RBR-7pbcdw Low back pain during pregnancy: relationship between lumbar curvature, pain and stretching.

Date of registration: 05/18/2015 ^(mm/dd/yyyy)
Last approval date : 05/18/2015 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1167-8969

• Public title:

  en

  Low back pain during pregnancy: relationship between lumbar curvature, pain and stretching.

  pt-br

  Dor lombar na gestação: relação entre a curvatura lombar, dor e alongamento.

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 21423413.1.0000.0102
    Issuing authority: Plataforma Brasil - SISNEP
  • 504.452
    Issuing authority: Comitê de Ética em Pesquisa envolvendo seres humanos do Setor de Ciências da Saúde da UFPR (CEP/SD)

Sponsors

• Primary sponsor: Universidade Federal do Paraná
• Secondary sponsor:
  • Institution: Hospital Municipal de Matinhos
• Supporting source:
  • Institution: Universidade Federal do Paraná

Health conditions

• Health conditions:

  en

  Gestacional Low back pain

  pt-br

  Dor lombar gestacional

• General descriptors for health conditions:

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Condiciones patológicas, signos y síntomas

• Specific descriptors:

Interventions

• Interventions:

  en

  32 women of Paraná coast were evaluated within the period of 6 months through: 1) semi-structured questionnaire to collect gestational history; 2) Questionnaire validated for evaluation of low back disability index (Oswestry Disability Questionnaire); 3) Nordic Musculoskeletal Questionnaire to assess the presence of musculoskeletal symptoms; 4) Goniometry lumbar spine to assess the range of motion active; 5) Shober test to evaluate the lumbar flexibility; 6) as the thoracic and lumbar angle by validated protocol flexicurve and 7) Back Performance Scale (BPS) to check the overall mobility and physical performance in women with pain

  pt-br

  32 gestantes do Litoral do Paraná foram avaliadas dentro do período de 6 meses por meio de: 1) questionário semi-estruturado para coleta de histórico gestacional; 2) Questionário validado para avaliação do índice de incapacidade lombar (Questionário de Incapacidade de Oswestry) ; 3) Questionário Nórdico de Sintomas Osteomusculares para avaliar a presença de sintomas musculoesqueléticos; 4) Goniometria da coluna lombar para avaliar a amplitude articular ativa; 5) Teste de Shober para avaliar a flexibilidade lombar; 6) medida do ângulo torácico e lombar por meio de protocolo validado com flexicurva e 7) Back Performance Scale (BPS) para verificar a mobilidade geral e o desempenho físico em gestantes com dor nas costas

• Descriptors:

  en

  SP1.011.122 Health Evaluation

  pt-br

  SP1.011.122 Avaliação em Saúde

  es

  SP1.011.122 Evaluación en Salud

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 07/01/2014 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  32	F	18 Y	40 Y

• Inclusion criteria:

  en

  pregnant women enrolled in Happy Mother Program of the Department of Pontal do Paraná Health and the Municipal Prenatal Program for Health Matinhos; aged between 18-40 years; with gestational age greater than or equal to 20 weeks.

  pt-br

  Gestantes inscritas no Programa Mãe Feliz da Secretaria de Saúde de Pontal do Paraná e no Programa de Pré-Natal da Secretaria Municipal de Saúde de Matinhos; com idade variando entre 18 a 40 anos; idade gestacional igual ou maior a 20 semanas.

• Exclusion criteria:

  en

  Pregnant women diagnosed with high-risk pregnancy; twin pregnancy; presence of cognitive / mental disabilities; urinary tract infection; previous herniated disc; previous surgery in the spine, pelvis, hip or knee; presence of musculoskeletal or neurological dysfunction

  pt-br

  Gestantes com diagnóstico de gestação de alto risco; gestação gemelar; presença de deficiência cognitiva/mental; infecção do trato urinário; hérnia de disco prévia; cirurgia prévia na coluna vertebral, pelve, quadril ou joelho; presença de disfunção musculoesquelética ou neurológica.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Diagnostic	Single-group	0	N/A	N/A	N/A

Outcomes

• Primary outcomes:

  en

  It is expected to find moderate statistical correlation (greater than 0.30) suggesting that gestational age increases the lumbar angle measured by flexicurve and the presence of low back pain identified by the Nordic questionnaire musculoskeletal symptoms

  pt-br

  Espera-se encontrar correlação estatística moderada (maior que 0,30) sugerindo que maior idade gestacional aumenta o ângulo lombar mensurado por flexicurva e a presença de dor lombar identificada pelo questionário nórdico de sintomas osteomusculares

• Secondary outcomes:

  en

  It is expected to find moderate statistical correlation (greater than 0.30), suggesting that the higher the lumbar angle measured by flexicurve, the greater the range of motion of the lumbar region measured by goniometer and greater flexibility measured by Schober test

  pt-br

  Espera-se encontrar correlação estatística moderada (maior que 0,30) sugerindo que quanto maior o ângulo lombar mensurado por flexicurva, maior será a amplitude de movimento da região lombar mensurada por goniometria e maior será a flexibilidade mensurada pelo Teste de Schober

Contacts

• Public contact
  • Full name: Raciele Ivandra Guarda Korelo
  • • Address: Avenida Coronel Francisco Heráclito dos Santos, 210
    • City: Curitiba / Brazil
    • Zip code: 81531-980
  • Phone: +55 (41) 9177 6161
  • Email: raciele_guarda@yahoo.com.br
  • Affiliation: Universidade Federal do Paraná
   
• Scientific contact
  • Full name: Raciele Ivandra Guarda Korelo
  • • Address: Avenida Coronel Francisco Heráclito dos Santos, 210
    • City: Curitiba / Brazil
    • Zip code: 81531-980
  • Phone: +55 (41) 9177 6161
  • Email: raciele_guarda@yahoo.com.br
  • Affiliation: Universidade Federal do Paraná
   
• Site contact
  • Full name: Raciele Ivandra Guarda Korelo
  • • Address: Avenida Coronel Francisco Heráclito dos Santos, 210
    • City: Curitiba / Brazil
    • Zip code: 81531-980
  • Phone: +55 (41) 9177 6161
  • Email: raciele_guarda@yahoo.com.br
  • Affiliation: Universidade Federal do Paraná
   

Additional links:

• Download in ICTRP format