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Spine injection may quiet restless legs, small study hints

NCT ID NCT07637643

Symptom relief Sponsor: Saglik Bilimleri Universitesi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a lumbar epidural steroid injection can reduce restless legs syndrome symptoms in 45 adults with lumbar central spinal stenosis. Participants received a standard injection as part of routine care, and their restless legs severity, pain, disability, and sleep quality were measured before treatment and at 3 weeks and 3 months after. The goal is to see if this common pain treatment also helps with restless legs and related sleep problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epidural steroid injection (dexamethasone, lidocaine, normal saline)
What this could lead to
If successful, this injection could provide a new way to reduce restless legs symptoms and improve sleep in people with lumbar spinal stenosis.
What could go wrong
This is a small, observational study with no control group, so results may not be definitive. The injection carries typical risks like infection or nerve irritation, and benefits may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

45 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients aged 18 to 75 years with moderate-to-severe lumbar central spinal stenosis confirmed by magnetic resonance imaging (MRI), chronic low back and leg pain refractory to conservative treatment, and symptoms consistent with restless legs syndrome who are scheduled to undergo fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age between 18 and 75 years Ability to understand the study procedures and provide written informed consent Moderate or severe lumbar central spinal stenosis confirmed by magnetic resonance imaging (MRI) Chronic low back and leg pain attributed to lumbar central spinal stenosis Symptoms of restless legs syndrome Pain intensity ≥4 on the Numeric Rating Scale (NRS) Symptom duration ≥3 months Persistent symptoms despite conservative treatment and maximum tolerated medical therapy Planned fluoroscopy-guided lumbar interlaminar epidural steroid injection as part of routine clinical care - Exclusion Criteria: Radicular pain limited to a single nerve root distribution Vascular claudication History of peripheral vascular disease Previous lumbosacral spine surgery Polyneuropathy or lower extremity entrapment neuropathy Local or systemic infection Rheumatologic disease Neurodegenerative disease Diabetes mellitus Moderate to severe chronic kidney disease Ankylosing spondylitis or rheumatoid arthritis Epidural steroid injection within the previous 6 months Foraminal stenosis causing dynamic or postural radiculopathy Current use of antidepressant, sedative, or hypnotic medications Iron deficiency anemia Vitamin B12 deficiency Known history of restless legs syndrome or family history of restless legs syndrome Failure to receive maximum tolerated medical therapy \-

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Conditions

The condition(s) this trial relates to.

lumbar spinal stenosis restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbar central spinal stenosis Restless legs syndrome

Contacts and locations

Locations

  • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

    Ankara, Turkey (Türkiye)

  • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010, Ankara,

    Ankara, Turkey (Türkiye)

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