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临床试验/NCT04826263
NCT04826263Unknown不适用

Comparison of the Effectiveness of Low-level Laser Therapy and Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment

Trakya University0 个研究点目标入组 48 人开始时间: 2021年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
48
主要终点
Cadence

研究概览

简要总结

The aim of this study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) in terms of pain, disability, activity limitation, gait speed, and cadence in patients with plantar fasciitis (PF).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Experience pain on the medial tuberosity or medial process of plantar fascia within the past one month
  • •Diagnosed with plantar fasciitis

排除标准

  • •arthritis in the foot or ankle
  • •Cardiac arrhythmia or pacemaker
  • •Previous foot or ankle surgery
  • •Cancer or tumor, acute trauma
  • •BMI over 40 kg/m2
  • •Corticosteroid injection in the last 6 months

研究组 & 干预措施

ESWT Group

Experimental

The patients in the ESWT group will receive ESWT treatment and a home exercise program.

干预措施: Home Exercise Program (Other)

ESWT Group

Experimental

The patients in the ESWT group will receive ESWT treatment and a home exercise program.

干预措施: Extracorporeal Shockwave Therapy (ESWT) (Other)

LLLT Group

Experimental

The patients in the LLLT Group will receive LLLT treatment and a home exercise program.

干预措施: Home Exercise Program (Other)

LLLT Group

Experimental

The patients in the LLLT Group will receive LLLT treatment and a home exercise program.

干预措施: Low-Level Laser Therapy (LLLT) (Other)

结局指标

主要结局

Cadence

时间窗: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)

Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. Cadence will be measured by the number of steps in the walking test.

Gait Speed

时间窗: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)

Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. The subjects walking time will be recorded in seconds. Gait speed will be measured by dividing the 100 meters distance by the patients' walking time.

Foot Function Index (FFI)

时间窗: It will be reported at the end of treatment (3 weeks)

FFI is a valid and reliable self-administered questionnaire that can evaluate the pain, activity limitation, and disability caused by foot and ankle disorders. A modified version of the Foot Function Questionnaire developed by Venditto et al. will be used for the study, which comprises 17 items (17-IFFI) separated into three subscales; pain (5 items), disability (9 items), and activity limitation (3 items). The VAS in the original version has been substituted with the Numerical Rating Scale (NRS) which is an 11-point scale from 0 to 10. The modified version of FFI has been reported to be a reliable and valid scale and its use has been recommended for musculoskeletal foot and ankle disorders including plantar fasciitis.

Foot Function Index (FFI)

时间窗: It will be reported at baseline

FFI is a valid and reliable self-administered questionnaire that can evaluate the pain, activity limitation, and disability caused by foot and ankle disorders. A modified version of the Foot Function Questionnaire developed by Venditto et al. will be used for the study, which comprises 17 items (17-IFFI) separated into three subscales; pain (5 items), disability (9 items), and activity limitation (3 items). The VAS in the original version has been substituted with the Numerical Rating Scale (NRS) which is an 11-point scale from 0 to 10. The modified version of FFI has been reported to be a reliable and valid scale and its use has been recommended for musculoskeletal foot and ankle disorders including plantar fasciitis.

Gait Speed

时间窗: It will be reported at baseline (5 minutes after the FFI)

Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. The subjects walking time will be recorded in seconds. Gait speed will be measured by dividing the 100 meters distance by the patients' walking time.

Cadence

时间窗: It will be reported at baseline (5 minutes after the FFI)

Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. Cadence will be measured by the number of steps in the walking test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halit SELÇUK

Principal Investigator

Trakya University

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