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临床试验/NCT06347406
NCT06347406Unknown不适用

Effects of Combined Physiotherapy Management and Education on Physiological Functions and Quality of Life Among Individuals With Patellofemoral Pain

Fakulti Sains Kesihatan2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
128
试验地点
2
主要终点
The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)

研究概览

简要总结

This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:

  • Are there any effects of combined physiotherapy program among individuals with PFPS on:

i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be

  • Measure for the anthropometrics data including body weight, height, and BMI.
  • Answer the Numerical Pain Rating scale
  • Abswe Malay version of KOOS-PF and TAMPA scale.
  • Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive
  • Blood flow restrictions cuff with physiotherapy exercises
  • Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life

详细描述

The participants who volunteered will be screened for inclusion and exclusion criteria. Prior to the assessments and examinations, the physiotherapist in charge will explain the study and will get consent from the participants. This study will follow the Consort RCT 2010 guidelines.

Then the participants will go into randomization sequence before they go into the interventions. The participants will go into block randomization. The participants will be blocks into color (Blue for Experimental group, Red for control group). This study will be double blinded. The blinded person will be the accessors and the participants.

Then they will complete the demographic questionnaire which will include questions on personal data, health status, medical illness, past medical history, simple questions on their pain, site of pain with the assistance by the researchers to read the questions as most of the participants is illiterate.

Then the participants will be measure for the anthropometric data including body weight, height and BMI.

The participants will answer the Numerical Pain Rating scale, KOOS-PF Malay version and TAMPA scale. Then they will proceed with station 1 (HHD which measure strength), station 2 (Real time ultrasound which measure muscle bulk) and then station 3 (Dartfish motion analysis for knee functional performance test (anteromedial lunge, step-down, single-leg press, bilateral squat, and balance and reach) using the Dartfish software.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pain and disability in at least three of the following activities involving pain around the patella
  • Scored in KOOS-PF

排除标准

  • Failure to regularly continue treatment sessions
  • A history of knee surgery and severe trauma with meniscus or ligament tear within 6 months
  • Went for acupuncture treatment
  • Undergone any type of surgical procedure
  • Pregnancy, cancer, secondary osteoarthritis and various rheumatologic diseases, and symptoms of abnormal neurological examination of sensation, movement, and reflexes

结局指标

主要结局

The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)

时间窗: 4 months

The KOOS-PF subscale is used to assess pain and function in the patellofemoral joint. The 11-point KOOS-PF, which was created in collaboration with healthcare professionals, demonstrated adequate measuring qualities and is recommended for clinical and research usage in patients suffering from patellofemoral pain

Tampa Scale

时间窗: 4 months

The Tampa Kinesiophobia Scale (TSK) is a self-assessment measure used to determine a person's fear of movement-related pain who suffers from musculoskeletal discomfort

Numerical Pain Rating

时间窗: 4 months

On a Numerical Pain Rating Scale, often known as an NPRS, patients are asked to circle the number between 0 and 10, 0 and 20, or 0 and 100 that most properly portrays the intensity of pain that they are experiencing

Hand held dynamometer (HDD)

时间窗: 4 months

The examiner holds a small portable gadget against the patient's limb during a maximal isometric contraction. The equipment can test both the proximal and distal muscles of all extremitie

Knee Muscle performance Test with Dartfish software

时间窗: 4 months

Dartfish data will be used to process the action of anteromedial lunge, step-down, bilateral squat, and balance and reach during simultaneous digital video acquisition. In other words, Dartfish programme will generate data. All of these movements will be measured with Dartfish software

Real time ultrasounds

时间窗: 4 months

The thickness and length of the superficial quadriceps muscles (VMO, VL, VL, and RF).

次要结局

未报告次要终点

研究者

发起方
Fakulti Sains Kesihatan
申办方类型
Other
责任方
Sponsor

研究点 (2)

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