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

An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant 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 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Pregnancy Complications
• Intervention / Treatment: Other: Specific exercises for lumbar stabilization; Other: Conventional therapy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86041-120
      • Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G1: exercises for lumbar stabilization; G1, will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource	Other: 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.
Experimental: G2: conventional therapy; G2, will perform conventional therapy including stretching of lower limbs and trunk.	Other: Conventional therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eletromyography measurement	Level of muscular activaity of trunk from eletromyography surface processing.	Change from baseline muscular activation at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force platform measurement	Force platform measurement during balance performance using centre of pressure measures to assess balance performance.	Change from baseline balance performance at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogic Scale	Pain measurement using Short Version of Pain Questionnaire Mc Gill and Visual Analogue Scale (VAS).	Change from baseline pain intensity at 6 weeks.
Disability questionnaire	Disability measurement using Roland Morris questionnaire.	Change from baseline disability status at 6 weeks.
Fear-avoidance questionnaire	Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.	Change from baseline Fear-avoidance status at 6 weeks.

Collaborators and Investigators

• Sponsor: Universidade Norte do Paraná
• Investigators: Principal Investigator: Rubens A da Silva Jr., Phd, Universidade Norte do Paraná

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Low Back Pain; Pregnant; Postural Control
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Pregnancy Complications
• Other Study ID Numbers: 1.579.189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED