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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06033430




Registration number
NCT06033430
Ethics application status
Date submitted
5/09/2023
Date registered
13/09/2023

Titles & IDs
Public title
Effectiveness of Dry Needling in Linear Scar Tissue
Scientific title
The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial
Secondary ID [1] 0 0
IR.IUMS.REC.1401.540
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scar Tissue 0 0
Hypertrophic Scar 0 0
Hypertrophic Scar of Upper Arm (Disorder) 0 0
Hypertrophic Surgical Scar 0 0
Dry Needling 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - True dry needling
Other interventions - Sham dry needling

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.


Other 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Flexibility of the scar tissue (tissue compliance)
Timepoint [1] 0 0
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 outcome [1] 0 0
Active and passive joint range of motion
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Pain intensity
Timepoint [2] 0 0
Change in pain after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
Secondary outcome [3] 0 0
Health-related quality of life
Timepoint [3] 0 0
Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up

Eligibility
Key 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
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
Iran, Islamic Republic of
State/province [2] 0 0
Tehran

Funding & Sponsors
Primary sponsor type
Other
Name
Iran University of Medical Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mohammadreza Pourahmadi, Ph.D. Postdoc research fellow
Address 0 0
Country 0 0
Phone 0 0
+989122245593
Fax 0 0
Email 0 0
pourahmadipt@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sets of this study will be available on a reasonable request to the corresponding author.
When will data be available (start and end dates)?
Starting 6 months after the publication.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06033430