Recruiting

Dry Needling

Sponsor:

Iran University of Medical Sciences

Code:

NCT06033430

Conditions

Scar Tissue

Hypertrophic Scar

Hypertrophic Scar of Upper Arm (Disorder)

Hypertrophic Surgical Scar

Dry Needling

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Not accepted

Interventions

True dry needling

Sham dry needling

Study Details

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

Study ID

NCT06033430

Start date

Oct 10, 2023

Status verified date

Nov, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow

+989122245593pourahmadipt@gmail.com

Maryam Ahmadi, Ms.c.

+989106665134maryamahmadima226@gmail.com

Locations

Myopain Seminars

Recruiting

Bethesda, Maryland, United States, 20814-4522

Contacts

Jan Dommerholt, DPT

855-209-1832jan@myopain4u.com

More Information

Sponsor

Iran University of Medical Sciences

Last update posted

Oct 1, 2024

Last verified

Nov, 2023

Keywords

  • Hypertrophic scar
  • Dry needling
  • Randomized sham-controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Iran University of Medical Sciences on 2024-10-01.