NCT02664688

Brief Summary

The purpose of this study is to compare the effectiveness of pain control and functional improvement in patients with degenerative spondylolisthesis treated with "lumbar stabilization exercises" vs "flexor exercises (williams exercises)"

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

January 20, 2016

Last Update Submit

March 15, 2019

Conditions

Degenerative SpondylolisthesisChronic Low Back Pain

Keywords

spondylolisthesislow back painstabilization exercise

Outcome Measures

Primary Outcomes (2)

  • Change in Pain (VAS)

    Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."

    At baseline, 4 weeks, 3 months and 6 months

  • Change in Disability (The Roland Morris Scale)

    The Roland Morris Scale: a self-administered questionnaire consisting of 24 items. The total score can range from 0 (no disability) to 24 (maximum disability)

    At baseline, 4 weeks, 3 months and 6 months

Secondary Outcomes (1)

  • Change in use of analgesics

    At baseline, 4 weeks, 3 months and 6 months

Study Arms (2)

Lumbar stabilization exercises

EXPERIMENTAL

Home exercise program to perform daily for 6 months

Other: Lumbar stabilization exercises

Flexor Exercises

ACTIVE COMPARATOR

Home exercise program to perform daily for 6 months

Other: Flexor exercises

Interventions

Lumbar stabilization exercisesOTHER

The home-exercise program included an initial phase, with use of therapeutic heat via a hot pack for 15 minutes at the lumbosacral region, stretching exercises of the thoracolumbar fascia, hip flexors, hamstrings plus the stabilization exercises to encourage stabilizing motor patterns and determine the neutral position of the spine, with the target in control of transversus and internal oblique abdominis, multifidus, pelvic floor muscles, and diaphragmatic breathing control. Progression stages included hot packs, stretching exercises, and lateral, anterior bridges, leg raises in supine position, and arm and leg lifts in quadruped position ("bird-dog")

Lumbar stabilization exercises
Flexor exercisesOTHER

The home-exercise program included a hot pack for 15 minutes and flexor exercises routine

Also known as: Williams exercises
Flexor Exercises

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Degenerative spondylolisthesis at L4-L5 and chronic LBP with or without radicular pain
  • Attending the Spinal Rehabilitation Service of the National Institute for Rehabilitation (Mexico City).
  • Without previous treatment
  • Agree to participate through informed consent.

You may not qualify if:

  • History of lumbar surgery,
  • Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc.
  • Cauda equine symptoms,
  • Ischemic heart disease
  • Diabetic polyneuropathy
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INRMexico

Mexico City, 14389, Mexico

Location

Related Publications (3)

  • Nava-Bringas TI, Hernandez-Lopez M, Ramirez-Mora I, Coronado-Zarco R, Israel Macias-Hernandez S, Cruz-Medina E, Arellano-Hernandez A, Leon-Hernandez SR. Effects of a stabilization exercise program in functionality and pain in patients with degenerative spondylolisthesis. J Back Musculoskelet Rehabil. 2014;27(1):41-6. doi: 10.3233/BMR-130417.

    PMID: 23948848RESULT

  • Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.

    PMID: 25238480RESULT

  • Nava-Bringas TI, Romero-Fierro LO, Trani-Chagoya YP, Macias-Hernandez SI, Garcia-Guerrero E, Hernandez-Lopez M, Roberto CZ. Stabilization Exercises Versus Flexion Exercises in Degenerative Spondylolisthesis: A Randomized Controlled Trial. Phys Ther. 2021 Aug 1;101(8):pzab108. doi: 10.1093/ptj/pzab108.

    PMID: 33792726DERIVED

MeSH Terms

Conditions

SpondylolisthesisLow Back Pain

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • TANIA I NAVA-BRINGAS, MSc

    Instituto Nacional de Rehabilitacion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc; MD

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 27, 2016

Study Start

July 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 19, 2019

Record last verified: 2018-03

Locations

ME(1)