NCT06366555

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

April 11, 2024

Last Update Submit

June 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain Pressure Threshold

    0,24hours,48 hours, 72 hours

Other Outcomes (1)

  • Range of Motion

    0,24hours,48 hours, 72 hours

Study Arms (2)

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

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.

Procedure: Manual Acupuncture Sham

Interventions

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 twirling

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

Manual acupuncture sham

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Individuals with no exercise program
  • Elligible for physical exercise
  • Willing to take part in the study and sign informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KEPK FKUI-RSCM

    The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The Participant will be randomized using a computerized table and the Outcome Assessor dont know which Subjects receive the manual acupuncture twirling or sham manual acupuncture on each period
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

April 22, 2024

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations