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 range18 Years

SexALL

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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
✕. Lack of consent to participate in the study

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