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

2026년 7월 10일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 파키스탄
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, 파키스탄
        • 모병
        • Shahab Orthopedic and General Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 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.
절차: 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.
실험적: 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.
절차: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain Intensity Measured by the Visual Analogue Scale (VAS)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ibadat International University, Islamabad

수사관

  • 수석 연구원: Dr Zahid Mehmood, Ibadat International University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 17일

기본 완료 (추정된)

2026년 7월 6일

연구 완료 (추정된)

2026년 7월 7일

연구 등록 날짜

최초 제출

2026년 7월 4일

QC 기준을 충족하는 최초 제출

2026년 7월 4일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 10일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Ref: IIUI/RERC/ADT/2026/02/258

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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