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NCT Number: NCT07615725

Dry Needling in Multiple Sclerosis

This study is placed at the Human Functional Performance Laboratory in the School of physical therapy and Rehabilitation Sciences (MDT building) at University of South Florida. The study is supported by Consortium of Multiple Sclerosis Centers. We are doing this study to see if a treatment called dry needling improves chronic pain in the lower limb (from the low back to the foot) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those used in acupuncture, to target certain muscles, such as the thigh or calf muscles. It is different from traditional acupuncture because it focuses on treating specific muscle spots to reduce muscle stiffness and pain. Dry needling may help reduce your pain without any medication. We also hope to see whether dry needling helps improve balance and walking abilities, which may lead to better day-to-day functioning. In this study, there are two groups. In each group, participants will receive six sessions of dry needling. One group will receive actual dry needling, while the other group will receive a procedure that mimics dry needling. The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given either treatment or sham treatment. You will not be told which treatment you are getting; however your study doctor will know. You are being asked to take part because you have been diagnosed with Multiple Sclerosis and are experiencing long-lasting pain in your lower limbs, including the buttocks, thighs, calf, and foot. We want to find out if this treatment will help people with Multiple Sclerosis who have lower limb pain.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Amir Tabatabaei, PhD

CONTACT

[email protected]

913-212-6375

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of Multiple Sclerosis based on McDonald's Criteria; Patient Determined Disease Steps (PDDS) score of 1-5 (ambulatory participants), the ability to communicate written and spoken English, , age 18-80 and experiencing pain in the lower extremity for more than three consecutive months (3-months) with intensity of 3 or more out of 10 based on numeric pain scale (clinically meaningful pain).

Exclusion criteria

any neurological comorbidity (such as stroke and PD), presence of MS relapse in the last 30 days, current participation in or planned initiation of any pain management intervention (interventional or rehabilitative) targeting the lower extremity, or anticipated changes in pain medication during the study period. Additional exclusion criteria include pregnancy (by urine pregnancy test), any active cancer or chemotherapy within one year, the score of lower than 17 on the MoCA (Montreal Cognitive Assessment), a known or suspected infection in the lower extremity, deep vein thrombosis, thrombophlebitis, active osteomyelitis in the lower extremity, varicose veins and uncontrolled seizures/ epilepsy.

Treatment and study plan

dry needling

Procedure

Participants will receive dry needling treatment targeting lower-extremity muscles associated with chronic pain in people with multiple sclerosis. The intervention will be delivered over six treatment sessions by a licensed physical therapist trained in dry needling techniques.

Sham Dry needling

Procedure

Participants assigned to the sham dry needling group will receive a control procedure designed to mimic the experience of dry needling without therapeutic needle insertion into the target muscle tissue. The procedure will be delivered over six sessions by a licensed physical therapist trained in dry needling and sham procedures.

Primary outcomes

  1. Pain PROMIS

    Time frame: Baseline, after completion of dry needling sessions, and 2-month follow-up; changes will be compared with baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Tabatabaei, PhD

CONTACT

[email protected]

8139747193

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Non-pharmacological Management of Chronic Pain in Persons With Multiple Sclerosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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