NCT06145620

Brief Summary

The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress57%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

November 17, 2023

Last Update Submit

February 10, 2025

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    Disability score (0-100). Higher score indicates higher disability.

    4 weeks

Secondary Outcomes (8)

  • SF-McGill Pain Questionnaire (SF-MGPQ)

    4 weeks

  • Numerical Rating Scale (NRS)

    4 weeks

  • EuroQol-5D (EQ-5D)

    4 weeks

  • Fear avoidance beliefs questionnaire (FABQ)

    4 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Therapeutic exercise, back care and pain neuroscience education group

EXPERIMENTAL
Other: Physiotherapy

Standarized written exercise group

ACTIVE COMPARATOR
Other: Physiotherapy

Interventions

PhysiotherapyOTHER

The intervention involves the visualization of different videos explaining the performance of lumbar strengthening exercises, measures for back care, and neuroscience pain education.

Standarized written exercise groupTherapeutic exercise, back care and pain neuroscience education group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.

You may not qualify if:

  • Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.
  • Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).
  • Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).
  • Symptoms of spinal cord compression.
  • Diagnosed with a malignant tumor.
  • Mental illness.
  • Previously undergone spinal surgery.
  • No access to any internet-enabled device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arguisuelas Martinez Maria Dolores

Valencia, Spain

Location

Related Publications (3)

  • Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15.

    PMID: 29253630BACKGROUND

  • Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.

    PMID: 23478459BACKGROUND

  • Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053.

    PMID: 30921465BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

María Dolores Arguisuelas

CONTACT

96 136 90 00doloresarguisuelas@uchceu.es

María Dolores Arguisuelas

CONTACT

doloresarguisuelas@uchceu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)