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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06366555
Other study ID # 24-02-0268
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 22, 2024
Est. completion date June 22, 2024

Study information

Verified date April 2024
Source Indonesia University
Contact Ray Sirvel, Doctor
Phone +6287781518905
Email dr.raysirvel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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 30 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 22, 2024
Est. primary completion date June 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy Individuals with no exercise program - Elligible for physical exercise - Willing to take part in the study and sign informed consent Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Manual Acupuncture Sham
Manual Acupuncture Sham : Using 0.14x25mm needles on plesterin without being penetrated into skin and no manipulation given, retained for 20 minutes

Locations

Country Name City State
Indonesia Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Other Range of Motion Range of Elbow Flexor Extension 0,24hours,48 hours, 72 hours
Primary Visual Analog Scale Subjective Pain rated by score , Minimum Value 0, Maximum Value 10. 0 : No Pain, 10 : The Worst Pain Possible 0,24hours,48 hours, 72 hours
Secondary Pain Pressure Threshold Objective Pain 0,24hours,48 hours, 72 hours
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