NCT04492774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

July 20, 2020

Last Update Submit

March 10, 2021

Conditions

Spinal Stenosis LumbarSpinal Canal Stenosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Change in pain intensity according to Numeric Rating Scale

    Change from baseline to 4 weeks

  • Change in pain intensity according to Numeric Rating Scale

    Change from baseline to 12 weeks

  • Change in pain intensity according to Numeric Rating Scale

    Change from baseline to 24 weeks

  • Change in EQ-5D-5L index from baseline to 4 weeks

    Change from baseline to 4 weeks

  • Change in EQ-5D-5L index from baseline to 12 weeks

    Change from baseline to 12 weeks

  • +4 more secondary outcomes

Study Arms (3)

GOLDIC serum

EXPERIMENTAL

Epidural ultrasound guided injections

Combination Product: Goldic serum

Steroid

ACTIVE COMPARATOR

Epidural ultrasound guided injections

Drug: Steroid injections

Manual therapy

ACTIVE COMPARATOR

veno-lymphatic spinal drainage

Procedure: Manual therapy

Interventions

Goldic serumCOMBINATION_PRODUCT

epidural injections

Also known as: Autologous serum
GOLDIC serum
Steroid injectionsDRUG

epidural injections

Also known as: Dexamethasone
Steroid
Manual therapyPROCEDURE

Veno-lymphatic drainage

Also known as: drainage
Manual therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutherland Medical Center

Warsaw, Masovian Voivodeship, 04-036, Poland

Location

Related Publications (1)

  • 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.

    PMID: 35899459DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

DexamethasoneMusculoskeletal ManipulationsDrainage

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationSurgical Procedures, Operative

Study Officials

  • Piotr Godek, PhD

    Sutherland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open label)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 30, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)