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临床试验/NCT06917937
NCT06917937已完成不适用

The Additive Effect of Exercise in Addition to Corticosteroid Injection for Pain and Functional Performance in Plantar Fasciitis: A Single-Center Randomized Clinical Study

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Muscle Shortness Tests

研究概览

简要总结

Plantar fasciitis (PF) involves the degeneration of the medial calcaneal tuberosity and nearby perifascial tissues in the heel. It is the leading cause of heel pain, typically resulting from repetitive strain on the plantar fascia, causing structural damage. Key risk factors for PF include an increased body mass index in active individuals and a greater range of plantar flexion motion. Treatment options for PF vary, and there is no clear consensus on the most effective approach. Conservative treatments may include rest, stretching exercises for the plantar fascia and Achilles tendon, strengthening exercises for foot intrinsic muscles, nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics, heel pads, dorsiflexion night splints, and corticosteroid injections. These treatments may be used individually or in combination. Corticosteroid injections are the most frequently used invasive treatment. However, there has been limited research examining the effects of corticosteroid injections combined with exercises targeting intrinsic foot muscle strength on functionality and walking distance. The objective of this study was to evaluate the impact of an exercise program added to corticosteroid injections on pain relief and functional performance in individuals with 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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Those over the age of 18
  • •Those who have pain in the plantar region for 1 month and this pain is 5 or more according to VAS,
  • •Those who describe pain on the first step of the morning,
  • •Those with plantar fascia tenderness on palpation,
  • •Patients who will be in harmony with the physician and physiotherapist in exercise and follow-up throughout the entire study period.

排除标准

  • •Cases with fracture, entrapment neuropathy and rupture,
  • •Those with neurological and systemic diseases,
  • •Those with a Body Mass Index (BMI) of more than 40,
  • •Conditions with a local contraindication to corticosteroid,
  • •Participants who have situations that may prevent their safety, execution or interpretation of the results during the continuation of the training and applied of the test protocol.

研究组 & 干预措施

(Exercise program in added on to corticosteroid injection (Group I)

Experimental

Our exercise program in our study; (i) foot intrinsic muscle strengthening exercise (with a load of 3 kg), (ii) plantar fascia stretching with finger extension, (iii) standing gastrocnemius muscle stretching, (iv) sitting achilles tendon stretching, (v) plantar fascia and gastrocnemius stretch on the step, (vi) cold massage exercise in the arch of the foot. We stated that the group to which exercise was added should do the exercises regularly for 6 weeks, in the specified number and time.

干预措施: Exercise Program (Other)

(Exercise program in added on to corticosteroid injection (Group I)

Experimental

Our exercise program in our study; (i) foot intrinsic muscle strengthening exercise (with a load of 3 kg), (ii) plantar fascia stretching with finger extension, (iii) standing gastrocnemius muscle stretching, (iv) sitting achilles tendon stretching, (v) plantar fascia and gastrocnemius stretch on the step, (vi) cold massage exercise in the arch of the foot. We stated that the group to which exercise was added should do the exercises regularly for 6 weeks, in the specified number and time.

干预措施: Corticosteroid injection (Other)

Corticosteroid injection (Group II)

Active Comparator

The orthopedic physician administered the corticosteroid injection as a mixture of 1 ml of arthropane (5 mg of triamcinolone hexacetonide) and 4 ml of citanest. Before the application, the physician cleaned the area to be treated with 10% povidone iodine. He made a single dose injection by entering the painful point determined by palpation around the calcaneal spur and plantar fascia from the percutaneous foot-heel lateral. The patients were in the prone position with the ankle in a neutral position.

干预措施: Corticosteroid injection (Other)

结局指标

主要结局

Muscle Shortness Tests

时间窗: a day before the rehabilitation

Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

Muscle Shortness Tests

时间窗: up to 3 weeks

Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

时间窗: a day before the rehabilitation

The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

时间窗: up to 3 weeks

The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

时间窗: a day before the rehabilitation

This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

时间窗: up to 3 weeks

This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

Foot Function Index

时间窗: a day before the rehabilitation

It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

Foot Function Index

时间窗: up to 3 weeks

It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

6-minute walk test

时间窗: a day before the rehabilitation

The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

6-minute walk test

时间窗: up to 3 weeks

The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

50 meters walking test

时间窗: a day before the rehabilitation

The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

50 meters walking test

时间窗: up to 3 weeks

The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

Visual Analogue Scale

时间窗: a day before the rehabilitation

Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

Visual Analogue Scale

时间窗: up to 3 weeks

Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

Muscle Shortness Tests

时间窗: up to 6 weeks

Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

时间窗: up to 6 weeks

The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

时间窗: up to 6 weeks

This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

Foot Function Index

时间窗: up to 6 weeks

It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

6-minute walk test

时间窗: up to 6 weeks

The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

50 meters walking test

时间窗: up to 6 weeks

The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

Visual Analogue Scale

时间窗: up to 6 weeks

Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevtap Cakir

Asst. Prof.

Kutahya Health Sciences University

研究点 (1)

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