NCT02969785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.7 years

First QC Date

November 11, 2016

Last Update Submit

May 8, 2023

Conditions

Keywords

Postural controlPhysiotherapySports injuriesLow back paintraining

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline muscular activation at 8 weeks

Secondary Outcomes (1)

  • Force platform measurement

    Change from baseline muscular activation at 8 weeks

Other Outcomes (3)

  • Visual Analogic Scale

    Change from baseline muscular activation at 8 weeks

  • Disability questionnaire

    Change from baseline muscular activation at 8 weeks

  • Fear-avoidance questionnaire

    Change from baseline muscular activation at 8 weeks

Study Arms (2)

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.

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.

Other: G2: back strengthening exercises

Interventions

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.

Also known as: therapeutic exercises
G1: exercises for lumbar stabilization

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.

Also known as: Back resistive training
G2: back strengthening exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Londrina, Paraná, 86041-120, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 25681408BACKGROUND
  • 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.

    PMID: 23525973BACKGROUND
  • 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.

    PMID: 16946640BACKGROUND
  • 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.

    PMID: 19154838BACKGROUND

MeSH Terms

Conditions

Athletic InjuriesLow Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Wounds and InjuriesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Rubens da Silva, PhD

    Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 21, 2016

Study Start

September 1, 2017

Primary Completion

April 28, 2021

Study Completion

December 31, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations