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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1: exercises for lumbar stabilization | Experimental | G1, will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource |
|
| G2: conventional therapy | Experimental | G2, will perform conventional therapy including stretching of lower limbs and trunk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eletromyography measurement | Level of muscular activaity of trunk from eletromyography surface processing. | Change from baseline muscular activation at 6 weeks |
| 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 |
| 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. |
The inclusion criteria were:
The exclusion criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| Rubens A da Silva Jr., Phd | Universidade Norte do Paraná | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Functional Assessment and Human Motor Performance (LAFUP) | Londrina | Paraná | 86041-120 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25840522 | Background | 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. | |
| 26422811 | 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. |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
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|
| 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. |
|
| 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. |
| 18259783 | 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. |
| 24500508 | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |