Dry Needling for Multiple Sclerosis

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.

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.

How is the treatment Dry Needling unique for Multiple Sclerosis?

Dry Needling is unique for Multiple Sclerosis as it targets muscular trigger points to reduce pain and muscle tension, potentially improving gait and quality of life. Unlike other treatments, it involves inserting thin needles into specific muscles to release tension and improve muscle function, which is a novel approach for this condition. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

PERTINENT DRY NEEDLING CONSIDERATIONS FOR MINIMIZING ADVERSE EFFECTS - PART ONE. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Inhibitory effect of dry needling on the spontaneous electrical activity recorded from myofascial trigger spots of rabbit skeletal muscle. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Neurophysiological and clinical effects of dry needling in patients with upper trapezius myofascial trigger points. [2017]

5. England 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. [2021]