Multiple SclerosisNCT04936555
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
A study testing Self-Acupressure in people with Multiple Sclerosis, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Self-Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 15 Jul 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be able to communicate adequately
- Not having psychiatric problems
- Volunteering to participate in research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zain Universitiy
Istanbul, State, 34303
About this study
It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems.
Read the detailed description
The application of Self-Acupressure helps in improving the functional composite and quality of life in Multiple Sclerosis patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Self-Acupressure
- Keywords
- Self-Acupressure, Functional composite, Quality of life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-AcupressureOther
Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
| Study group | Role | What they receive |
|---|---|---|
| Self-Acupressure | Experimental | Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left) Receives: Other: Self-Acupressure |
| No Intervention | No intervention | Control group Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite (MSFC)
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Measured: 1. week
Multiple Sclerosis Functional Composite (MSFC)
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Measured: 4. week
Multiple Sclerosis Quality of Life Scale-54
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Measured: 1.week
Multiple Sclerosis Quality of Life Scale-54
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Measured: 4.week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 May 2021
- Primary completion1 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz ÖZER, PhD, Study chair, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936555
- Sponsor's protocol ID
- 26915
- Status last verified
- Jul 2021
- First submitted
- 15 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bastani F, Sobhani M, Emamzadeh Ghasemi HS. Effect of acupressure on fatigue in women with multiple sclerosis. Glob J Health Sci. 2015 Jan 26;7(4):375-81. doi: 10.5539/gjhs.v7n4p375.
PubMed 25946938
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04936555
- Acronym / sponsor ID
- 26915
- Conditions
- Multiple Sclerosis
- Keywords
- Self-Acupressure, Functional composite, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 23 Jun 2021 (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.
It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems.
Detailed description
The application of Self-Acupressure helps in improving the functional composite and quality of life in Multiple Sclerosis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Self-Acupressure | Experimental | Other: Self-AcupressureEach application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left) |
| No Intervention | No intervention | –Control group Routine maintenance will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be able to communicate adequately
- Not having psychiatric problems
- Volunteering to participate in research
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Self-AcupressureAcupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body. | Other | Self-Acupressure |
Primary outcome
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 1. week
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 4. week
The conventional MSFC battery (MSFC3), comprising the 25 foot timed walk test (TWT), 9-hole peg test (9HPT) and paced auditory serial addition test (PASAT) was performed according to standardised procedures, calculated according to the standard manual, and normalised to this cohort.
Multiple Sclerosis Quality of Life Scale-54
Time frame: 1.week
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Multiple Sclerosis Quality of Life Scale-54
Time frame: 4.week
This scale was developed by Vickrey et al17 to evaluate the quality of life of patients with The scale was created by adding 18 MS-related items to SF-36 (short form). Physical and mental health composite scores are calculated, and higher scores indicate better quality of life. The Turkish version was developed by Tulek et al.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Results publication: PubMed 25946938Bastani F, Sobhani M, Emamzadeh Ghasemi HS. Effect of acupressure on fatigue in women with multiple sclerosis. Glob J Health Sci. 2015 Jan 26;7(4):375-81. doi: 10.5539/gjhs.v7n4p375.
- Individual participant dataSharing planned: No
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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.
Zülfünaz ÖZER, PhD study chair
Istanbul Sabahattin Zaim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Acupressure in people with Multiple Sclerosis, run by Istanbul Sabahattin Zaim 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multiple Sclerosis Functional Composite (MSFC) (time frame: 1. week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936555, which also lists 1 linked publication.
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 22 Jul 2021.