- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969785
Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain (PCMALBP)
May 8, 2023 updated by: Rubens Alexandre da Silva Jr, Universidade Norte do Paraná
An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Athletes Chronic With Low Back Pain: A Feasibility and Clinical Trial Study
The relevance of this study is given by the feasibility to assess the effect of an intervention program based on the postural control and trunk neuromuscular activity, comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes with low back pain.
The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control.
Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed.
This is the first study to compare two intervention methods using the main biological outcomes related to trunk neuromuscular function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For this study, a proposal of a 8-week intervention program will be carried out with lumbar stabilization exercises and back strengthening exercises, in 32 athletes with chronic low back, recruited by convenience and voluntaries from the community local and sports centers.
Before intervention, all participantes will be evaluated by: electromoyography during back endurance and strength tests, balance performance, physical capacity, and by clinical outcomes such as pain, disability and psychological factors.
All baseline testing and evaluation will be performed by a blinded evaluator to the study intervention.
Afterwards, the participants will be randomized in two groups by a blinded evaluator (people not enroled to study): G1: exercises for lumbar stabilization; and G2: strengthening exercises.
The intervention will follow 8 weeks, with 50 minutes of duration each session of therapy including measurement of blood pressure, heart rate and the Visual Analogue Scale (VAS) before and after each session, and the perception of exercise intensity monitored by Borg Scale.
Within this proposal, the exercise sessions will performed twice a week.
The intervention will follow the CONSORT recommendations for randomized controlled trials.
The intervention will start in: G1 (n=16, motor control group), which will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource; while G2 (n=16, strength group) will perform back endurance progressive and resisted exercises on a Roman chair.
The participants will not be blind to the study due to the characteristic of the exercises that often reflect to the improvement of the symptoms.
In case of eventual losses, the intention-to-treat method will be used for the analyses.
After the intervention, all groups will be invited to come back to the laboratory to proceed the same evaluation from baseline (trunk activation during exercises, balance, and clinical outcomes).
For the analysis two-way ANOVA with repeated measures will be performed to compare the effects of the intervention (two groups) and times (baseline vs. end 8-weeks measurement) and the effects of interaction (Groups x Times).
The size effect also will be computed to determine the rate of the changes observed.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rubens da Silva, PhD
- Phone Number: 011 55 43 3371-9848
- Email: rubens@unopar.br
Study Locations
-
-
Paraná
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Londrina, Paraná, Brazil, 86041-120
- Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- chronic low back pain at least for three months, in a unique or multiple episodes.
- low back pain of unknown origin and mechanical nature.
- athletes must be train or play five times in a week.
- athletes must be participate in some official competition.
Exclusion Criteria:
- previous surgery (locomotor appareil).
- discal herniation diagnosis.
- nerve root entrapment.
- spondylolisis.
- spondylolisthesis;
- lumbar stenosis.
- hip cartilage damage.
- labral injury,
- piriformis syndrome.
- neurological disease.
- no current treatment in Physiotherapy or Pilates or Manual Therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G1: exercises for lumbar stabilization
Specific exercises for lumbar stabilization.
The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
|
Specific exercises for lumbar stabilization.
The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
Other Names:
|
Active Comparator: G2: back strengthening exercises
Back strengthening exercises.
The Group 2 (G2) will perform therapy including strengthning of back muscles on a Roman chair machine for flexion and extension of trunk with load progression from training volume for endurance and strength gains.
|
Specific back exercises.
The Group 2 (G2) will perform therapy including back strengthing exercise on a Roman chair machine to perform flexion and extension of trunk with load progressive training.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eletromyography measurement
Time Frame: Change from baseline muscular activation at 8 weeks
|
EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) and Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back activation during strength maximal protocol and endurance dynamic test.
|
Change from baseline muscular activation at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Force platform measurement
Time Frame: Change from baseline muscular activation at 8 weeks
|
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
|
Change from baseline muscular activation at 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogic Scale
Time Frame: Change from baseline muscular activation at 8 weeks
|
Pain measurement using Short Version of Pain Questionnaire McGill (score 0 to 78; while higher score is determined by poor condition related to pain) and Visual Analogue Scale for pain intensity (score of 0 to 10 intensity; being 10 of poor score for VAS).
|
Change from baseline muscular activation at 8 weeks
|
Disability questionnaire
Time Frame: Change from baseline muscular activation at 8 weeks
|
Disability measurement using Oswestry questionnaire.
|
Change from baseline muscular activation at 8 weeks
|
Fear-avoidance questionnaire
Time Frame: Change from baseline muscular activation at 8 weeks
|
Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.
|
Change from baseline muscular activation at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rubens da Silva, PhD, Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
- Cairns MC, Foster NE, Wright C. Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain. Spine (Phila Pa 1976). 2006 Sep 1;31(19):E670-81. doi: 10.1097/01.brs.0000232787.71938.5d.
- Moon HJ, Choi KH, Kim DH, Kim HJ, Cho YK, Lee KH, Kim JH, Choi YJ. Effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain. Ann Rehabil Med. 2013 Feb;37(1):110-7. doi: 10.5535/arm.2013.37.1.110. Epub 2013 Feb 28.
- McGill SM, Karpowicz A. Exercises for spine stabilization: motion/motor patterns, stability progressions, and clinical technique. Arch Phys Med Rehabil. 2009 Jan;90(1):118-26. doi: 10.1016/j.apmr.2008.06.026.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
November 11, 2016
First Submitted That Met QC Criteria
November 16, 2016
First Posted (Estimate)
November 21, 2016
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rubens A. da Silva
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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