Recruiting

Dry Needling

Sponsor:

University of South Florida

Code:

NCT07615725

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dry Needling

Sham Dry Needling

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Study ID

NCT07615725

Start date

May 8, 2026

Status verified date

May, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

sham comparator: Control

Interventions

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.

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 measure

  • Pain PROMIS [ Time Frame: Baseline, after completion of dry needling sessions, and 2-month follow-up; changes will be compared with baseline. ]

Central Contacts and Locations

Central contacts

Amir Tabatabaei, PhD

8139747193tabatabaei@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

More Information

Sponsor

University of South Florida

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-05-29.