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Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis

10 de agosto de 2026 atualizado por: Riphah International University

Effects of Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Pain, Kinesiophobia, and Functional Disability in Diabetic Adhesive Capsulitis

The purpose of this study is to determine the effects of Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy on pain, kinesiophobia, central sensitization, functional disability, range of motion, and quality of life in patients with Type II diabetic adhesive capsulitis. Adhesive capsulitis is a common musculoskeletal condition characterized by pain and progressive restriction of shoulder movement, particularly among individuals with diabetes mellitus. Conventional physiotherapy is widely used to restore shoulder mobility and function; however, it may not adequately address central sensitization and fear of movement. Pain Neuroscience Education aims to improve patients' understanding of pain mechanisms and reduce maladaptive beliefs, while Graded Motor Imagery targets cortical reorganization and movement-related fear. The combination of these interventions with conventional physiotherapy may improve clinical outcomes and enhance quality of life.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study is a randomized controlled trial with a parallel-group design to evaluate the effectiveness of Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy in patients with Type II diabetic adhesive capsulitis. A total of 50 participants meeting the inclusion and exclusion criteria will be recruited using a non-probability convenience sampling technique and randomly allocated into two groups.

  • Experimental Group: Participants will receive Pain Neuroscience Education, Graded Motor Imagery, and conventional physiotherapy.
  • Control Group: Participants will receive conventional physiotherapy alone. Both groups will undergo treatment for 6 weeks, with three treatment sessions per week. The experimental intervention will include weekly Pain Neuroscience Education sessions, progressive Graded Motor Imagery (laterality recognition, motor imagery, and mirror therapy), along with conventional physiotherapy consisting of joint mobilization, stretching, strengthening, range-of-motion exercises, and functional training.

Outcome assessments will be performed at baseline (Week 0), mid-treatment (Week 3), and post-treatment (Week 6). The primary outcome measures will include pain intensity (Numeric Pain Rating Scale), shoulder range of motion (Universal Goniometer), functional disability (Shoulder Pain and Disability Index), kinesiophobia (Tampa Scale of Kinesiophobia), and central sensitization (Central Sensitization Inventory). Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire. The findings of this study will determine whether adding Pain Neuroscience Education and Graded Motor Imagery to conventional physiotherapy provides superior improvements in pain, psychological outcomes, functional ability, and quality of life compared with conventional physiotherapy alone.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Paquistão
    • Capital Territory
      • Islamabad, Capital Territory, Paquistão, 44000
        • RIPHAH International hospital Islamabad
        • Contato:
          • Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
          • Número de telefone: +92 333-2238706
    • Punjab Province
      • Rawalpindi, Punjab Province, Paquistão, 46000
        • IIMCT-Railway General Hospital
        • Contato:
          • Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
          • Número de telefone: +92 333-2238706

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Diagnosed cases of adhesive capsulitis (Stage I or II)
  • Diagnosed with Type II Diabetes Mellitus
  • Age between 40-65 years
  • Shoulder pain lasting more than 3 months
  • Limited shoulder range of motion.

Exclusion Criteria:

  • Previous shoulder surgery
  • History of fracture or dislocation of shoulder
  • Cervical radiculopathy
  • Neurological disorders
  • Severe diabetic complications
  • Cognitive impairments.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental Group (PNE + GMI + Conventional Physiotherapy)
Participants assigned to the experimental group will receive Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy. The intervention will be delivered over 6 weeks, with three supervised treatment sessions per week. Pain Neuroscience Education will address pain neurophysiology, central sensitization, fear-avoidance beliefs, coping strategies, and self-management. Graded Motor Imagery will include laterality recognition, motor imagery, and mirror therapy, progressing according to the treatment protocol. Conventional physiotherapy will consist of shoulder range-of-motion exercises, joint mobilization, stretching, strengthening, proprioceptive training, functional exercises, and activity-specific rehabilitation.
Comportamental: Pain Neuroscience Education (PNE)
Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.
Outros nomes:
  • Arm/group, experimental (PNE)
Comportamental: Graded Motor Imagery (GMI)
Progressive intervention consisting of laterality recognition, explicit motor imagery, and mirror therapy to improve cortical reorganization, reduce kinesiophobia, and restore shoulder function.
Outro: Conventional Physiotherapy
Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.
Comparador Ativo: Control Group (Conventional Physiotherapy)
Participants assigned to the control group will receive conventional physiotherapy alone for 6 weeks, with three supervised treatment sessions per week. Treatment will include pain relief modalities, shoulder range-of-motion exercises, stretching, joint mobilization, strengthening exercises, proprioceptive exercises, functional training, and activity-specific rehabilitation without Pain Neuroscience Education or Graded Motor Imagery.
Outro: Conventional Physiotherapy
Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain intensity measured by Numeric Pain Rating Scale (NPRS)
Prazo: Baseline (Week 0), Week 3, and Week 6
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). The Numeric Pain Rating Scale (NPRS) is a self-reported outcome measure used to assess pain intensity in musculoskeletal and rehabilitation settings. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Baseline (Week 0), Week 3, and Week 6
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI).
Prazo: Baseline (Week 0), Week 3, and Week 6
Functional disability will be evaluated using the Shoulder Pain and Disability Index (SPADI). The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire developed to assess pain and functional disability associated with shoulder disorders, particularly adhesive capsulitis and other musculoskeletal shoulder conditions. The SPADI consists of 13 items divided into two subscales: a pain subscale containing 5 items and a disability subscale containing 8 items. Each item is scored using a numerical rating scale ranging from 0 to 10, where 0 represents "no pain" or "no difficulty" and 10 represents "worst pain imaginable". Higher scores indicate greater pain and disability.
Baseline (Week 0), Week 3, and Week 6
Shoulder Range of Motion Measured Using a Universal Goniometer
Prazo: Baseline (Week 0), Week 3, and Week 6
Active shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be measured using a universal goniometer.
Baseline (Week 0), Week 3, and Week 6
Kinesiophobia Measured by the Tampa Scale of Kinesiophobia (TSK-17).
Prazo: Baseline (Week 0), Week 3, and Week 6
Kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia (TSK-17).The Tampa Scale of Kinesiophobia (TSK) is a self-reported questionnaire used to assess fear of movement, fear of reinjury, and avoidance behaviors associated with pain and musculoskeletal disorders.The most commonly used version is the TSK-17, which consists of 17 items assessing beliefs related to physical activity and movement-related fear. Each item is scored on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia and fear-avoidance behavior.
Baseline (Week 0), Week 3, and Week 6
Central Sensitization Measured by the Central Sensitization Inventory (CSI).
Prazo: Baseline (Week 0), Week 3, and Week 6
Central sensitization will be assessed using the Central Sensitization Inventory (CSI). The Central Sensitization Inventory (CSI) is a self-reported questionnaire developed to identify symptoms associated with central sensitization in individuals with chronic pain disorders. The CSI consists of 25 items that assess health-related symptoms commonly associated with central sensitization syndromes. Each item is scored on a 5-point Likert scale ranging from 0 ("never") to 4 ("always"). Higher scores indicate greater symptoms related to central sensitization.
Baseline (Week 0), Week 3, and Week 6

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
Prazo: Baseline (Week 0), Week 3, and Week 6
The Short Form-36 (SF-36) is a widely used self-reported questionnaire designed to assess health-related quality of life in individuals with acute and chronic health conditions. The SF-36 consists of 36 items divided into eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain score is transformed into a scale ranging from 0 to 100, where higher scores indicate better health-related quality of life.
Baseline (Week 0), Week 3, and Week 6

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Riphah International University

Investigadores

  • Investigador principal: Huma Riaz, Riphah International University, Islamabad

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de agosto de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

31 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2026

Primeira postagem (Real)

13 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Rasheeda

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared because the data are confidential and were collected solely for the purposes of this research study. Participant privacy and institutional policies will be maintained.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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