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An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain

Primary Purpose

Pregnancy Complications, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Specific exercises for lumbar stabilization
Conventional therapy
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Complications focused on measuring Pregnant, Low Back Pain, Postural Control

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

The inclusion criteria were:

  • Have between 19-29 weeks of pregnancy;
  • Have performed prenatal clinical monitoring;
  • Have chronic low back pain (> 3 months) without irradiation for knees.
  • Not being under medication or physical therapy treatment for low back pain in the last three months;
  • To be able to perform physical activity consistent to the pregnancy;
  • To present normal conditions of responsiveness, cognition and speaking;
  • To be voluntary.

The exclusion criteria were:

  • Signs or symptoms of other pathology including coexisting pathology, a recent history (within 3 months) of surgery in the locomotor system;
  • Respiratory, neurological or cardiovascular diseases.
  • Several musculoskeletal disorders.
  • Limitations for physical exercise.
  • Allergic reaction to adhesive tape,

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

G1: exercises for lumbar stabilization

G2: conventional therapy

Arm Description

G1, will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource

G2, will perform conventional therapy including stretching of lower limbs and trunk.

Outcomes

Primary Outcome Measures

Eletromyography measurement
Level of muscular activaity of trunk from eletromyography surface processing.

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
October 10, 2016
Last Updated
September 5, 2018
Sponsor
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT02933086
Brief Title
An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain
Official Title
An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain: A Feasibility and Clinical Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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 functionality and trunk neuromuscular activity and postural control in pregnant women 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 segment function.
Detailed Description
For this study, a proposal of a 6-week intervention program will be carried out with lumbar stabilization exercises and clinical orientations, on 20 low back pregnant patients recruited by convenience and voluntaries from the community. Before intervention, all participantes will be evaluated by: electromoyography during three exercises, balance, and 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: conventional therapy. The intervention will follow six 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 be twice a week, lasting 40 minutes each, and followed by 10 minutes of theoretical orientation. The intervention will follow the CONSORT recommendations for randomized controlled trials. The intervention will start in: G1 (n=10), which will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource; while G2 (n=10, control group) will perform conventional therapy including stretching of lower limbs and trunk. 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 three 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 6-weeks measurement)the effects of interaction (Groups x Times).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Low Back Pain
Keywords
Pregnant, Low Back Pain, Postural Control

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
G1: exercises for lumbar stabilization
Arm Type
Experimental
Arm Description
G1, will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource
Arm Title
G2: conventional therapy
Arm Type
Experimental
Arm Description
G2, will perform conventional therapy including stretching of lower limbs and trunk.
Intervention Type
Other
Intervention Name(s)
Specific exercises for lumbar stabilization
Intervention Description
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)
Conventional therapy
Intervention Description
The Group 2 (G2) will perform conventional therapy including stretching of lower limbs and trunk, with passive stretching of hamstrings; gluteus maximus; piriform; paraspinals; lumbar square; latissimus dorsi; scalene; trapezius.
Primary Outcome Measure Information:
Title
Eletromyography measurement
Description
Level of muscular activaity of trunk from eletromyography surface processing.
Time Frame
Change from baseline muscular activation at 6 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 balance performance at 6 weeks
Other Pre-specified Outcome Measures:
Title
Visual Analogic Scale
Description
Pain measurement using Short Version of Pain Questionnaire Mc Gill and Visual Analogue Scale (VAS).
Time Frame
Change from baseline pain intensity at 6 weeks.
Title
Disability questionnaire
Description
Disability measurement using Roland Morris questionnaire.
Time Frame
Change from baseline disability status at 6 weeks.
Title
Fear-avoidance questionnaire
Description
Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.
Time Frame
Change from baseline Fear-avoidance status at 6 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criteria were: Have between 19-29 weeks of pregnancy; Have performed prenatal clinical monitoring; Have chronic low back pain (> 3 months) without irradiation for knees. Not being under medication or physical therapy treatment for low back pain in the last three months; To be able to perform physical activity consistent to the pregnancy; To present normal conditions of responsiveness, cognition and speaking; To be voluntary. The exclusion criteria were: Signs or symptoms of other pathology including coexisting pathology, a recent history (within 3 months) of surgery in the locomotor system; Respiratory, neurological or cardiovascular diseases. Several musculoskeletal disorders. Limitations for physical exercise. Allergic reaction to adhesive tape,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens A da Silva Jr., Phd
Organizational Affiliation
Universidade Norte do Paraná
Official's Role
Principal Investigator
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
Undecided
Citations:
PubMed Identifier
25840522
Citation
O'Keeffe M, O'Sullivan P, Dankaerts W, O'Sullivan K. Swiss ball enhances lumbar multifidus activity in chronic low back pain: A letter to the editor. Phys Ther Sport. 2015 May;16(2):202-3. doi: 10.1016/j.ptsp.2015.03.001. Epub 2015 Mar 11. No abstract available.
Results Reference
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PubMed Identifier
26422811
Citation
Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015 Sep 30;2015(9):CD001139. doi: 10.1002/14651858.CD001139.pub4.
Results Reference
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PubMed Identifier
18259783
Citation
Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
Results Reference
background
PubMed Identifier
24500508
Citation
Madeira HG, Garcia JB, Lima MV, Serra HO. [Disability and factors associated with gestational low back pain]. Rev Bras Ginecol Obstet. 2013 Dec;35(12):541-8. doi: 10.1590/s0100-72032013001200003. Portuguese.
Results Reference
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An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain

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