NCT07615725

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
May 2026Jun 2027

Study Start

First participant enrolled

May 8, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 22, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain PROMIS

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

Study Arms (2)

Intervention

EXPERIMENTAL
Procedure: Dry Needling

Control

SHAM COMPARATOR
Procedure: Sham Dry Needling

Interventions

Dry NeedlingPROCEDURE

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.

Intervention

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.

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisPain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Amir Tabatabaei, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 8, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

Locations