Clinical trial NCT06033430: Effectiveness of Dry Needling in Linear Scar Tissue
Official title: The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scar Tissue
Hypertrophic Scar
Hypertrophic Scar of Upper Arm (Disorder)
Hypertrophic Surgical Scar
Dry Needling
Keywords: Hypertrophic scar
Dry needling
Randomized sham-controlled trial
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scar tissue can cause serious complications that significantly impact a patient's quality of life. Common complications include stiffness and contractions, which can restrict joint mobility and make daily activities challenging. In severe cases, these limitations can even prevent patients from fulfilling their work responsibilities or engaging in activities they enjoy. The deleterious effect of scar tissue on a patient's well-being is of utmost significance. However, several therapeutic approaches have been proposed to manage scar tissue complications. Enhancing scar tissue compliance can help patients regain their functional abilities and reduce limitations. One such approach is dry needling, a technique used to improve the flexibility of myofascial tightness. Nevertheless, the effectiveness of dry needling in improving scar tissue compliance remains debatable. Therefore, this study aims to investigate the therapeutic effects of dry needling on complications resulting from linear hypertrophic scars caused by surgery or trauma.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Linear hypertrophic scar tissue with an age of more than six weeks
* No restrictions on active and passive joint range of motion near the scar tissue
* Age between 20 and 60 years

Exclusion Criteria:

* Needle phobia
* Immature scar or keloid scar
* Skin diseases or infections near the scar tissue
* Diabetes
* Fractures that have altered joint mobility
* Anticoagulant medication use

Primary outcomes:
measure: Flexibility of the scar tissue (tissue compliance)
timeFrame: Change in flexibility of the scar tissue after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
Secondary outcomes:
measure: Active and passive joint range of motion
timeFrame: Change in joint range of motion after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
measure: Pain intensity
timeFrame: Change in pain after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
measure: Health-related quality of life
timeFrame: Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Myopain Seminars
state: Maryland
city: Tehran
country: Iran, Islamic Republic of
facility: School of Rehabilitation Sciences, Iran University of Medical Sciences
Study officials:
References:
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