Degenerative SpondylolisthesisNCT02664688
Lumbar Stabilization Exercises vs Flexor Exercises in Degenerative Spondylolisthesis
A study testing Lumbar stabilization exercises and Flexor exercises in people with Degenerative Spondylolisthesis and Chronic Low Back Pain, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
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)" Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Spondylolisthesis, Chronic Low Back Pain
- What is being tested?
- Lumbar stabilization exercises and Flexor exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of lumbar surgery,
- Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc.
- Cauda equine symptoms,
- Ischemic heart disease
- Diabetic polyneuropathy
- Illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis
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)"
Read the 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.
- Being tested
- Lumbar stabilization exercises, Flexor exercises
- Keywords
- spondylolisthesis, low back pain, stabilization exercise
- Medical subject headings
- Spondylolisthesis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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")
Flexor exercisesOther
Also called Williams exercises
The home-exercise program included a hot pack for 15 minutes and flexor exercises routine
| Study group | Role | What they receive |
|---|---|---|
| Lumbar stabilization exercises | Experimental | Home exercise program to perform daily for 6 months Receives: Other: Lumbar stabilization exercises |
| Flexor Exercises | Active comparator | Home exercise program to perform daily for 6 months Receives: Other: Flexor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain (VAS)
Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."
Measured: 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)
Measured: At baseline, 4 weeks, 3 months and 6 months
Secondary outcomes (1)
Change in use of analgesics
Total number of days consuming analgesics in the 30 days prior to the evaluation.
Measured: At baseline, 4 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tania Ines Nava-Bringas, Instituto Nacional de Rehabilitacion
- Investigators
- TANIA I NAVA-BRINGAS, MSc, Principal investigator, Instituto Nacional de Rehabilitacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664688
- Sponsor's protocol ID
- 19/15
- Status last verified
- Mar 2018
- First submitted
- 20 Jan 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23948848Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.
PubMed 25238480Nava-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.
PubMed 33792726
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis
- ClinicalTrials.gov ID
- NCT02664688
- Acronym / sponsor ID
- 19/15
- Keywords
- spondylolisthesis, low back pain, stabilization exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar stabilization exercises | Experimental | Other: Lumbar stabilization exercisesHome exercise program to perform daily for 6 months |
| Flexor Exercises | Active comparator | Other: Flexor exercisesHome exercise program to perform daily for 6 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- History of lumbar surgery,
- Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc.
- Cauda equine symptoms,
- Ischemic heart disease
- Diabetic polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar stabilization exercisesThe 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") | Other | Lumbar stabilization exercises |
| Flexor exercisesAlso: Williams exercisesThe home-exercise program included a hot pack for 15 minutes and flexor exercises routine | Other | Flexor Exercises |
Primary outcome
Change in Pain (VAS)
Time frame: At baseline, 4 weeks, 3 months and 6 months
Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."
Change in Disability (The Roland Morris Scale)
Time frame: At baseline, 4 weeks, 3 months and 6 months
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)
1 secondary outcome
Change in use of analgesics
Time frame: At baseline, 4 weeks, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 23948848Nava-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.
- Results publication: PubMed 25238480Vasquez-Rios JR, Nava-Bringas TI. [Lumbar stabilization exercises]. Cir Cir. 2014 May-Jun;82(3):352-9. Spanish.
- Derived from this study: PubMed 33792726Nava-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TANIA I NAVA-BRINGAS, MSc principal investigator
Instituto Nacional de Rehabilitacion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar stabilization exercises and Flexor exercises in people with Degenerative Spondylolisthesis and Chronic Low Back Pain, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (VAS) (time frame: At baseline, 4 weeks, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664688, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.