RESEARCH OBJECTIVE:
The primary objective of this study is to investigate the effectiveness of dry needling
on hypertrophic scar tissue compliance using a compliance meter. The secondary objectives
of the study are to evaluate active and passive range of motion, pain, and functional
disability.
RESEARCH DESIGN:
This study is a two-centered, randomized, single-blind, sham-controlled trial with an
allocation ratio of 1:1. Eighty participants with hypertrophic scar tissue will be
randomly assigned into two groups with equal sample size. Random allocation will be
performed using the permuted block randomization method, consisting of four-letter blocks
made of letters A and B. The random treatment list obtained at the end of the random
allocation task will be placed in letters A and B inside sealed and numbered envelopes.
The random assignment process will be performed by someone outside the research team
before the study begins.
PROCEDURE:
Eligible participants will be asked to complete an intake form providing demographic data
such as age, gender, height, weight, occupation, and questions related to their scar
tissue (onset, injury mechanism, location, duration, and whether it causes pain). The
principal investigator will confirm each participant's eligibility. Next, each
participant will complete a pain and functional disability questionnaire. After gathering
subjective information, tissue compliance data and active and passive range of motion
near the nearest joint next to the scar tissue will be collected. The outcome
measurements will be administered in an order of tissue compliance, followed by joint
active and passive range of motion.
INTERVENTION:
After the baseline assessment, the principal investigator will administer the dry
needling intervention. For the intervention group, a 2-cm sterile, disposable, solid
filament needle (Dongbang Acupuncture Needle, Korea) will be manually inserted at an
angle of approximately 15 degrees to the skin surface into the scar tissue. The needle
will then be rotated to separate the tissue adhesions along the path of the scar tissue.
In the sham dry needling treatment group, the patient's condition will be identical to
that of the real dry needling treatment group, with a minor exception. Instead of
inserting the 2-cm single-use sterile filiform acupuncture needle into the scar tissue,
it will be superficially inserted at a point further away from the scar tissue and
removed after 20 minutes. Both groups will receive basic routine treatment, including
kinesiology taping, along with infrared therapy (for 20 minutes) at a distance of 30 cm
from the scar tissue. The patients will undergo six treatment sessions, with three
sessions per week for two weeks.
REASSESSMENT:
After the interventions, measures of the primary and secondary outcomes will be collected
immediately and two weeks after the final treatment session to evaluate the effectiveness
of the dry needling intervention. Additionally, any adverse events following the dry
needling procedures will be assessed immediately, such as bruising, nausea, dizziness, or
post-needling soreness. If bleeding occurs, the participant will be informed.