Multiple SclerosisNCT07615725
Dry Needling in Multiple Sclerosis
A study testing Dry Needling in people with Multiple Sclerosis, run by University of South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Amir Tabatabaei, PhD, 913-212-6375, tabatabaei@usf.edu
About this study
Official title: Non-pharmacological Management of Chronic Pain in Persons With Multiple Sclerosis
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Dry Needling, Sham Dry Needling
- Keywords
- Pain
- Medical subject headings
- Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
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 NeedlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: Dry Needling |
| Control | Sham comparator | Not described Receives: Procedure: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Planned Dry Needling Treatment Sessions Completed
Treatment adherence will be calculated as the number of completed treatment sessions divided by the total number of planned sessions, multiplied by 100. Each participant is scheduled to receive six treatment sessions. Adherence will range from 0% to 100%, with higher percentages indicating better adherence. The feasibility target is completion of at least 80% of planned sessions.
Measured: immediately after the intervention
Percentage of Dry Needling Sites With an Elicited Local Twitch Response
Practicality will be measured as the percentage of treated muscle sites at which a local twitch response (LTR) is elicited during actual dry needling. An LTR is a brief, involuntary muscle contraction that may occur when a needle stimulates a sensitive area within a muscle. The percentage will be calculated as the number of needling sites with an observed LTR divided by the total number of needling sites assessed, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating more frequent elicitation of an LTR.
Measured: immediately after the intervention
Treatment Credibility Score on the Credibility/Expectancy Questionnaire
Treatment credibility will be assessed using the credibility subscale of the Credibility/Expectancy Questionnaire (CEQ), which measures how logical and believable participants consider the treatment. The subscale consists of three items scored from 1 to 9, producing a total score ranging from 3 to 27. Higher scores indicate greater treatment credibility and a more favorable outcome.
Measured: immediately after the intervention
Number of Serious Adverse Events During Study Participation
Safety will be assessed by recording the number of serious adverse events occurring during study participation. Serious adverse events include events resulting in death, life-threatening conditions, hospitalization, persistent or significant disability, or other medically important conditions. The total number of serious adverse events will be reported for each treatment group. Fewer serious adverse events indicate a more favorable safety outcome. The feasibility hypothesis is that no serious adverse events will occur.
Measured: immediately after the intervention
Secondary outcomes (5)
The Patient-Reported Outcomes Measurement Information System Pain Intensity
Change in Pain Intensity Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a (Raw Score: 3-15; Higher Scores Indicate Worse Outcomes)
Measured: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion
Change in Pressure Pain Threshold Measured Using a Pressure Algometer
Pressure pain threshold (PPT) will be assessed using a pressure algometer to measure mechanical pain sensitivity. Pressure will be gradually applied to selected muscle sites until participants first report that the pressure becomes painful. Higher PPT values indicate lower pain sensitivity and better outcomes. Changes from baseline will be compared between the actual and sham dry needling groups.
Measured: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Walking Performance Measured by the Timed 25-Foot Walk Test
Walking performance will be assessed using the Timed 25-Foot Walk (T25FW) test. Participants will be instructed to walk a distance of 25 feet as quickly and safely as possible. The time required to complete the test will be recorded in seconds. Lower completion times indicate faster walking speed and better mobility. Changes from baseline will be compared between the actual and sham dry needling groups.
Measured: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Functional Mobility Measured by the Timed Up and Go Test
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants will stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time required to complete the test will be recorded in seconds. Lower completion times indicate better functional mobility. Changes from baseline will be compared between the actual and sham dry needling groups.
Measured: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Postural Sway Measured by an Accelerometer During Static Standing
Static standing balance will be assessed using a body-worn accelerometer to measure postural sway during quiet standing. Postural sway refers to the movement of the body while maintaining a standing position. Greater sway magnitude indicates poorer balance, while lower values indicate better postural stability. Changes from baseline will be compared between the actual and sham dry needling groups.
Measured: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start8 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615725
- Sponsor's protocol ID
- STUDY009741
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacological Management of Chronic Pain in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07615725
- Acronym / sponsor ID
- STUDY009741
- Conditions
- Multiple Sclerosis
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Dry Needling |
| Control | Sham comparator | Procedure: Sham Dry Needling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingParticipants 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 or surgery | Intervention |
| Sham Dry NeedlingParticipants 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. | Procedure or surgery | Control |
Primary outcome
Percentage of Planned Dry Needling Treatment Sessions Completed
Time frame: immediately after the intervention
Treatment adherence will be calculated as the number of completed treatment sessions divided by the total number of planned sessions, multiplied by 100. Each participant is scheduled to receive six treatment sessions. Adherence will range from 0% to 100%, with higher percentages indicating better adherence. The feasibility target is completion of at least 80% of planned sessions.
Percentage of Dry Needling Sites With an Elicited Local Twitch Response
Time frame: immediately after the intervention
Practicality will be measured as the percentage of treated muscle sites at which a local twitch response (LTR) is elicited during actual dry needling. An LTR is a brief, involuntary muscle contraction that may occur when a needle stimulates a sensitive area within a muscle. The percentage will be calculated as the number of needling sites with an observed LTR divided by the total number of needling sites assessed, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating more frequent elicitation of an LTR.
Treatment Credibility Score on the Credibility/Expectancy Questionnaire
Time frame: immediately after the intervention
Treatment credibility will be assessed using the credibility subscale of the Credibility/Expectancy Questionnaire (CEQ), which measures how logical and believable participants consider the treatment. The subscale consists of three items scored from 1 to 9, producing a total score ranging from 3 to 27. Higher scores indicate greater treatment credibility and a more favorable outcome.
Number of Serious Adverse Events During Study Participation
Time frame: immediately after the intervention
Safety will be assessed by recording the number of serious adverse events occurring during study participation. Serious adverse events include events resulting in death, life-threatening conditions, hospitalization, persistent or significant disability, or other medically important conditions. The total number of serious adverse events will be reported for each treatment group. Fewer serious adverse events indicate a more favorable safety outcome. The feasibility hypothesis is that no serious adverse events will occur.
5 secondary outcomes
The Patient-Reported Outcomes Measurement Information System Pain Intensity
Time frame: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion
Change in Pressure Pain Threshold Measured Using a Pressure Algometer
Time frame: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Walking Performance Measured by the Timed 25-Foot Walk Test
Time frame: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Functional Mobility Measured by the Timed Up and Go Test
Time frame: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Change in Postural Sway Measured by an Accelerometer During Static Standing
Time frame: Baseline, 3 weeks (post-treatment), and 1 month after treatment completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Multiple Sclerosis, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir Tabatabaei, PhD (8139747193, tabatabaei@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Planned Dry Needling Treatment Sessions Completed (time frame: immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.