Clinical trial NCT06366555: The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals
Official title: The Role of Manual Twirling Acupuncture in Reducing Biceps Brachii Muscle Pain and Stiffness After Weight Training in Healthy Untrained Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Stiffness of Elbow, Not Elsewhere Classified
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 0,24hours,48 hours, 72 hours
Secondary outcomes:
measure: Pain Pressure Threshold
timeFrame: 0,24hours,48 hours, 72 hours
Other outcomes:
measure: Range of Motion
timeFrame: 0,24hours,48 hours, 72 hours
Locations:
city: Jakarta
country: Indonesia
facility: Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: