NCT06033430

Effectiveness of Dry Needling in Linear Scar Tissue

The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Iran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scar Tissue
• Hypertrophic Scar
• Hypertrophic Scar of Upper Arm (Disorder)
• Hypertrophic Surgical Scar
• Dry Needling

Interventions

Type	Name	Description
OTHER	True dry needling	Prior to the procedure, participants will be given a detailed explanation of the dry needling technique. Afterward, the specific area will be thoroughly cleaned using an alcohol pad. In the true dry needling group, along with routine physiotherapy, a sterile filiform acupuncture needle, measuring 2 cm in length and designed for single-use, will be inserted at a 15-degree angle relative to the skin's surface, directly into the scar tissue. Once inserted, the needle will be gently rotated to aid in separating tissue adhesions along the path of the scar. Routine physiotherapy includes the application of kinesiology taping, in addition to a 20-minute session of infrared therapy positioned 30 cm away from the scar tissue. A total of six treatment sessions will be administered to the patients, with three sessions per week scheduled over a two-week period.
OTHER	Sham dry needling	The sham group participants will be positioned in a similar manner to those in the experimental 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. Moreover, routine physiotherapy administered to the participants in the sham group will be identical to that of the experimental group, ensuring consistency between the two groups.

Timeline

• Start date: 2023-10-10
• Primary completion: 2024-11-01
• Completion: 2025-06-01
• First posted: 2023-09-13
• Last updated: 2024-10-01

Locations

2 sites across 2 countries: United States, Iran