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Dry Needling in Multiple Sclerosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether dry needling can help long-lasting pain from the low back to the foot in people with multiple sclerosis (MS). Dry needling uses tiny needles in specific muscle spots. The study compares six sessions of real or pretend dry needling and also checks balance and walking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have MS diagnosed using a set of rules called the McDonald criteria.
  • You are 18 to 80 years old.
  • You can walk and have a Patient Determined Disease Steps (PDDS) score of 1 to 5.
  • You can communicate in written and spoken English.
  • You have had lower limb pain for more than 3 months in a row.
  • Your pain is rated at least 3 out of 10.

Who can't join

  • You have another brain or nerve condition, such as stroke or Parkinson’s disease, or seizures that are not controlled.
  • You have had an MS flare-up in the past 30 days.
  • You are getting or plan to start a procedure or rehab for lower limb pain, or expect changes in pain medicine during the study.
  • You are pregnant, based on a urine test.
  • You have active cancer or have had chemotherapy within the past year.
  • You score below 17 on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.
  • You have a known or suspected lower limb infection, including an active bone infection.
  • You have a blood clot in a deep vein, an inflamed vein with a clot, or varicose veins (swollen, twisted veins).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL