Degenerative Lumbar Stenosis Conservative Treatment

Phase 4

• Conditions: Spinal Canal Stenosis; Spinal Stenosis Lumbar
• Interventions: Combination Product: Goldic serum; Drug: Steroid injections; Procedure: Manual therapy

• Registration Number: NCT04492774
• Lead Sponsor: Sutherland Medical Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

1. The presence of serious neurological deficits
2. Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
3. Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
4. Previous surgery or spinal epidural injections of lumbar spine
5. Mental state preventing cooperation during manual therapy
6. Lack of consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GOLDIC serum	Goldic serum	Epidural ultrasound guided injections
Steroid	Steroid injections	Epidural ultrasound guided injections
Manual therapy	Manual therapy	veno-lymphatic spinal drainage

Primary Outcome Measures

Name	Time	Method
Change in EQ-5D-5L index from baseline to 24 weeks	Change 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 in Oswestry Disability Index from baseline to 24 weeks	Change from baseline to 24 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks	Change from baseline to 24 weeks	Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).

Secondary Outcome Measures

Name	Time	Method
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks	Change from baseline to 4 weeks	Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks	Change from baseline to 12 weeks	Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
Change in pain intensity according to Numeric Rating Scale	Change from baseline to 24 weeks	Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
Change in EQ-5D-5L index from baseline to 4 weeks	Change 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 in EQ-5D-5L index from baseline to 12 weeks	Change 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 in Oswestry Disability Index from baseline to 4 weeks	Change from baseline to 4 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Change in Oswestry Disability Index from baseline to 12 weeks	Change from baseline to 12 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).

Trial Locations

Locations (1)

Sutherland Medical Center; 🇵🇱 Warszawa, Mazovia, Poland