Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis

Chronic Low Back Pain Clinical Trial

Official title:

Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664688
• Other study ID #: 19/15
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: National Institute of Rehabilitation, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Degenerative Spondylolisthesis
• Low Back Pain
• Spondylolisthesis

Intervention

Other:
• Lumbar stabilization exercises
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")
• Flexor exercises
The home-exercise program included a hot pack for 15 minutes and flexor exercises routine

Locations

Country	Name	City	State
Mexico	INRMexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Rehabilitation, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Nava-Bringas TI, Hernández-López M, Ramírez-Mora I, Coronado-Zarco R, Israel Macías-Hernández S, Cruz-Medina E, Arellano-Hernández A, León-Hernández SR. Effects of a stabilization exercise program in functionality and pain in patients with degenerative sp — View Citation

Vásquez-Ríos JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Review. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in use of analgesics	Total number of days consuming analgesics in the 30 days prior to the evaluation.	At baseline, 4 weeks, 3 months and 6 months