Dry Needling for Multiple Sclerosis

Recruiting at 2 trial locations

Overseen By Abbas TABATABAEI, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Needle phobia, Pregnancy, Active cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dry needling, a treatment using tiny needles, can reduce muscle tightness and improve movement in people with Multiple Sclerosis (MS). It targets muscles such as those in the calves, aiming to ease stiffness and enhance balance and walking. Participants will receive either real dry needling or a sham version to determine any differences in outcomes. This trial suits individuals diagnosed with MS who experience muscle tightness in their legs and have had no major recent medical changes. As an unphased trial, it offers a unique opportunity to contribute to understanding potential new treatments for MS-related muscle tightness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you haven't changed any medications, including those for muscle tightness, in the past three months.

What prior data suggests that dry needling is safe for people with Multiple Sclerosis?

Research has shown that dry needling is generally safe, though it can cause minor side effects. One study found that about 36.7% of treatments led to minor issues, such as slight bleeding and soreness. These side effects are usually not serious and often resolve on their own.

Another study found that participants experienced benefits like reduced pain and improved movement after dry needling. While there are small risks, many find the treatment helpful. Considering these minor risks alongside the potential benefits is important when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dry needling for multiple sclerosis because it offers a new, non-pharmacological approach that may help manage symptoms like muscle spasticity and pain. Unlike standard treatments that often rely on medications or physical therapy, dry needling uses fine needles to target specific muscle areas, potentially leading to quicker relief. This technique could provide an alternative for those who prefer not to use medications or for whom traditional therapies haven't been fully effective.

What evidence suggests that dry needling is effective for muscle spasticity in Multiple Sclerosis?

Research has shown that dry needling, which participants in this trial may receive, can reduce muscle tightness in people with Multiple Sclerosis (MS). Studies have found that it not only eases muscle tightness but also improves pain, walking ability, and overall quality of life for those with MS. Other research suggests that dry needling can enhance movement and coordination, potentially helping people move more easily. Additionally, dry needling has proven effective in managing pain by increasing the level of pressure a person can tolerate, making discomfort easier to handle. Overall, these findings suggest dry needling might be a helpful, medication-free option for improving muscle issues in MS. Participants in this trial may also be assigned to a sham needling group, serving as a control to evaluate the true effectiveness of dry needling. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis who experience muscle tightness and spasms. Participants should be interested in a minimally-invasive, medication-free approach to manage these symptoms.

Inclusion Criteria

I am willing to visit the lab for a mobility test and have a stiffness level of II or III.

I am 18-64 with MS, have leg spasticity, and a PDDS score of 5 or less.

Exclusion Criteria

Inability to communicate effectively with study personnel

Presence of needle phobia

Presence of an active implanted device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dry needling treatment to improve muscle spasticity, balance, and mobility

3 weeks

3 visits (in-person, one per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling

Trial Overview

The study tests dry needling, which uses tiny needles on muscles to reduce stiffness and pain, against sham (fake) dry needling. The goal is to see if it improves spasticity, balance, and walking in Multiple Sclerosis patients.

How Is the Trial Designed?

Group I: Dry needling Experimental Treatment 1 Intervention

Participants will complete three sessions of dry needling through three weeks (one session per each week)

Group II: Sham DN Placebo Group 1 Intervention

Participants randomized to the control group will be receiving sham needling

Dry Needling is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Dry Needling for:

• Knee osteoarthritis pain management
• Muscle strength improvement
• Leg function enhancement

Approved in United States as Dry Needling for:

• Chronic knee pain relief
• Musculoskeletal pain management
• Myofascial pain syndrome treatment

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

This study aims to evaluate the immediate neurophysiological effects of dry needling (DN) on myofascial trigger points in the upper trapezius, focusing on neuromuscular junction response and sympathetic skin response.

The trial will compare outcomes in patients with trigger points to healthy participants, assessing pain intensity and pressure pain threshold before and after a single DN session, which could provide insights into the efficacy of DN as a treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neurophysiological effects of dry needling in patients with upper trapezius myofascial trigger points: study protocol of a controlled clinical trial. Abbaszadeh-Amirdehi, M., Ansari, NN., Naghdi, S., et al.[2021]

Dry needling is an effective treatment used by physical therapists to relieve pain and muscle tension, but it carries some risks, with adverse effects occurring in about 10% of cases, ranging from mild to severe.

A thorough understanding of anatomy is crucial for safely performing dry needling, as it helps minimize risks such as pneumothorax and infection, and informed consent is essential to communicate these risks to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PERTINENT DRY NEEDLING CONSIDERATIONS FOR MINIMIZING ADVERSE EFFECTS - PART ONE. Halle, JS., Halle, RJ.[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 clinical trial with 20 patients suffering from myofascial trigger points, a single session of dry needling significantly improved pain intensity, pressure pain threshold, and sympathetic skin response.

The neurophysiological response, measured by neuromuscular junction response, decreased during treatment but returned to normal afterward, indicating that dry needling effectively addresses the symptoms associated with myofascial trigger points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiological and clinical effects of dry needling in patients with upper trapezius myofascial trigger points. Abbaszadeh-Amirdehi, M., Ansari, NN., Naghdi, S., et al.[2017]

This study is the first to evaluate the effects of dry needling (DN) on multiple sclerosis patients, focusing on various outcomes like gait performance, spasticity, and quality of life, involving 40 participants over two sessions.

The results will provide insights into the efficacy of DN compared to a sham treatment, potentially guiding its clinical use for managing symptoms in individuals with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dry Needling versus Placebo on Gait Performance, Spasticity, Electromyographic Activity, Pain, Range-of-Movement and Quality of Life in Patients with Multiple Sclerosis: A Randomized Controlled Trial Protocol. Luque-Moreno, C., Granja-Domínguez, A., Moral-Munoz, JA., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8245259/

Dry needling for treating spasticity in multiple sclerosis - PMC

[Conclusion] Dry needling produces positive changes in spasticity in patients with MS and their quality of life, as well as walking capacity and ...

2.

explorationpub.com

explorationpub.com/uploads/Article/A100463/100463.pdf

Effectiveness of dry needling on the treatment of patients ...

The dry needling technique alone or in a combination of treatments was effective in improving pain, spasticity, range of motion, dexterity, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10202111/

Effects of Dry Needling on Spasticity in Multiple Sclerosis ...

The use of DN once a week has shown improvements in pain and spasms in patients with MS. In other populations such as stroke or SCI, similar ...

4.

jospt.org

jospt.org/doi/10.2519/jospt.2017.7096

The Effectiveness of Trigger Point Dry Needling for ...

Studies provided evidence that dry needling may decrease pain and increase pressure pain threshold when compared to control/sham or other treatment.

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/09645284251327198

Dry needling in multiple sclerosis: a scoping review

Only one case series in the present review reported that DN may result in immediate improvement of quality of life, disability, manual dexterity ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7015026/

ADVERSE EVENTS ASSOCIATED WITH THERAPEUTIC ...

A total of 7,531 minor AE's were reported, indicating that 36.7% of the reported TDN treatments resulted in a minor AE. The top three minor AE's were bleeding ( ...

7.

explorationpub.com

explorationpub.com/Journals/ent/Article/100463

Effectiveness of dry needling on the treatment of patients ...

In conclusion, the dry needling technique has been effective in improving MS symptoms (pain, spasticity, ROM, dexterity, mobility, limb function and quality of ...

8.

ijspt.scholasticahq.com

ijspt.scholasticahq.com/article/143187-patient-perceived-benefits-and-adverse-events-of-dry-needling

Patient-Perceived Benefits and Adverse Events of Dry Needling

Amongst all body regions, 73.8% reported improved pain; 38.5% reported improved strength; 46.2% reported improved gait; and 70.6% reported ...