Neck PainNCT05860751
The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
A study testing Dry Needling with electrical stimulation in people with Neck Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry Needling with electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Clinical diagnosis of restless legs syndrome
Who cannot join
- Active cancer diagnoses
- Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
- Pregnancy
- Immunocompromised disease (e.g., HIV, AIDS, lupus)
- Insufficient English-language skills to complete all questionnaires
- Inability to maintain treatment positions
Show all 10Show fewer
- Contraindications to dry needling:35,36
- Presence of needle phobia
- History of abnormal reaction to needling or injection
- History of bleeding disorder
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
Mayo Clinic
Rochester, Minnesota, 55905
Ray Lunasin, 507-538-0839, lunasin.ray@mayo.edu
About this study
The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.
- Conditions
- Neck Pain
- Being tested
- Dry Needling with electrical stimulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling with electrical stimulationProcedure or surgery
Administered for a total of 2 sessions at a frequency of once per week. The target muscles to be needled will include the gastronemius, soleus, vastus lateralis, rectus femoris, anterior tibialis, posterior tibialis, biceps femoris, and gluteus medius.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling with electrical stimulation | Experimental | Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities Receives: Procedure: Dry Needling with electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire that measures general sleep quality. The scoring range is 0-21 with 0-3 scoring for each component. Higher scores indicate worse sleep quality.
Measured: Baseline, 4 weeks and 8 weeks post-intervention
Change in periodic limb movement
Measured using a consumer-grade sleep tracking device.
Measured: Baseline, weekly for 3 weeks
Change in Restless Legs Syndrome symptom severity
RLS symptom severity of each participant will be indexed with likert scale ratings and subacutely by completion of the International Restless Legs Syndrome Rating Scale (IRLSRS). The IRLSRS has demonstrated to be a valid and reliable outcome measure for RLS symptom severity. The scale consists of 10 questions concerning each patient's symptoms and the impact of those symptoms on daily activities and mood. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40 with higher scores indicating more severe symptoms.
Measured: Baseline, 4 weeks and 8 weeks post-intervention
Secondary outcomes (3)
Change in pain level
Measured using the Numerical Pain Rating Scale (NPRS), an 11-point numeric scale ranging from '0' representing "no pain" to '10' representing "worst pain imaginable."
Measured: Baseline, 4 weeks and 8 weeks post-intervention
Change in quality of life
Quality of life will be measured using the EuroQol (EQ-5D-5L), a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on a scale that describes the degree of problems in that area. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. The EuroQol has been identified as a valid and reliable outcome measurement for quality of life.
Measured: Baseline, 4 weeks and 8 weeks post-intervention
Acute change in Restless Legs Syndrome symptoms
Likert Scale
Measured: Baseline, Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startFeb 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray M. Lunasin, Mayo Clinic
- Investigators
- Ray Lunasin, PT, DPT, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860751
- Sponsor's protocol ID
- 22-009645
- Status last verified
- Mar 2026
- First submitted
- 8 May 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT05860751
- Acronym / sponsor ID
- 22-009645
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 May 2023 (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.
The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry needling with electrical stimulation | Experimental | Procedure: Dry Needling with electrical stimulationParticipants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years
- Clinical diagnosis of restless legs syndrome
Key exclusion criteria (10 listed)
- Active cancer diagnoses
- Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
- Pregnancy
- Immunocompromised disease (e.g., HIV, AIDS, lupus)
- Insufficient English-language skills to complete all questionnaires
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 Needling with electrical stimulationAdministered for a total of 2 sessions at a frequency of once per week. The target muscles to be needled will include the gastronemius, soleus, vastus lateralis, rectus femoris, anterior tibialis, posterior tibialis, biceps femoris, and gluteus medius. | Procedure or surgery | Dry needling with electrical stimulation |
Primary outcome
Change in sleep quality
Time frame: Baseline, 4 weeks and 8 weeks post-intervention
Measured using the Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire that measures general sleep quality. The scoring range is 0-21 with 0-3 scoring for each component. Higher scores indicate worse sleep quality.
Change in periodic limb movement
Time frame: Baseline, weekly for 3 weeks
Measured using a consumer-grade sleep tracking device.
Change in Restless Legs Syndrome symptom severity
Time frame: Baseline, 4 weeks and 8 weeks post-intervention
RLS symptom severity of each participant will be indexed with likert scale ratings and subacutely by completion of the International Restless Legs Syndrome Rating Scale (IRLSRS). The IRLSRS has demonstrated to be a valid and reliable outcome measure for RLS symptom severity. The scale consists of 10 questions concerning each patient's symptoms and the impact of those symptoms on daily activities and mood. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40 with higher scores indicating more severe symptoms.
3 secondary outcomes
Change in pain level
Time frame: Baseline, 4 weeks and 8 weeks post-intervention
Change in quality of life
Time frame: Baseline, 4 weeks and 8 weeks post-intervention
Acute change in Restless Legs Syndrome symptoms
Time frame: Baseline, Immediately post-intervention
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 16 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ray Lunasin, PT, DPT, PhD principal investigator
Mayo Clinic
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 with electrical stimulation in people with Neck Pain, run by Mayo Clinic 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Mar 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. 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 Ray Lunasin, PT, DPT, PhD (5075380839, lunasin.ray@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality (time frame: Baseline, 4 weeks and 8 weeks post-intervention). The study lists 3 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 16 Mar 2026.