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Ice Packs Versus Cold Baths Combined With Standard Exercise Therapy for Plantar Fasciitis

10 de julho de 2026 atualizado por: Ibadat International University, Islamabad

Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis

This randomized controlled trial aims to compare the effectiveness of ice pack therapy and cold bath immersion when combined with standard exercise therapy in adults with plantar fasciitis. Plantar fasciitis is a common cause of heel pain that can limit daily activities and reduce quality of life. Participants will be randomly assigned to receive either ice pack therapy or cold bath therapy in addition to the same standardized exercise program. The primary outcome will be pain intensity measured using the Visual Analogue Scale (VAS), and the secondary outcome will be foot function measured using the Foot Function Index (FFI). The findings of this study may help identify the more effective cryotherapy method for reducing pain and improving function in individuals with plantar fasciitis.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Plantar fasciitis is one of the most common causes of plantar heel pain and is associated with functional limitations, reduced mobility, and impaired quality of life. Conservative management is considered the first-line treatment and typically includes therapeutic exercises, stretching, strengthening, patient education, and cryotherapy. Although cryotherapy is widely used to relieve pain and reduce tissue inflammation, there is limited evidence comparing the effectiveness of different cryotherapy modalities in patients with plantar fasciitis.

This study is a prospective, parallel-group, randomized controlled trial designed to compare the clinical effectiveness of ice pack application and cold bath immersion when both are combined with a standardized exercise therapy program.

Eligible adults diagnosed with plantar fasciitis will be randomly allocated into one of two intervention groups:

Group A: Ice pack therapy combined with standard exercise therapy. Group B: Cold bath immersion combined with standard exercise therapy.

Both groups will receive identical exercise therapy consisting of plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training. Cryotherapy will be administered for 10 minutes per session, five sessions per week, for two weeks.

The primary outcome will be pain intensity measured using the Visual Analogue Scale (VAS). The secondary outcome will be functional disability measured using the Foot Function Index (FFI). Outcome assessments will be performed at baseline and immediately after completion of the two-week intervention period.

The study hypothesizes that one cryotherapy modality may provide superior pain relief and functional improvement when combined with standard exercise therapy. The results are expected to provide evidence for selecting the most effective, low-cost, and easily applicable cryotherapy intervention for conservative management of plantar fasciitis and may contribute to evidence-based physiotherapy practice.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

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

Estude backup de contato

Locais de estudo

  • Paquistão
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Paquistão
        • Recrutamento
        • Shahab Orthopedic and General Hospital
        • Contato:

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:

  • Adults aged 18 to 65 years.
  • Clinical diagnosis of unilateral or bilateral Plantar Fasciitis.
  • Heel pain localized to the medial calcaneal tubercle.
  • Positive Windlass test.
  • Pain intensity of ≥4 on the Visual Analogue Scale (VAS) at baseline.
  • Willing and able to provide written informed consent.
  • Willing to comply with the study protocol and attend all treatment and assessment sessions.

Exclusion Criteria:

  • History of foot or ankle surgery within the previous 6 months.
  • Corticosteroid injection for plantar fasciitis within the previous month.
  • Neurological disorders affecting the lower limb.
  • Peripheral vascular disease or other vascular disorders affecting the lower limb.
  • Open wounds, skin infections, or contraindications to cryotherapy.
  • Pregnancy.
  • Participation in another interventional clinical trial during the study period.
  • Inability to follow the study protocol or complete outcome assessments.

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Ice Pack + Standard Exercise Therapy
Participants assigned to this arm will receive ice pack therapy in combination with a standardized exercise therapy program. Ice packs will be applied to the plantar aspect of the affected foot for 10 minutes per session, five sessions per week for two weeks. The exercise program includes plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training.
Procedimento: Ice Pack Therapy
Ice pack therapy will be administered by applying crushed ice or a commercial gel ice pack wrapped in a thin towel to the plantar aspect of the heel and medial longitudinal arch of the affected foot. The intervention will be applied for 10 minutes per session, five sessions per week for two weeks. Skin integrity will be assessed before and after treatment to minimize the risk of cold-related injury.
Procedimento: Standard Exercise Therapy
All participants will receive the same standardized exercise therapy program consisting of plantar fascia stretching, gastrocnemius and soleus stretching, eccentric heel raises, and balance training. Supervised sessions will be conducted five times per week for two weeks, with participants instructed to continue home exercises on non-supervised days. The exercise program is identical for both intervention groups.
Experimental: Cold Bath + Standard Exercise Therapy
Participants assigned to this arm will receive cold bath immersion in combination with the same standardized exercise therapy program. The affected foot will be immersed in cold water maintained at 10-15°C for 10 minutes per session, five sessions per week for two weeks. The exercise program includes plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training.
Procedimento: Standard Exercise Therapy
All participants will receive the same standardized exercise therapy program consisting of plantar fascia stretching, gastrocnemius and soleus stretching, eccentric heel raises, and balance training. Supervised sessions will be conducted five times per week for two weeks, with participants instructed to continue home exercises on non-supervised days. The exercise program is identical for both intervention groups.
Procedimento: Cold Water Immersion
Cold water immersion will be administered by immersing the affected foot up to the malleoli in water maintained at 10-15°C for 10 minutes per session, five sessions per week for two weeks. Water temperature will be monitored before each treatment session, and participants will be observed for discomfort or excessive numbness throughout the intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain Intensity Measured by the Visual Analogue Scale (VAS)
Prazo: Baseline and at the end of the 2-week intervention period
Pain intensity will be assessed using the 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will rate heel pain experienced during the first steps in the morning and during daily activities. A reduction in the VAS score indicates improvement.
Baseline and at the end of the 2-week intervention period
Foot Function Measured by the Foot Function Index (FFI)
Prazo: Baseline and at the end of the 2-week intervention period
Functional status will be evaluated using the Foot Function Index (FFI), a validated questionnaire that measures pain, disability, and activity limitation associated with foot disorders. Scores range from 0% to 100%, with lower scores indicating better foot function.
Baseline and at the end of the 2-week intervention period

Colaboradores e Investigadores

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

Patrocinador

Ibadat International University, Islamabad

Investigadores

  • Investigador principal: Dr Zahid Mehmood, Ibadat International University

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 (Real)

17 de fevereiro de 2026

Conclusão Primária (Estimado)

6 de julho de 2026

Conclusão do estudo (Estimado)

7 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

4 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de julho de 2026

Primeira postagem (Real)

10 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Ref: IIUI/RERC/ADT/2026/02/258

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 made publicly available because the study is an investigator-initiated academic research project, and participant confidentiality and privacy will be protected in accordance with institutional ethical requirements. De-identified aggregate data will be reported in publications and presentations. Requests for additional study information may be considered by the principal investigator and the institutional ethics committee, subject to applicable ethical and regulatory requirements.

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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