NCT07615725 · University of South Florida
Dry Needling in Multiple Sclerosis
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Dry Needling
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.
PROCEDURE
Sham Dry Needling
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 outcome measures
Pain PROMIS
Time frame: Baseline, after completion of dry needling sessions, and 2-month follow-up; changes will be compared with baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tampa, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations