion date
2022-05-01
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy

Keywords

PERIPHERAL NEUROPATHY, CHEMOTHERAPY, SHOCKWAVE

Brief summary

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

Detailed 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.

Interventions

DEVICEThe 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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (study group) and Group B ( control group).

Intervention model description

Eighty children with tumors were enrolled in this study and were assessed for eligibility. Their aged ranged from eight and forty years. They were assigned randomly into two equal groups. Group (A) study group received the same medical care and shock wave, 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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Malondialdehyde (MDA) as oxidative stress markerMalondialdehyde (MDA) level was assessed at day 0.Malondialdehyde level in blood will be measured
Interlukin 6 (IL-6) as inflammatory markerInterlukin 6 (IL-6) level was assessed at day 0.Interlukin 6 (IL-6) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic painPlasma Neurotensin (NT)level was assessed at day 0.Plasma Neurotensin (NT) level in blood will be measured

Countries

Egypt

Contacts

Primary ContactMohammed E Ali, Ph.D student
m.essam@svu.edu.eg01011212425
Backup ContactNehad A. Abo-zaid, Ph.D
dr.nehadahmed@svu.edu.eg+201223265216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026