Muscle SorenessNCT06366555
The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals
A study testing Manual Acupuncture Twirling, in people with Muscle Soreness and Stiffness of Elbow, Not Elsewhere Classified, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness, Stiffness of Elbow, Not Elsewhere Classified
- What is being tested?
- Manual Acupuncture Twirling,
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Apr 2024to 22 Jun 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Individuals with no exercise program
- Elligible for physical exercise
- Willing to take part in the study and sign informed consent
Who cannot join
- Consuming anti-inflammatory drugs, muscle relaxants and received any type of acupuncture within 7 days before the study
- Having contraindications of manual acupuncture (Pregnant, malignancy, bleeding disorders, needle phobia)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower
Jakarta, DKI Jakarta, 10430
About this study
Official title: The Role of Manual Twirling Acupuncture in Reducing Biceps Brachii Muscle Pain and Stiffness After Weight Training in Healthy Untrained Individuals
Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .
That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training
Read the detailed description
This is a clinical trial study with cross-over design with 1 week wash out period to evaluate and compare the effects of Manual Acupuncture twirling and Manual Acupuncture sham for pain and stiffness after Biceps Curling (Weight Training) on healthy untrained subjects. The subjects are 48 males/female and will be randomly assigned to 2 groups: (1) Manual Acupuncture Twirling/Manual Acupuncture Sham and (2) Manual Acupuncture Sham/Manual Acupuncture twirling group . The subjects will receive two times treatment on day 1 and day 7. The outcome will be assessed each before treatment (baseline) at 24 hours, 48 hours, and 72 hours post weight training. Patients and the outcome assessors will be blinded to the group allocation.
- Being tested
- Manual Acupuncture Twirling,, Manual Acupuncture Sham
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Acupuncture Twirling,Procedure or surgery
Manual Acupuncture twirling : using 0.14x 25 mm needle, punctured and penetrated the skin and then a twirling manipulation is carried out, 180 degrees, 3 rad/second, for 30 second each at LU5 and PC2. The needles retained for 20 minutes and manipulated at 0 minutes and 10 minutes.
Manual Acupuncture ShamProcedure or surgery
Manual Acupuncture Sham : Using 0.14x25mm needles on plesterin without being penetrated into skin and no manipulation given, retained for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Manual acupuncture twirling | Experimental | In the intervention group, acupuncture needles were inserted using a tube with manipulation parameters, puncture is carried out using a sized needle 0.14 x 25 mm penetrates the plaster and skin with using the help of a 30 mm long tube to achieve a puncture depth of 20 mm and a twirling manipulation is carried out. For kinematic parameters of rotational movement in the same direction clockwise (to the right) by 180 degrees, 3 rad/s for 30 seconds at points PC2 and LU5.
The time parameters were retained for 20 minutes and twirling was manipulated 0 minutes and 10 minutes. After the retention is over, control the bleeding with Press on the needle insertion point for 10 seconds or until the bleeding stops Receives: Procedure: Manual Acupuncture Twirling, |
| Manual acupuncture sham | Sham comparator | in the sham group acupuncture needles were inserted using a tube without any manipulation parameters and not penetrating the skin. The needles then left for 20 minutes. Receives: Procedure: Manual Acupuncture Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Subjective Pain rated by score , Minimum Value 0, Maximum Value 10. 0 : No Pain, 10 : The Worst Pain Possible
Measured: 0,24hours,48 hours, 72 hours
Secondary outcomes (1)
Pain Pressure Threshold
Objective Pain
Measured: 0,24hours,48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start22 Apr 2024
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects. The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray Sirvel, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366555
- Sponsor's protocol ID
- 24-02-0268
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Manual Twirling Acupuncture in Reducing Biceps Brachii Muscle Pain and Stiffness After Weight Training in Healthy Untrained Individuals
- ClinicalTrials.gov ID
- NCT06366555
- Acronym / sponsor ID
- 24-02-0268
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 16 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.
Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .
That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training
Detailed description
This is a clinical trial study with cross-over design with 1 week wash out period to evaluate and compare the effects of Manual Acupuncture twirling and Manual Acupuncture sham for pain and stiffness after Biceps Curling (Weight Training) on healthy untrained subjects. The subjects are 48 males/female and will be randomly assigned to 2 groups: (1) Manual Acupuncture Twirling/Manual Acupuncture Sham and (2) Manual Acupuncture Sham/Manual Acupuncture twirling group . The subjects will receive two times treatment on day 1 and day 7. The outcome will be assessed each before treatment (baseline) at 24 hours, 48 hours, and 72 hours post weight training. Patients and the outcome assessors will be blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects. The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling
| Arm | Type | Receives |
|---|---|---|
| Manual acupuncture twirling | Experimental | Procedure: Manual Acupuncture Twirling,In the intervention group, acupuncture needles were inserted using a tube with manipulation parameters, puncture is carried out using a sized needle 0.14 x 25 mm penetrates the plaster and skin with using the help of a 30 mm long tube to achieve a puncture depth of 20 mm and a twirling manipulation is carried out. For kinematic parameters of rotational movement in the same direction clockwise (to the right) by 180 degrees, 3 rad/s for 30 seconds at points PC2 and LU5. The time parameters were retained for 20 minutes and twirling was manipulated 0 minutes and 10 minutes. After the retention is over, control the bleeding with Press on the needle insertion point for 10 seconds or until the bleeding stops |
| Manual acupuncture sham | Sham comparator | Procedure: Manual Acupuncture Shamin the sham group acupuncture needles were inserted using a tube without any manipulation parameters and not penetrating the skin. The needles then left for 20 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Individuals with no exercise program
- Elligible for physical exercise
- Willing to take part in the study and sign informed consent
Key exclusion criteria (2 listed)
- Consuming anti-inflammatory drugs, muscle relaxants and received any type of acupuncture within 7 days before the study
- Having contraindications of manual acupuncture (Pregnant, malignancy, bleeding disorders, needle phobia)
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 |
|---|---|---|
| Manual Acupuncture Twirling,Manual Acupuncture twirling : using 0.14x 25 mm needle, punctured and penetrated the skin and then a twirling manipulation is carried out, 180 degrees, 3 rad/second, for 30 second each at LU5 and PC2. The needles retained for 20 minutes and manipulated at 0 minutes and 10 minutes. | Procedure or surgery | Manual acupuncture twirling |
| Manual Acupuncture ShamManual Acupuncture Sham : Using 0.14x25mm needles on plesterin without being penetrated into skin and no manipulation given, retained for 20 minutes | Procedure or surgery | Manual acupuncture sham |
Primary outcome
Visual Analog Scale
Time frame: 0,24hours,48 hours, 72 hours
Subjective Pain rated by score , Minimum Value 0, Maximum Value 10. 0 : No Pain, 10 : The Worst Pain Possible
1 secondary outcome
Pain Pressure Threshold
Time frame: 0,24hours,48 hours, 72 hours
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 25 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture Twirling, in people with Muscle Soreness and Stiffness of Elbow, Not Elsewhere Classified, 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 3 inclusion and 2 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 25 Jun 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 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?
Visual Analog Scale (time frame: 0,24hours,48 hours, 72 hours). 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 25 Jun 2024.