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

NCT02933086 | Completed DMC

• 1 other identifier: 1.579.189
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Low Back Pain

Keywords

Pregnant; Low Back Pain; Postural Control

Outcome Measures

Primary Outcomes (1)

• Eletromyography measurement

  Level of muscular activaity of trunk from eletromyography surface processing.

  Change from baseline muscular activation at 6 weeks

Secondary Outcomes (1)

• Force platform measurement

  Change from baseline balance performance at 6 weeks

Other Outcomes (3)

• Visual Analogic Scale

  Change from baseline pain intensity at 6 weeks.

• Disability questionnaire

  Change from baseline disability status at 6 weeks.

• Fear-avoidance questionnaire

  Change from baseline Fear-avoidance status at 6 weeks.

Study Arms (2)

G1: exercises for lumbar stabilization

EXPERIMENTAL

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

Other: Specific exercises for lumbar stabilization

G2: conventional therapy

EXPERIMENTAL

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

Other: Conventional therapy

Interventions

Specific exercises for lumbar stabilization OTHER

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.

G1: exercises for lumbar stabilization

Conventional therapy OTHER

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.

G2: conventional therapy

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Londrina, Paraná, 86041-120, Brazil

Location

Related Publications (4)

• 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.

  PMID: 25840522 BACKGROUND

• 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.

  PMID: 26422811 BACKGROUND

• 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.

  PMID: 18259783 BACKGROUND

• 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.

  PMID: 24500508 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications; Low Back Pain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubens A da Silva Jr., Phd

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

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: Titular professor

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: July 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

BR (1)