NCT06376344

Brief Summary

This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

April 28, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 16, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

Cancer painNeuropathy painTenis ballMyofascial release

Outcome Measures

Primary Outcomes (6)

  • EORTC QLQ C-30- CIPN20 Scale

    The patients' quality of life will be evaluated with the EORTC QLQ-C30, which was developed by EORTC for cancer patients and is widely used all over the world. The first 28 of the scale, which consists of three subheadings and 30 questions, namely functional difficulties, symptom control and general well-being, are four-point Likert type, and the answers are given as "Not at all", "Somewhat", "2", Somewhat "3", Very "4". is evaluated. In the 29th and 30th questions of the scale, the patient is asked to evaluate his/her general well-being by using a linear analog scale and giving a value from 1 to 7 ("1" is very bad and "7" is excellent). Functional scale: physical function (questions 1-5), role function (questions 6 and 7), emotional function (questions 21-24), cognitive function (questions 20 and 25) and social function (questions 26 and 27). )consists of subgroups

    10 minutes

  • One Leg Standing Test

    During the test, the participant is asked to cross his arms in front of his body and lift one leg without touching the support leg. Initially, his eyes are open. The eyes are fixed in the direction of the head, the participant is asked to close his eyes and is expected to maintain his balance for 30 seconds.

    30 seconds

  • Lateral Reach Test

    In the lateral reach test, the participant is asked to turn his back to the wall, stand close to it but not touch it, and keep his arm close to the wall by abducting it at 90 degrees

    5 minutes

  • Pain Assessment

    Pain will be assessed with the Visual Analog Scale (VAS) \[20\]. Patients are explained that the number "0" on a 10 cm horizontal line means no pain, and the number "10" means "unbearable pain

    1 minutes

  • Pressure Pain Threshold Assessment

    In quantitative pain threshold measurement, a 1 cm2 surface algometer will be used to measure the pressure pain threshold. The algometer is positioned upright, the pressure is increased to 1kg/cm2 at the painful point every three seconds, and the measurements are repeated 3 times with a 30-second rest period in between. The average of 3 measurements is used for analysis.

    5 minutes

  • Two Point Discrimination

    Participants will be evaluated in a sitting position with eyes closed using an aesthesiometer (Instrument Company, Lafayette, IN, USA). Evaluation will be made from the trans-metatarsal area, middle of the foot and middle of the heel. It will start from the interval where two points can be easily distinguished. The distance between two points will be reduced in 1 mm intervals until the two points are felt as a single point.

    10 minutes

Study Arms (2)

Study

EXPERIMENTAL
Other: myofascial release with tennis ball

Control

NO INTERVENTION

Interventions

Movement of the Tennis Ball on the Sole of the Foot: The tennis ball is moved under the foot by back and forth movements and by applying pressure. The aim is to briefly keep the pressure of the ball on the body and the stress indicated by the massage on.

Study

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complaints of peripheral neuropathy among patients who have completed the standard chemotherapy treatment protocol due to colorectal cancer, entered the follow-up process and come to the outpatient clinic for routine control.
  • Registered to Selçuk University Faculty of Medicine Hospital Medical Oncology Polyclinic
  • Karnofsky Performance Scale must be 80 or above
  • Over 25 years old, under 65 years old
  • Presence of grade 2 or higher peripheral neuropathy,
  • Being conscious and cooperative
  • Verbal and written approval to participate in the study after an explanation about the study is made.

You may not qualify if:

  • Having any skin sensitivity on hands and feet before
  • Refused to participate in the study after making a statement about the study
  • Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
  • Bone or spine metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ülkü Saygili Düzova

Selçuklu, Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsNeoplasms, Second PrimaryCancer Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

April 28, 2024

Primary Completion

June 10, 2024

Study Completion

July 10, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations