Effectiveness of Dry Needling in Linear Scar Tissue

NCT06033430 | Unknown DMC

• 1 other identifier: IR.IUMS.REC.1401.540
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Flexibility of the scar tissue (tissue compliance)

  The Tissue Compliance Meter (STCM), created by the Technical University of Chemnitz in Germany, is a straightforward tool for measuring tissue compliance. It consists of a ruler with millimeter markings, attached to a standard algometer from Greenwich, CT, USA. It also includes two additional components: a round plastic disk with a metal cylinder and a ring with a screw for securing them in place. These disk and ring components can be adjusted along the ruler. A button cell battery is used to generate a beep when the ring and disk touch each other. To take a measurement, the investigator pushes the top of the algometer into the tissue until it reaches displacements of 0.5, 1, and 1.5 centimeters on the scar tissue. The investigator then records the applied force in either kilograms or Newtons, depending on the pre-set displacement. Each measurement is repeated three times, and the average of these three repetitions is used for statistical analysis.

  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 (3)

• Active and passive joint range of motion

  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

• Pain intensity

  Change in pain after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up

• Health-related quality of life

  Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up

Study Arms (2)

True dry needling of the hypertrophic scar tissue

EXPERIMENTAL

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.

Other: True dry needling

Sham dry needling of the hypertrophic scar tissue

SHAM COMPARATOR

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.

Other: Sham dry needling

Interventions

True dry needling OTHER

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.

True dry needling of the hypertrophic scar tissue

Sham dry needling OTHER

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.

Sham dry needling of the hypertrophic scar tissue

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (2)

Myopain Seminars

Bethesda, Maryland, 20814-4522, United States

RECRUITING

School of Rehabilitation Sciences, Iran University of Medical Sciences

Tehran, P.O. Box 4391-15875, Iran

RECRUITING

Related Publications (11)

• 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.

  PMID: 33027765 BACKGROUND

• 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.

  PMID: 36646734 BACKGROUND

• 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/

  PMID: 32644411 BACKGROUND

• 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.

  PMID: 36973982 BACKGROUND

• 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.

  PMID: 36660004 BACKGROUND

• 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.

  PMID: 32228036 BACKGROUND

• 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.

  PMID: 32589450 BACKGROUND

• 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.

  PMID: 21437069 BACKGROUND

• 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.

  PMID: 33788987 BACKGROUND

• 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.

  PMID: 35366138 BACKGROUND

• 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.

  PMID: 34290886 BACKGROUND

Related Links

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MeSH Terms

Conditions

Cicatrix; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow

CONTACT

+989122245593; pourahmadipt@gmail.com

Maryam Ahmadi, Ms.c.

CONTACT

+989106665134; maryamahmadima226@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the control group will undergo the same procedure as those in the intervention group, with needles placed superficially in an area slightly further away from the scar tissue. Furthermore, to minimize bias, the data analyst will be blinded to the grouping of the participants, and each participant will be identified by a unique numerical code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 10, 2023
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after the publication.

Locations

IR (1); US (1)