Degenerative Lumbar Stenosis Conservative Treatment

NCT ID: NCT04492774

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-12-31

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.

Conditions

Spinal Stenosis Lumbar; Spinal Canal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GOLDIC serum

Epidural ultrasound guided injections

Group Type: EXPERIMENTAL

Goldic serum

Intervention Type: COMBINATION_PRODUCT

epidural injections

Steroid

Epidural ultrasound guided injections

Group Type: ACTIVE_COMPARATOR

Steroid injections

Intervention Type: DRUG

epidural injections

Manual therapy

veno-lymphatic spinal drainage

Group Type: ACTIVE_COMPARATOR

Manual therapy

Intervention Type: PROCEDURE

Veno-lymphatic drainage

Interventions

Goldic serum

epidural injections

Intervention Type: COMBINATION_PRODUCT

Steroid injections

epidural injections

Intervention Type: DRUG

Manual therapy

Veno-lymphatic drainage

Intervention Type: PROCEDURE

Other Intervention Names

Autologous serum; Dexamethasone; drainage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sutherland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Piotr Godek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piotr Godek, PhD

Role: PRINCIPAL_INVESTIGATOR

Sutherland Medical Center

Locations

Sutherland Medical Center

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 35899459 (View on PubMed)

Other Identifiers

SMC2020002

Identifier Type: -

Identifier Source: org_study_id