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

NCT05111730 | Unknown

• 1 other identifier: P.T.REC/012/002568
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Neuropathy

Keywords

PERIPHERAL NEUROPATHY; CHEMOTHERAPY; SHOCKWAVE

Outcome Measures

Primary Outcomes (6)

• Malondialdehyde (MDA) as oxidative stress marker

  Malondialdehyde level in blood will be measured

  Malondialdehyde (MDA) level was assessed at day 0.

• Malondialdehyde (MDA) as oxidative stress marker

  Malondialdehyde level in blood will be measured

  Malondialdehyde (MDA) level will be assessed at day 90.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

The shockwave Group

EXPERIMENTAL

Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months.

Device: The Shock wave Therapy.

the traditional treatment group

NO INTERVENTION

group (B) control group received medical care and standard chemotherapy only.

Interventions

The Shock wave Therapy. DEVICE

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.

The shockwave Group

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient with osteoporosis.
• Patient with DVT.
• Patient have a Pacemaker fitted
• Uncooperative patients

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, 83523, Egypt

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mohammed E Ali, Ph.D student

  South Valley University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed E Ali, Ph.D student

CONTACT

01011212425; m.essam@svu.edu.eg

Nehad A. Abo-zaid, Ph.D

CONTACT

+201223265216; dr.nehadahmed@svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 8, 2021
• Study Start: December 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)