Scar TissueNCT06033430
Effectiveness of Dry Needling in Linear Scar Tissue
A study testing True dry needling in people with Scar Tissue and Hypertrophic Scar, run by Iran University of Medical Sciences at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Scar Tissue, Hypertrophic Scar, Hypertrophic Scar of Upper Arm (Disorder)
- What is being tested?
- True dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Oct 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Myopain Seminars
Bethesda, Maryland, 20814-4522
Jan Dommerholt, DPT, 855-209-1832, jan@myopain4u.com
Iran1 site, 1 recruiting
- Recruiting
School of Rehabilitation Sciences, Iran University of Medical Sciences
Tehran, P.O. Box 4391-15875
Mohammadreza Pourahmadi, Ph.D., Postdoc Research Fellow, +989122245593, pourahmadipt@gmail.com
About this study
Official title: The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial
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.
Read the 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
- Being tested
- True dry needling, Sham dry needling
- Keywords
- Hypertrophic scar, Dry needling, Randomized sham-controlled trial
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True dry needlingOther
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 needlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To assess joint active and passive range of motion, a 360-degree universal goniometer will be used. This involves correctly positioning and stabilizing the joint, moving the body part through its appropriate range of motion, determining the joint's end of the range and its end-feel, palpating the relevant bony landmarks, aligning the goniometer with these landmarks, and accurately reading the measuring instrument. Each measurement will be repeated three times, and the average of these repetitions will be used for statistical analysis.
Measured: 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
If pain is present in the scar region, the Numeric Pain Rating Scale (NPRS) will be employed to assess pain intensity. This scale, ranging from 0 (indicating no pain) to 10 (representing the most severe pain imaginable), will be used for rating by participants during the evaluation. The NPRS is a pain assessment tool commonly utilized in research. In this study, a minimum clinically significant difference of 0.2 will be considered.
Measured: 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
Following dry needling, the assessment of health status will be conducted using the SF-36 questionnaire, which includes 36 questions related to an individual's quality of life. This evaluation produces two summary scores: one for physical health and another for mental health.
Measured: Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start10 Oct 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Scar TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033430
- Sponsor's protocol ID
- IR.IUMS.REC.1401.540
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets of this study will be available on a reasonable request to the corresponding author.
Publications
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.
PubMed 33027765Bartsch 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.
PubMed 36646734Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/
PubMed 32644411Lubczynska 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.
PubMed 36973982Bahramian 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.
PubMed 36660004Rozenfeld 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.
PubMed 32228036Deflorin 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.
PubMed 32589450Tanaka 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.
PubMed 21437069Kurtti 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.
PubMed 33788987Klingenstein 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.
PubMed 35366138O'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.
PubMed 34290886Pourahmadi M, Dommerholt J, Ahmadi M, Schleip R, Farrohi A. Scar dry needling for tissue compliance in individuals with linear scars: a randomized controlled trial. J Man Manip Ther. 2026 Sep 10:1-12. doi: 10.1080/10669817.2026.2730521. Online ahead of print.
PubMed 42723368
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT06033430
- Acronym / sponsor ID
- IR.IUMS.REC.1401.540
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True dry needling of the hypertrophic scar tissue | Experimental | Other: True dry needlingParticipants 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. |
| Sham dry needling of the hypertrophic scar tissue | Sham comparator | Other: Sham dry needlingIn 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Needle phobia
- Immature scar or keloid scar
- Skin diseases or infections near the scar tissue
- Diabetes
- Fractures that have altered joint mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True dry needlingPrior 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 | True dry needling of the hypertrophic scar tissue |
| Sham dry needlingThe 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. | Other | Sham dry needling of the hypertrophic scar tissue |
Primary outcome
Flexibility of the scar tissue (tissue compliance)
Time frame: 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
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.
3 secondary outcomes
Active and passive joint range of motion
Time frame: 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
Time frame: 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
Time frame: Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 33027765Alaei 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.
- Background: PubMed 36646734Bartsch 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.
- Background: PubMed 32644411Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/
- Background: PubMed 36973982Lubczynska 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.
- Background: PubMed 36660004Bahramian 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.
- Background: PubMed 32228036Rozenfeld 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.
- Background: PubMed 32589450Deflorin 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.
- Background: PubMed 21437069Tanaka 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.
- Background: PubMed 33788987Kurtti 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.
- Background: PubMed 35366138Klingenstein 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.
- Background: PubMed 34290886O'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.
- Derived from this study: PubMed 42723368Pourahmadi M, Dommerholt J, Ahmadi M, Schleip R, Farrohi A. Scar dry needling for tissue compliance in individuals with linear scars: a randomized controlled trial. J Man Manip Ther. 2026 Sep 10:1-12. doi: 10.1080/10669817.2026.2730521. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data sets of this study will be available on a reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True dry needling in people with Scar Tissue and Hypertrophic Scar, run by Iran University of Medical Sciences at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow (+989122245593, pourahmadipt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flexibility of the scar tissue (tissue compliance) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033430, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.