Dry Needling for Scars

Recruiting at 2 trial locations

Overseen By Maryam Ahmadi, Ms.c.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Iran University of Medical Sciences

Must not be taking: Anticoagulants

Disqualifiers: Needle phobia, Immature scar, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dry needling can improve flexibility in tight and raised scar tissue, known as hypertrophic scars, after surgery or injury. The researchers aim to determine if dry needling can reduce stiffness and ease everyday activities. Participants will receive either true dry needling, which involves inserting thin needles directly into the scar, or a sham version elsewhere on the skin, along with regular physiotherapy. Individuals with linear hypertrophic scars present for over six weeks that do not restrict joint movement might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for enhancing scar flexibility.

Will I have to stop taking my current medications?

If you are taking anticoagulant medications (blood thinners), you will need to stop them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dry needling is generally well-tolerated by patients. Studies have found it effective for treating scars and improving movement. Most reports indicate that dry needling achieves the desired results in scar treatment, although the strength of the evidence varies. Some case studies specifically mention quick pain relief and better movement in scarred areas after treatment.

While questions about its overall safety exist, the risks are considered low. The available research has not reported any major negative effects. Overall, dry needling appears to be a safe option for those looking to improve issues with scar tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dry needling for hypertrophic scar treatment because it offers a unique approach compared to existing options like silicone gel sheets or corticosteroid injections. Unlike these conventional therapies, which primarily aim to flatten or reduce scar tissue, dry needling directly targets the scar tissue by stimulating the body's natural healing processes. This technique could potentially enhance tissue remodeling and improve scar appearance without the side effects often associated with more invasive treatments. Additionally, the combination of dry needling with routine physiotherapy might further optimize healing and functional outcomes, presenting a promising alternative for individuals seeking effective scar management.

What evidence suggests that dry needling is effective for improving scar tissue compliance?

Research has shown that dry needling can increase scar flexibility. In this trial, participants will join different treatment arms to assess dry needling's effects on hypertrophic scar tissue. One group will receive true dry needling, which earlier studies demonstrated can quickly reduce pain and improve movement in scarred areas. Another group will receive sham dry needling, involving superficial needling at a location away from the scar tissue. Although more research is needed, these early findings suggest dry needling might alleviate scar-related issues. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-60 with linear hypertrophic scars older than six weeks, without joint movement restrictions near the scar. It's not suitable for those with a fear of needles, diabetes, keloid scars, skin infections near the scar tissue, altered joint mobility due to fractures or those on anticoagulant medications.

Inclusion Criteria

I have a scar that is raised and older than six weeks.

I can move my joints freely near my scar.

I am between 20 and 60 years old.

Exclusion Criteria

I am taking blood thinner medications.

I have skin conditions or infections near my scar.

I have had fractures that changed how my joints move.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive dry needling or sham treatment along with routine physiotherapy for scar tissue

2 weeks

6 visits (in-person)

Reassessment

Measures of primary and secondary outcomes are collected immediately and two weeks after the final treatment session

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in health status, flexibility, range of motion, and pain intensity

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sham dry needling
• True dry needling

Trial Overview The study tests dry needling's effectiveness on improving flexibility and reducing complications from surgery or trauma-induced linear hypertrophic scars. Participants will receive either true dry needling or sham (fake) treatment to compare outcomes.

How Is the Trial Designed?

Group I: True dry needling of the hypertrophic scar tissue Experimental Treatment 1 Intervention

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.

Group II: Sham dry needling of the hypertrophic scar tissue Placebo Group 1 Intervention

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 is already approved in United States, European Union for the following indications:

Approved in United States as Dry Needling for:

• Musculoskeletal pain
• Myofascial pain syndrome
• Chronic pain
• Low back pain
• Strains
• Osteoarthritis
• Fibromyalgia
• Tendinopathies

Approved in European Union as Dry Needling for:

• Musculoskeletal pain
• Myofascial pain syndrome
• Chronic pain
• Low back pain
• Strains
• Osteoarthritis
• Fibromyalgia
• Tendinopathies

Who Is Running the Clinical Trial?

Iran University of Medical Sciences

Lead Sponsor

Trials

30

Recruited

2,000+

Published Research Related to This Trial

Myofascial trigger points are linked to various systemic and psychological factors, making it essential for clinicians to thoroughly screen patients for underlying conditions before using dry needling as a treatment.

Clinicians should be aware of specific medical conditions and comorbidities that could affect the safety and efficacy of dry needling, including those that may present with similar symptoms to musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives on dry needling following a medical model: are we screening our patients sufficiently? Kearns, G., Fernández-De-Las-Peñas, C., Brismée, JM., et al.[2020]

In a study involving 39 physiotherapists and 7629 treatments, trigger point dry needling (TrP-DN) was found to have a high incidence of mild adverse events (AEs), with 1463 reported cases, but no significant AEs occurred, indicating a very low risk of serious complications (≤ 0.04%).

Common mild AEs included bruising (7.55%) and bleeding (4.65%), but the overall safety profile suggests that TrP-DN is a safe treatment option for myofascial pain when performed by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. Brady, S., McEvoy, J., Dommerholt, J., et al.[2022]

In a study involving nine rabbits, dry needling of myofascial trigger points significantly reduced spontaneous electrical activity (SEA) in the treated muscle, indicating its effectiveness in relieving myofascial pain.

The results suggest that eliciting local twitch responses during dry needling is crucial for reducing SEA, highlighting that this response, rather than just the needling itself, plays a key role in the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory effect of dry needling on the spontaneous electrical activity recorded from myofascial trigger spots of rabbit skeletal muscle. Chen, JT., Chung, KC., Hou, CR., et al.[2019]

In a study involving 20 asymptomatic subjects, dry needling of latent trigger points in the gastrocnemius medialis muscle resulted in a significant decrease in the electromyographic (EMG) peak activity of local twitch responses (LTRs) with each subsequent twitch, indicating a reduction in muscle hyperactivity during treatment.

Despite the decrease in LTR amplitude, there were no significant changes in the overall EMG activity at rest before and after the dry needling procedure, suggesting that while dry needling may effectively reduce localized muscle tension, it does not affect general muscle activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyographic Activity Evolution of Local Twitch Responses During Dry Needling of Latent Trigger Points in the Gastrocnemius Muscle: A Cross-Sectional Study. Baraja-Vegas, L., Martín-Rodríguez, S., Piqueras-Sanchiz, F., et al.[2021]

In a study involving 54 patients with myofascial trigger points in the upper trapezius muscle, both dry needling (DN) and DN with needle retention for 30 minutes significantly reduced pain intensity and improved pressure pain threshold after 7 and 14 days.

Despite both methods showing effectiveness in treating pain, there were no significant differences in outcomes between the two techniques, suggesting that needle retention may not provide additional benefits over standard dry needling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness between dry needling with and without needle retention in myofascial trigger points in upper trapezius muscle: A randomized comparative trial. Khanittanuphong, P., Saesim, A.[2022]

A study involving 42 healthy participants demonstrated that low-cost sham dry needles can effectively serve as a control in dry needling research, as they produced similar pain perceptions to real dry needling.

Both groups reported similar pain levels, but the quality of pain differed, indicating that the sham needles can mimic the experience of real treatment without eliciting a physiological response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Construction of Sham Dry Needles and Their Validity. Mitchell, UH., Stoneman, P., Larson, RE., et al.[2020]

Dry needling (DN) effectively reduces pain from active myofascial trigger points (a-MTrPs) with significant improvements in pain scores sustained for at least 6 weeks after treatment, as shown in a study of 45 patients with cervical pain.

Patients who experienced a greater initial reduction in pain (measured by the VAS score) were more likely to maintain their pain relief, indicating that early and significant pain reduction is crucial for long-term benefits from DN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Dry Needling for Treatment of Chronic Myofascial Pain Persist for 6 Weeks After Treatment Completion. Gerber, LH., Sikdar, S., Aredo, JV., et al.[2023]

In a study of 52 participants with Achilles tendinopathy, adding intramuscular stimulation to a 12-week rehabilitation program did not provide any additional benefit compared to rehabilitation alone or sham treatment, as measured by the VISA-A score.

All treatment groups showed improvement over time, but there were no significant differences in self-reported improvement or secondary outcomes, indicating that standard rehabilitation alone is effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular stimulation vs sham needling for the treatment of chronic midportion Achilles tendinopathy: A randomized controlled clinical trial. Solomons, L., Lee, JJY., Bruce, M., et al.[2020]

In a study of 26 participants with chronic neck pain, dry needling (DN) without eliciting a local twitch response (LTR) showed greater improvements in pain, pain pressure threshold, and cervical range of motion compared to DN with LTR after 4 weeks of treatment.

While both methods were effective, DN without LTR was found to be superior for achieving better clinical outcomes, suggesting it may be a safer option by potentially reducing the risk of muscle damage and tissue fibrosis associated with LTR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dry needling on the active trigger point of upper trapezius muscle: Eliciting local twitch response on long-term clinical outcomes. Hakim, IK., Takamjani, IE., Sarrafzadeh, J., et al.[2020]

A single session of dry needling (DN) significantly reduced sympathetic nervous system hyperactivity and improved pain intensity in patients with upper trapezius myofascial trigger points (MTrPs), indicating its efficacy as a treatment method.

After DN, patients experienced increased pressure pain thresholds and a reduction in neuromuscular junction response abnormalities, suggesting that DN effectively deactivates active MTrPs and alleviates associated symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of dry needling in patients with upper trapezius myofascial trigger points. Abbaszadeh-Amirdehi, M., Ansari, NN., Naghdi, S., et al.[2018]

In a study of 52 subjects with myofascial pain, dry needling significantly increased pain pressure thresholds compared to sham dry needling, indicating its effectiveness in relieving muscle pain.

However, there were no significant differences in pain intensity or jaw opening without pain between the two groups, suggesting that while dry needling helps with tenderness, it may not impact overall pain perception or jaw function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: a double-blind, randomized, placebo controlled study. Dıraçoğlu, D., Vural, M., Karan, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11277857/

Dry Needling and Acupuncture for Scars—A Systematic Review Most studies demonstrated a desired therapeutic effect in scar treatment with acupuncture and dry needling, but the level of evidence varied across studies.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06033430?draw=2&rank=1

Effectiveness of Dry Needling in Linear Scar Tissue Therefore, this study aims to investigate the therapeutic effects of dry needling on complications resulting from linear hypertrophic scars caused by surgery or ...

3. researchgate.net researchgate.net/publication/340309640_Dry_needling_for_scar_treatment

(PDF) Dry needling for scar treatment Two case reports have suggested that scar needling generates a rapid decrease in pain and improvement of mobility in scarred tissues. Another two case reports ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06033430/effectiveness-of-dry-needling-in-linear-scar-tissue

Effectiveness of Dry Needling in Linear Scar Tissue The primary objective of this study is to investigate the effectiveness of dry needling on hypertrophic scar tissue compliance using a ...

5. bmccomplementmedtherapies.biomedcentral.com bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-023-04301-4

Acupuncture and dry needling for physical therapy of scar The aim of this systematic review was to determine the usefulness of dry needling or local acupuncture for scar treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759514/

Acupuncture and dry needling for physical therapy of scar The aim of this systematic review was to determine the usefulness of dry needling or local acupuncture for scar treatment.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4458928/

DRY NEEDLING FOR MYOFASCIAL TRIGGER POINT PAIN Despite its efficacy and low risk, questions remain as to its effectiveness, safety, and whether the technique is within the scope of practice of physical ...

8. mdpi.com mdpi.com/2077-0383/13/14/3994

Dry Needling and Acupuncture for Scars—A Systematic ... Most studies demonstrated a desired therapeutic effect in scar treatment with acupuncture and dry needling, but the level of evidence varied across studies.