Clinical trial NCT02664688: Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis
Official title: Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spondylolisthesis
Chronic Low Back Pain
Keywords: spondylolisthesis
low back pain
stabilization exercise
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
First posted: 2016-01-27
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)"

Detailed description: This study is a randomized controlled trial in patients with the diagnosis of degenerative spondylolisthesis.

To date, it is known that lumbar stabilization exercises are an effective treatment option in controlling pain and improving function in patients with degenerative spondylolisthesis based on previous studies, but it is not known if is this a better treatment that another exercises routine for chronic LBP (Low Back Pain).

The purpose is to compare the effectiveness on pain control and functional improvement of "lumbar stabilization exercises" vs "flexor exercises (williams exercises)".

All clinical evaluations are performed by a single physician who is blinded to the exercises, and include a full medical history, physical examination, and x-ray measurement.

After initial evaluation, patients are given a sealed envelope containing the treatment (by simple randomization assigned by the investigator). The envelope is opened by the physical therapist which schedules a monthly session and verify the correct execution of each exercise. Each patient receives a sheet with instructions of the exercises to continue daily at home.

Scales to assess pain and function will be recorded at baseline, 4 weeks, 3 months and at 6 months to complete the follow up.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Pain (VAS)
timeFrame: At baseline, 4 weeks, 3 months and 6 months
measure: Change in Disability (The Roland Morris Scale)
timeFrame: At baseline, 4 weeks, 3 months and 6 months
Secondary outcomes:
measure: Change in use of analgesics
timeFrame: At baseline, 4 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: INRMexico
Study officials:
affiliation: Instituto Nacional de Rehabilitacion
name: TANIA I NAVA-BRINGAS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.
citation: 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.