RBR-3db643c Manual Therapy plus advice to stay active in patients with chronic leg pain

Date of registration: 06/10/2021 ^(mm/dd/yyyy)
Last approval date : 10/08/2026 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1264-4772

• Public title:

  en

  Manual Therapy plus advice to stay active in patients with chronic leg pain

  pt-br

  Terapia manual adicionada a orientação para manter-se ativo em pacientes com dor na perna crônica

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 40500720.8.0000.5235
    Issuing authority: Plataforma Brasil
  • 8.776.869
    Issuing authority: Comitê de Ética em Pesquisa da Centro Universitário Augusto Motta

Sponsors

• Primary sponsor: Centro Universitário Augusto Motta
• Secondary sponsor:
  • Institution: Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Sciatica

  pt-br

  Ciática

• General descriptors for health conditions:

  en

  C23.888.592.612.107.400 Low Back Pain

  pt-br

  C23.888.592.612.107.400 Dor Lombar

• Specific descriptors:

  en

  C23.888.592.612.107.400 Sciatica

  pt-br

  C23.888.592.612.107.400 Ciática

Interventions

• Interventions:

  en

  This was a two-arm, parallel-group, randomised controlled superiority trial with blinded outcome assessment and blinded statistical analysis. The planned sample size was 210 participants, with allocation in a 1:1 ratio between the experimental and control groups. A total of 107 participants were effectively randomised, with 55 allocated to the experimental group and 52 to the control group. Randomisation was performed using a computer-generated sequence with randomly permuted block sizes, and allocation was concealed using sequentially numbered, sealed, opaque envelopes. Participants and treating physiotherapists could not be blinded. However, outcome assessors and the statistician were blinded to group allocation. The experimental group received advice to stay active combined with neural management, whereas the control group received advice to stay active alone. Advice to stay active was delivered in five individual, face-to-face sessions at two-week intervals over ten weeks, lasting approximately 30 minutes each. Neural management was delivered only to the experimental group in ten weekly sessions over ten weeks, lasting approximately 30 minutes each, and included soft tissue mobilisation, joint mobilisation, and neural mobilisation of the sciatic nerve, with progression according to symptom response and tolerance.

  pt-br

  Este foi um ensaio clínico controlado, randomizado, de superioridade, com dois braços e grupos paralelos, com avaliação de desfechos e análise estatística mascaradas. A amostra prevista era de 210 participantes, com alocação em proporção 1:1 entre os grupos experimental e controle. Um total de 107 participantes foram efetivamente randomizados, sendo 55 alocados no grupo experimental e 52 no grupo controle. A randomização foi realizada utilizando uma sequência gerada por computador com tamanhos de bloco permutados aleatoriamente, e o sigilo da alocação foi garantido pelo uso de envelopes opacos, lacrados e numerados sequencialmente. Não foi possível mascarar os participantes nem os fisioterapeutas responsáveis pelo tratamento. No entanto, os avaliadores dos desfechos e o estatístico permaneceram mascarados em relação à alocação dos grupos. O grupo experimental recebeu orientações para manter-se ativo combinadas com gerenciamento do tecido neural, enquanto o grupo controle recebeu apenas orientações para manter-se ativo. As orientações para manter-se ativo foram fornecidas em cinco sessões individuais presenciais, com intervalos de duas semanas ao longo de dez semanas, com duração aproximada de 30 minutos cada. O gerenciamento do tecido neural foi aplicado apenas ao grupo experimental em dez sessões semanais ao longo de dez semanas, com duração aproximada de 30 minutos cada, incluindo mobilização de tecidos moles, mobilização articular e mobilização neural do nervo ciático, com progressão baseada na resposta dos sintomas e na tolerância.

• Descriptors:

  en

  E02.190.599 Musculoskeletal Manipulations

  pt-br

  E02.190.599 Manipulações Musculosqueléticas

  en

  I02.233.332 Health Education

  pt-br

  I02.233.332 Educação em Saúde

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 04/04/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  210	-	18 Y	65 Y

• Inclusion criteria:

  en

  Adults with chronic sciatica; moderate or severe leg pain intensity; 18-65 years old; both sexes

  pt-br

  Participantes que apresentem ciatalgia crônica; intensidade de dor na perna moderada ou severa; idade entre 18 e 65 anos; ambos os sexos

• Exclusion criteria:

  en

  Participants in treatment due to sciatica; participants planning to undergo any other procedures for sciatica treatment in the study period; present known or signs of serious spinal pathology; history of abdominal, lumbar, or lower limb surgery in the past year; rheumatologic disease in the acute inflammatory phase; if they are receiving disability compensation due to LBP; pregnant or puerperal women; self-reported psychiatric diagnosis; history of cancer; and cancer-related pain

  pt-br

  Participantes que estejam realizando algum tratamento para ciatalgia; participantes que planejam realizar algum outro procedimento para ciatalgia no período do estudo; apresentarem sinais de patologia vertebral grave; histórico de cirurgia abdominal, lombar ou nos membros inferiores no último ano; doença reumatológica em fase inflamatória aguda; se estiverem recebendo benefício trabalhista devido à dor lombar; gestantes ou puérperas; diagnóstico psiquiátrico autorreferido; histórico de câncer; e dor relacionada ao câncer

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Leg pain intensity and functional limitation were evaluated in patients with chronic sciatica by comparing the group that received neural management combined with advice to stay active with the group that received advice to stay active alone. Greater reductions in pain intensity and greater improvements in functional limitation were expected in the experimental group over the short-, medium-, and long-term follow-up periods.

  pt-br

  Foi avaliada a intensidade da dor nas pernas e a limitação funcional em pacientes com ciatalgia crônica, comparando-se o grupo que recebeu gerenciamento do tecido neural associado à orientação para manter-se ativo com o grupo que recebeu apenas orientação para manter-se ativo. Esperava-se observar maior redução da intensidade da dor e maior melhora da funcionalidade no grupo experimental ao longo dos períodos de acompanhamento de curto, médio e longo prazo.

• Secondary outcomes:

  en

  Neuropathic symptoms, sciatic neurodynamic measures, pain modulation, and psychosocial factors were evaluated. It was expected that participants in the experimental group would show greater improvement in sciatic neurodynamic measures after the treatment period compared with the control group. Baseline participant characteristics were analysed to identify factors associated with self-reported pain perception, and mediator analyses were performed to investigate potential factors that could explain clinical improvement in participants with chronic sciatica undergoing the study interventions.

  pt-br

  Foram avaliados os sintomas neuropáticos, as medidas neurodinâmicas do nervo ciático, a modulação da dor e os fatores psicossociais. Esperava-se que os participantes do grupo experimental apresentassem maior melhora das medidas neurodinâmicas do nervo ciático após o período de tratamento em comparação ao grupo controle. As características iniciais dos participantes foram analisadas para identificar os fatores mais relevantes associados à percepção autorreferida da dor. Além disso, foram realizadas análises de mediação para investigar potenciais fatores capazes de explicar a melhora clínica dos participantes com ciatalgia crônica submetidos às intervenções do estudo.

Summary Results

• Url for protocol: https://pmc.ncbi.nlm.nih.gov/articles/PMC8815873/

• Results summary:

  en

  Advice to stay active is the primary management strategy for sciatica. Other conservative treatments such as neural management techniques may also contribute to sciatica recovery, but currently, the effects have not been robustly assessed. Thus, the aim of this study is to compare the effects of adding neural management to advice to stay active versus advice to stay active alone in improving pain intensity and functional limitation. Secondarily, to compare the effects of the experimental intervention in the sciatic neurodynamic, pain modulation, and psychosocial factors. A parallel-group, controlled, examiner-blinded superiority clinical trial randomised at a 1:1 allocation will be conducted in 210 participants with chronic sciatica. Patients will be recruited from outpatient physiotherapy clinics and community advertisements. The experimental group will receive neural mobilisation techniques and soft tissue mobilisation techniques for 30 minutes per session, 10 weekly sessions, plus advice to stay active on their activities of daily living, information on physical activity, imaging tests, and sciatica for 5 biweekly sessions lasting 25–30 minutes. The control group will receive advice to stay active only. The re-evaluation will be performed out after 5 weeks, 10 weeks, and 26 weeks after randomisation and primary endpoints will be pain intensity and functional limitation at 10 weeks. Secondary outcomes will include neuropathic symptoms, sciatic neurodynamic, pain modulation, and psychosocial factors. Adverse events and patient satisfaction will be assessed. Ethical approval has been granted from an Institutional Human Research Ethics Committee.

Data Sharing Plan

• Data Sharing Plan:

  en

  No

  pt-br

  No

  es

  No

Contacts

• Public contact
  • Full name: Juliana Valentim Bittencourt
  • • Address: Av. Paris, 84 - Bonsucesso - Rio de Janeiro - RJ
    • City: Rio de Janeiro / Brazil
    • Zip code: 21041-020
  • Phone: +55 (24) 98815-0866
  • Email: julianavalentim@souunisuam.com.br
  • Affiliation: Centro Universitário Augusto Motta
  • Full name: Leticia Amaral Corrêa
  • • Address: Av. Paris, 84 - Bonsucesso
    • City: Rio de Janeiro / Brazil
    • Zip code: 21041-020
  • Phone: +55 (21) 97910-0168
  • Email: leticiaamaral@souunisuam.com.br
  • Affiliation: Centro Universitário Augusto Motta
   
• Scientific contact
  • Full name: Leandro Alberto Calazans Nogueira
  • • Address: Av. Paris, 84 - Bonsucesso - Rio de Janeiro - RJ
    • City: Rio de Janeiro / Brazil
    • Zip code: 21041-020
  • Phone: +55 (21) 3882-9797
  • Email: leandronogueira@souunisuam.com.br
  • Affiliation: Centro Universitário Augusto Motta
   
• Site contact
  • Full name: Arthur de Sá Ferreira
  • • Address: Av. Paris, 84 - Bonsucesso - Rio de Janeiro - RJ
    • City: Rio de Janeiro / Brazil
    • Zip code: 21041-020
  • Phone: +55 (21) 3882-9797
  • Email: arthurde@souunisuam.com.br
  • Affiliation: Centro Universitário Augusto Motta
   

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