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

NCT ID: NCT05111730

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Neuropathy

Keywords

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PERIPHERAL NEUROPATHY CHEMOTHERAPY SHOCKWAVE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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The shockwave Group

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

Group Type EXPERIMENTAL

The Shock wave Therapy.

Intervention Type 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 traditional treatment group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed E. Ali, Ph. D Candidate.

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed E Ali, Ph.D student

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Locations

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South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed E Ali, Ph.D student

Role: CONTACT

Phone: 01011212425

Email: [email protected]

Nehad A. Abo-zaid, Ph.D

Role: CONTACT

Phone: +201223265216

Email: [email protected]

Facility Contacts

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Mohammed E. Ali., Ph.D student

Role: primary

Nehad A. Abo-zaid, Ph.D

Role: backup

Other Identifiers

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P.T.REC/012/002568

Identifier Type: -

Identifier Source: org_study_id