Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-10-10
2025-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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True dry needling of the hypertrophic scar tissue
Participants with hypertrophic linear scar tissue in the true dry needling group will undergo authentic dry needling interventions targeted at the scar tissue, in conjunction with routine physiotherapy.
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.
Sham dry needling of the hypertrophic scar tissue
In the sham dry needling group, participants presenting with hypertrophic linear scar tissue will receive superficial dry needling of the skin, performed at a location distinct from the scar tissue. This will be administered alongside routine physiotherapy.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* No restrictions on active and passive joint range of motion near the scar tissue
* Age between 20 and 60 years
Exclusion Criteria
* Immature scar or keloid scar
* Skin diseases or infections near the scar tissue
* Diabetes
* Fractures that have altered joint mobility
* Anticoagulant medication use
20 Years
60 Years
ALL
No
Sponsors
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Iran University of Medical Sciences
OTHER
Responsible Party
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Locations
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Myopain Seminars
Bethesda, Maryland, United States
School of Rehabilitation Sciences, Iran University of Medical Sciences
Tehran, , Iran
Countries
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Central Contacts
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Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow
Role: CONTACT
Facility Contacts
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Mohammadreza Pourahmadi, Ph.D., Postdoc Research Fellow
Role: primary
References
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Alaei P, Nakhostin Ansari N, Naghdi S, Fakhari Z, Komesh S, Dommerholt J. Dry Needling for Hamstring Flexibility: A Single-Blind Randomized Controlled Trial. J Sport Rehabil. 2020 Oct 7;30(3):452-457. doi: 10.1123/jsr.2020-0111.
Bartsch K, Brandl A, Weber P, Wilke J, Bensamoun SF, Bauermeister W, Klingler W, Schleip R. Assessing reliability and validity of different stiffness measurement tools on a multi-layered phantom tissue model. Sci Rep. 2023 Jan 16;13(1):815. doi: 10.1038/s41598-023-27742-w.
Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/
Lubczynska A, Garncarczyk A, Wcislo-Dziadecka D. Effectiveness of various methods of manual scar therapy. Skin Res Technol. 2023 Mar;29(3):e13272. doi: 10.1111/srt.13272.
Bahramian M, Dabbaghipour N, Aria A, Sajadi Moghadam Fard Tehrani B, Dommerholt J. Efficacy of Dry Needling in Treating Scars following Total Hip Arthroplasty: A Case Report. Med J Islam Repub Iran. 2022 Dec 20;36:156. doi: 10.47176/mjiri.36.156. eCollection 2022.
Rozenfeld E, Sapoznikov Sebakhutu E, Krieger Y, Kalichman L. Dry needling for scar treatment. Acupunct Med. 2020 Dec;38(6):435-439. doi: 10.1177/0964528420912255. Epub 2020 Mar 30.
Deflorin C, Hohenauer E, Stoop R, van Daele U, Clijsen R, Taeymans J. Physical Management of Scar Tissue: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2020 Oct;26(10):854-865. doi: 10.1089/acm.2020.0109. Epub 2020 Jun 24.
Tanaka Y, Matsuo K, Yuzuriha S. Long-term histological comparison between near-infrared irradiated skin and scar tissues. Clin Cosmet Investig Dermatol. 2010 Nov 25;3:143-9. doi: 10.2147/CCID.S15729.
Kurtti A, Nguyen JK, Weedon J, Mamalis A, Lai Y, Masub N, Geisler A, Siegel DM, Jagdeo JR. Light emitting diode-red light for reduction of post-surgical scarring: Results from a dose-ranging, split-face, randomized controlled trial. J Biophotonics. 2021 Jul;14(7):e202100073. doi: 10.1002/jbio.202100073. Epub 2021 May 4.
Klingenstein A, Garip-Kuebler A, Muth DR, Hintschich C. A prospective randomized pilot study evaluating the scar outcome after gluteal dermis fat graft with and without kinesiotaping. Int Ophthalmol. 2022 Aug;42(8):2563-2571. doi: 10.1007/s10792-022-02304-7. Epub 2022 Apr 2.
O'Reilly S, Crofton E, Brown J, Strong J, Ziviani J. Use of tape for the management of hypertrophic scar development: A comprehensive review. Scars Burn Heal. 2021 Jul 12;7:20595131211029206. doi: 10.1177/20595131211029206. eCollection 2021 Jan-Dec.
Related Links
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Other Identifiers
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IR.IUMS.REC.1401.540
Identifier Type: -
Identifier Source: org_study_id
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