Health, SubjectiveNCT04960150
EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH
A study testing Press tack needle and Plesterin in people with Health, Subjective and Muscle Strength, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Press tack needle is one of the acupuncture modalities in the form of needles that are attached to the skin, and can be left attached to the skin for several days which makes its use much easier than conventional acupuncture. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Muscle Strength
- What is being tested?
- Press tack needle and Plesterin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Aug 2021to 10 Sep 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- willingness to fill out an informed consent form;
- age between 18-25 years;
- male;
- has a BMI value of 18.5-22.9 kg/m2;
- there is no history of injury or history of surgery on the lower extremities in the last three months;
- the individual is in good health.
Who cannot join
- absence or refusal to be examined and not cooperative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH: RANDOMIZED CONTROLLED TRIAL IN SPORTS STUDENTS
Press tack needle is one of the acupuncture modalities in the form of needles that are attached to the skin, and can be left attached to the skin for several days which makes its use much easier than conventional acupuncture.
The purpose of this study was to determine how the effect of press tack needle acupuncture on leg muscle strength performed on sports students.
Research subjects as many as 30 people were randomized into two groups, namely the intervention group and the control group. In the intervention group, acupuncture treatment was performed with a press tack needle at acupuncture points on the legs. The leg muscle strength was measured using a leg dynamometer before and after the acupuncture intervention. Analyzed the difference in mean leg muscle strength before and after the intervention, and between the two groups.
- Conditions
- Health, Subjective, Muscle Strength
- Being tested
- Press tack needle, Plesterin
- Keywords
- acupuncture, press tack needle, leg strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press tack needleDevice
Press tack needle acupuncture using "Seirin Pyonex" sized 0.20x1.2mm
PlesterinDevice
Plesterin
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Intervention of press tack needle acupuncture Receives: Device: Press tack needle |
| Control group | Placebo comparator | Intervention of placebo acupuncture Receives: Device: Plesterin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg muscle strength
Measurement of leg muscle strength before the intervention, and compared between the two groups
Measured: baseline (Before intervention)
Leg muscle strength
Measurement of leg muscle strength after the intervention, and compared between the two groups
Measured: 35 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start4 Aug 2021
- Primary completion15 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wahyuningsih Djaali, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960150
- Sponsor's protocol ID
- 21-05-0541
- Status last verified
- Oct 2021
- First submitted
- 23 Jun 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH: RANDOMIZED CONTROLLED TRIAL IN SPORTS STUDENTS
- ClinicalTrials.gov ID
- NCT04960150
- Acronym / sponsor ID
- 21-05-0541
- Conditions
- Health, Subjective, Muscle Strength
- Keywords
- acupuncture, press tack needle, leg strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 13 Jul 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.
Press tack needle is one of the acupuncture modalities in the form of needles that are attached to the skin, and can be left attached to the skin for several days which makes its use much easier than conventional acupuncture.
The purpose of this study was to determine how the effect of press tack needle acupuncture on leg muscle strength performed on sports students.
Research subjects as many as 30 people were randomized into two groups, namely the intervention group and the control group. In the intervention group, acupuncture treatment was performed with a press tack needle at acupuncture points on the legs. The leg muscle strength was measured using a leg dynamometer before and after the acupuncture intervention. Analyzed the difference in mean leg muscle strength before and after the intervention, and between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: Press tack needleIntervention of press tack needle acupuncture |
| Control group | Placebo comparator | Device: PlesterinIntervention of placebo acupuncture |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- willingness to fill out an informed consent form;
- age between 18-25 years;
- male;
- has a BMI value of 18.5-22.9 kg/m2;
- there is no history of injury or history of surgery on the lower extremities in the last three months;
Key exclusion criteria (1 listed)
- absence or refusal to be examined and not cooperative.
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 |
|---|---|---|
| Press tack needlePress tack needle acupuncture using "Seirin Pyonex" sized 0.20x1.2mm | Device | Acupuncture group |
| PlesterinPlesterin | Device | Control group |
Primary outcome
Leg muscle strength
Time frame: baseline (Before intervention)
Measurement of leg muscle strength before the intervention, and compared between the two groups
Leg muscle strength
Time frame: 35 minutes after intervention
Measurement of leg muscle strength after the intervention, and compared between the two groups
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 15 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Health, Subjective
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Recruiting
Florida Community-Engaged Research Alliance (FL-CEAL)
Health, Subjective
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 Press tack needle and Plesterin in people with Health, Subjective and Muscle Strength, run by Universitas Indonesia at 1 site in Indonesia.
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 6 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 15 Oct 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Leg muscle strength (time frame: baseline (Before intervention)). The study lists 2 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 15 Oct 2021.