UnknownPhase 4

Degenerative Lumbar Stenosis Conservative Treatment

Poland90 participantsStarted 2020-07-01

Plain-language summary

The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Clinical signs of lumbar spinal stenosis
. Radiological signs of lumbar spinal stenosis confirmed by MRI
. No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
. Mental state allowing cooperation during manual therapy
. An adult who consents to participate in the study
. No previous surgery or spinal epidural injections

Exclusion criteria

. The presence of serious neurological deficits
. Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
. Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
. Previous surgery or spinal epidural injections of lumbar spine
. Mental state preventing cooperation during manual therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in EQ-5D-5L index from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks

Change in Oswestry Disability Index from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks

Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks

Trial details

NCT IDNCT04492774

SponsorSutherland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Spinal Stenosis Lumbar trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Clinical signs of lumbar spinal stenosis
. Radiological signs of lumbar spinal stenosis confirmed by MRI
. No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
. Mental state allowing cooperation during manual therapy
. An adult who consents to participate in the study
. No previous surgery or spinal epidural injections

Exclusion criteria

. The presence of serious neurological deficits
. Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
. Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
. Previous surgery or spinal epidural injections of lumbar spine
. Mental state preventing cooperation during manual therapy

What they're measuring

Change in EQ-5D-5L index from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks

Change in Oswestry Disability Index from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks

Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks

Timeframe: Change from baseline to 24 weeks