NCT04960150

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

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

June 23, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

11 days

First QC Date

June 23, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

acupuncturepress tack needleleg strength

Outcome Measures

Primary Outcomes (2)

  • Leg muscle strength

    Measurement of leg muscle strength before the intervention, and compared between the two groups

    baseline (Before intervention)

  • Leg muscle strength

    Measurement of leg muscle strength after the intervention, and compared between the two groups

    35 minutes after intervention

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Intervention of press tack needle acupuncture

Device: Press tack needle

Control group

PLACEBO COMPARATOR

Intervention of placebo acupuncture

Device: Plesterin

Interventions

Press tack needle acupuncture using "Seirin Pyonex" sized 0.20x1.2mm

Acupuncture group
PlesterinDEVICE

Plesterin

Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • absence or refusal to be examined and not cooperative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Science Faculty, Universitas Negeri Jakarta

Jakarta, Indonesia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 13, 2021

Study Start

August 4, 2021

Primary Completion

August 15, 2021

Study Completion

September 10, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations