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Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain (PCMALBP)

Primary Purpose

Athletic Injury, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
G1: exercises for lumbar stabilization
G2: back strengthening exercises
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Athletic Injury focused on measuring Postural control, Physiotherapy, Sports injuries, Low back pain, training

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G1: exercises for lumbar stabilization

G2: back strengthening exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Force platform measurement
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.

Full Information

First Posted
November 11, 2016
Last Updated
May 8, 2023
Sponsor
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT02969785
Brief Title
Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain
Acronym
PCMALBP
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injury, Low Back Pain
Keywords
Postural control, Physiotherapy, Sports injuries, Low back pain, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1: exercises for lumbar stabilization
Arm Type
Experimental
Arm Description
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.
Arm Title
G2: back strengthening exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
G1: exercises for lumbar stabilization
Other Intervention Name(s)
therapeutic exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
G2: back strengthening exercises
Other Intervention Name(s)
Back resistive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eletromyography measurement
Description
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.
Time Frame
Change from baseline muscular activation at 8 weeks
Secondary Outcome Measure Information:
Title
Force platform measurement
Description
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
Time Frame
Change from baseline muscular activation at 8 weeks
Other Pre-specified Outcome Measures:
Title
Visual Analogic Scale
Description
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).
Time Frame
Change from baseline muscular activation at 8 weeks
Title
Disability questionnaire
Description
Disability measurement using Oswestry questionnaire.
Time Frame
Change from baseline muscular activation at 8 weeks
Title
Fear-avoidance questionnaire
Description
Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.
Time Frame
Change from baseline muscular activation at 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens da Silva, PhD
Organizational Affiliation
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86041-120
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25681408
Citation
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.
Results Reference
background
PubMed Identifier
23525973
Citation
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.
Results Reference
background
PubMed Identifier
16946640
Citation
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.
Results Reference
background
PubMed Identifier
19154838
Citation
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.
Results Reference
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Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain

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