Degenerative Lumbar Stenosis Conservative Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for patients over 65 years of age. It is assumed that in the United States alone, it affects about 200 thousand patients causing significant impairment of their quality of life. Although it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion, facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of DLSS management, especially in the group of older patients, is still the matter of debate. Three main concepts of conservative treatment are considered: 1) pharmacological care - symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections, 2) rehabilitations protocols and mechanical devices like traction facilities or corsets to decompress spinal canal or support in case of instability, 3) biological - stimulation of anti-inflammatory action and regeneration capacity by biologically active substances. All methods are offered without strong evidence of its efficacy. AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections, manual therapy in the concept of spinal canal venous drainage. Research hypothesis: The use of Goldic serum in epidural injections improves the condition of patients with DLSS during the observation period longer than steroid injections and the rehabilitation protocol. DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients, single-centre study. POPULATION: the local adult population METHODS: Three groups of patients (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions according to the inclusion and exclusion criteria. There will be 30 people in each group (90 people in total). Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of serum (4 doses of 3 ml in total), injections performed into the epidural space under ultrasound control by the same operator. Group B - steroid therapy with Dexaven 4 mg / 1 ml - 2 injections at weekly intervals containing single doses of dexamethasone (total dose of 8 mg), injections will be performed into the epidural space under ultrasound control by the same operator. Group C - manual therapy according to the concept of venous drainage - a repeatable treatment scheme for each patient; decompression of the thoracic outlet, diaphragm release, sacroiliac joints (SI) mobilizations, rib-sternum release, rib raising technique - 4 sessions (1 x weekly - approx. 40 min). Control tools: NRS Pain Scale (0-10), Oswestry Disability Index, Zurich Claudication Questionnaire (ZCQ), EQ-5D-5L, Control points: Initial Assessment (IA), 4,12, 24 weeks after last intervention.

Official Title
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GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial

Conditions
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Spinal Stenosis Lumbar, Spinal Canal Stenosis

Intervention / Treatment
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* Combination Product: Goldic serum
* Drug: Steroid injections
* Procedure: Manual therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOLDIC serum<br>Epidural ultrasound guided injections | Combination Product: Goldic serum<br>* epidural injections<br>* Other names: Autologous serum;|
| Active Comparator: Steroid<br>Epidural ultrasound guided injections | Drug: Steroid injections<br>* epidural injections<br>* Other names: Dexamethasone;|
| Active Comparator: Manual therapy<br>veno-lymphatic spinal drainage | Procedure: Manual therapy<br>* Veno-lymphatic drainage<br>* Other names: drainage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D-5L index from baseline to 24 weeks | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 24 weeks | 
| Change in Oswestry Disability Index from baseline to 24 weeks | Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score). | Change from baseline to 24 weeks | 
| Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks | Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score). | Change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity according to Numeric Rating Scale | Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain). | Change from baseline to 4 weeks | 
| Change in pain intensity according to Numeric Rating Scale | Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain). | Change from baseline to 12 weeks | 
| Change in pain intensity according to Numeric Rating Scale | Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain). | Change from baseline to 24 weeks | 
| Change in EQ-5D-5L index from baseline to 4 weeks | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 4 weeks | 
| Change in EQ-5D-5L index from baseline to 12 weeks | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 12 weeks | 
| Change in Oswestry Disability Index from baseline to 4 weeks | Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score). | Change from baseline to 4 weeks | 
| Change in Oswestry Disability Index from baseline to 12 weeks | Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score). | Change from baseline to 12 weeks | 
| Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks | Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score). | Change from baseline to 4 weeks | 
| Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks | Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score). | Change from baseline to 12 weeks |