RecruitingNot a drug-phase studyMS (type not specified)NCT07615725

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Dry Needling

Placebo or sham

  • Sham Dry Needling

What it measured

Main measures

  • Percentage of Planned Dry Needling Treatment Sessions Completed

    immediately after the intervention

    Quality of life (reported by participants)Feasibility
  • Percentage of Dry Needling Sites With an Elicited Local Twitch Response

    immediately after the intervention

  • Treatment Credibility Score on the Credibility/Expectancy Questionnaire

    immediately after the intervention

  • Number of Serious Adverse Events During Study Participation

    immediately after the intervention

    SafetyFeasibility

Other measures (5)

  • The Patient-Reported Outcomes Measurement Information System Pain Intensity

    Baseline, 3 weeks (post-treatment), and 1 month after treatment completion

    PainQuality of life (reported by participants)
  • Change in Pressure Pain Threshold Measured Using a Pressure Algometer

    Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.

    Pain
  • Change in Walking Performance Measured by the Timed 25-Foot Walk Test

    Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.

    Disability progressionWalking and mobility
  • Change in Functional Mobility Measured by the Timed Up and Go Test

    Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.

    Walking and mobility
  • Change in Postural Sway Measured by an Accelerometer During Static Standing

    Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 80

**Inclusion Criteria:** * Diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria * Patient Determined Disease Steps (PDDS) score of 1-5 (ambulatory participants) * Ability to communicate in written and spoken English * Age 18-80 years * Chronic lower-extremity pain lasting more than three consecutive months, with a pain intensity of at least 3 out of 10 on the Numeric Pain Rating Scale (NPRS) **Exclusion Criteria:** * Any neurological comorbidity (e.g., stroke or Parkinson's disease) * MS relapse within the past 30 days * Current participation in or planned initiation of any pain management intervention (interventional or rehabilitative) targeting the lower extremity * Anticipated changes in pain medication during the study period * Pregnancy, as determined by a urine pregnancy test * Active cancer or chemotherapy within the past year * Montreal Cognitive Assessment (MoCA) score below 17 * Known or suspected infection in the lower extremity * Deep vein thrombosis * Thrombophlebitis * Active osteomyelitis in the lower extremity * Varicose veins * Uncontrolled seizures or epilepsy

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This study is being conducted at the Human Functional Performance Laboratory in the School of Physical Therapy and Rehabilitation Sciences (MDT Building) at the University of South Florida. The study is supported by the Consortium of Multiple Sclerosis Centers. The investigators are conducting this study to determine whether a treatment called dry needling can improve chronic pain in the lower body (from the low back to the foot) in people with Multiple Sclerosis. Dry needling involves inserting tiny needles, similar to those used in acupuncture, into specific muscles, such as the thigh or calf muscles. Unlike traditional acupuncture, dry needling targets specific muscle areas to reduce muscle stiffness and pain. Dry needling may help reduce pain without medication. The investigators also aim to determine whether dry needling can improve balance and walking abilities, potentially leading to better day-to-day functioning. Participants will be assigned to one of two groups. Both groups will receive six treatment sessions. One group will receive actual dry needling, while the other group will receive a sham procedure designed to mimic dry needling. Treatment assignment will be determined randomly, similar to flipping a coin. Neither participants nor the study doctor will choose the assigned treatment. Each participant will have an equal chance of receiving actual dry needling or the sham procedure. Participants will not be informed of the assigned treatment; however, the study doctor will know the treatment assignment. Participants are being invited to take part in this study because of a diagnosis of Multiple Sclerosis and the presence of chronic pain in the lower body, including the buttocks, thighs, calves, or feet. The investigators aim to determine whether dry needling can help reduce chronic lower-body pain in people with Multiple Sclerosis.

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History

    1. Started

      May 2026

    2. Main results due

      May 2027

    3. Finished

      Jun 2027

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