Degenerative Lumbar Stenosis Conservative Treatment (GOLDSTEN)

GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Stenosis Lumbar; Spinal Canal Stenosis
• Intervention / Treatment: Combination product: Goldic serum; Drug: Steroid injections; Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Mazovia
    • Warszawa, Mazovia, Poland, 04-036
      • Sutherland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOLDIC serum; Epidural ultrasound guided injections	Combination product: Goldic serum; epidural injections; Other Names: Autologous serum
Active Comparator: Steroid; Epidural ultrasound guided injections	Drug: Steroid injections; epidural injections; Other Names: Dexamethasone
Active Comparator: Manual therapy; veno-lymphatic spinal drainage	Procedure: Manual therapy; Veno-lymphatic drainage; Other Names: drainage

What is the study measuring?

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 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 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 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

Collaborators and Investigators

• Sponsor: Sutherland Medical Center
• Investigators: Principal Investigator: Piotr Godek, PhD, Sutherland Medical Center

Publications and helpful links

General Publications

• Godek P, Szczepanowska-Wolowiec B, Golicki D. GOLDIC therapy in degenerative lumbar spinal stenosis: randomized, controlled trial. Regen Med. 2022 Oct;17(10):709-718. doi: 10.2217/rme-2022-0047. Epub 2022 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: SMC2020002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No