CancerNCT06376344
The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy.
A study testing myofascial release with tennis ball in people with Cancer and Neuropathy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cancer, Neuropathy, Therapy-Associated Cancer
- What is being tested?
- myofascial release with tennis ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2024to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myofascial Release Using a Tennis Ball on Balance and Quality of Life in Cancer Patients With Peripheral Neuropathy: a Randomized Controlled Trial.
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.
- Conditions
- Cancer, Neuropathy, Therapy-Associated Cancer
- Being tested
- myofascial release with tennis ball
- Keywords
- Cancer pain, Neuropathy pain, Tenis ball, Myofascial release
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial release with tennis ballOther
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 group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Other: myofascial release with tennis ball |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start28 Apr 2024 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Saygılı, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376344
- Sponsor's protocol ID
- 16.04.24
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Release Using a Tennis Ball on Balance and Quality of Life in Cancer Patients With Peripheral Neuropathy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06376344
- Acronym / sponsor ID
- 16.04.24
- Conditions
- Cancer, Neuropathy, Therapy-Associated Cancer
- Keywords
- Cancer pain, Neuropathy pain, Tenis ball, Myofascial release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 28 Apr 2024 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: myofascial release with tennis ball |
| Control | No intervention | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myofascial release with tennis ballMovement 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. | Other | Study |
Primary outcome
EORTC QLQ C-30- CIPN20 Scale
Time frame: 10 minutes
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
One Leg Standing Test
Time frame: 30 seconds
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.
Lateral Reach Test
Time frame: 5 minutes
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
Pain Assessment
Time frame: 1 minutes
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
Pressure Pain Threshold Assessment
Time frame: 5 minutes
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.
Two Point Discrimination
Time frame: 10 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release with tennis ball in people with Cancer and Neuropathy, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ C-30- CIPN20 Scale (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.