Athletic InjuryPCMALBPNCT02969785
Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain
A study testing G1: exercises for lumbar stabilization and G2: back strengthening exercises in people with Athletic Injury and Low Back Pain, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Injury, Low Back Pain
- What is being tested?
- G1: exercises for lumbar stabilization and G2: back strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 31 Dec 2022
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- previous surgery (locomotor appareil).
- discal herniation diagnosis.
- nerve root entrapment.
- spondylolisis.
- spondylolisthesis;
- lumbar stenosis.
Show all 11Show fewer
- hip cartilage damage.
- labral injury,
- piriformis syndrome.
- neurological disease.
- no current treatment in Physiotherapy or Pilates or Manual Therapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
Londrina, Paraná, 86041-120
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletic Injury, Low Back Pain
- Being tested
- G1: exercises for lumbar stabilization, G2: back strengthening exercises
- Keywords
- Postural control, Physiotherapy, Sports injuries, Low back pain, training
- Medical subject headings
- Athletic Injuries, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G1: exercises for lumbar stabilizationOther
Also called therapeutic exercises
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.
G2: back strengthening exercisesOther
Also called Back resistive training
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.
| Study group | Role | What they receive |
|---|---|---|
| G1: exercises for lumbar stabilization | Experimental | 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. Receives: Other: G1: exercises for lumbar stabilization |
| G2: back strengthening exercises | Active comparator | 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. Receives: Other: G2: back strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eletromyography measurement
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.
Measured: Change from baseline muscular activation at 8 weeks
Secondary outcomes (1)
Force platform measurement
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
Measured: Change from baseline muscular activation at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Sep 2017
- Primary completion28 Apr 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Alexandre da Silva Jr, Universidade Norte do Paraná
- Investigators
- Rubens da Silva, PhD, Study director, Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969785
- Sponsor's protocol ID
- Rubens A. da Silva
- Acronym
- PCMALBP
- Status last verified
- May 2023
- First submitted
- 11 Nov 2016
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25681408Moon 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.
PubMed 23525973Cairns 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.
PubMed 16946640McGill 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.
PubMed 19154838
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Athletes Chronic With Low Back Pain: A Feasibility and Clinical Trial Study
- ClinicalTrials.gov ID
- NCT02969785
- Acronym / sponsor ID
- PCMALBP / Rubens A. da Silva
- Conditions
- Athletic Injury, Low Back Pain
- Keywords
- Postural control, Physiotherapy, Sports injuries, Low back pain, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Nov 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1: exercises for lumbar stabilization | Experimental | Other: G1: exercises for lumbar stabilizationSpecific 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. |
| G2: back strengthening exercises | Active comparator | Other: G2: back strengthening exercisesBack 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- previous surgery (locomotor appareil).
- discal herniation diagnosis.
- nerve root entrapment.
- spondylolisis.
- spondylolisthesis;
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 |
|---|---|---|
| G1: exercises for lumbar stabilizationAlso: therapeutic exercisesSpecific 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 | G1: exercises for lumbar stabilization |
| G2: back strengthening exercisesAlso: Back resistive trainingSpecific 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 | G2: back strengthening exercises |
Primary outcome
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.
1 secondary outcome
Force platform measurement
Time frame: Change from baseline muscular activation at 8 weeks
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 10 May 2023.
- Background: PubMed 25681408Searle 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.
- Background: PubMed 23525973Moon 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.
- Background: PubMed 16946640Cairns 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.
- Background: PubMed 19154838McGill 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.
- Individual participant dataSharing planned: No
Related trials for Athletic Injury
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Recruiting
Intelligent Sports Injury Prevention and Training System
Sport Injury
RecruitingObservational study
Multimodal Machine Learning for Predicting Reduced Participation in Elite Youth Football
Athletic Injury, Fatigue Recovery
Not yet recruitingObservational study
Investigation of Injury Risk and Related Factors in Adolescent Male Soccer Players
Injury;Sports, Athletic Injuries
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.
Rubens da Silva, PhD study director
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G1: exercises for lumbar stabilization and G2: back strengthening exercises in people with Athletic Injury and Low Back Pain, run by Universidade Norte do Paraná at 1 site in Brazil.
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 11 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 10 May 2023. 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 Brazil. 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?
Eletromyography measurement (time frame: Change from baseline muscular activation at 8 weeks). 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 NCT02969785, which also lists 4 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 10 May 2023.