跳至主要内容
临床试验/CTRI/2024/12/077686
CTRI/2024/12/077686招募中不适用

Development, Validation, and Effectiveness of the SRIHER Knee Pain Screening Tool with Targeted Therapy in Physiotherapy Primary Care: A Randomized Controlled Clinical Trial

Sri Ramachandra Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年12月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
152
试验地点
1
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

研究概览

简要总结

BACKGROUND

According to estimates from the World Health Organization, 9.6% of men and 18% of women worldwide have symptomatic osteoarthritis in their older years. According to United Nations research, by 2050, over 20% of the world’s population will be over 60 years old.

Individuals with Knee osteoarthritis (KOA) experience pain and disability more frequently than any other chronic health condition. Although knee osteoarthritis is a complex condition, it usually consists of unified subgroups or phenotypes. Therapeutic exercise is strongly advised in addition to diet and pain medication as the initial course of treatment. OA knee pain is difficult to diagnose in primary care, and both patients and healthcare professionals may find it irritating that there isn’t a well-established biological model and stratified rehabilitation program to support the pain and guide first physical therapy choices.

They lack consideration of biological, psychological, and social interventions. We aimed to develop and validate an SRIHER knee pain screening and targeted therapy tool to identify prognostic indicators relevant to physical therapists’ clinical decision-making concerning initial treatment options in physiotherapy primary care. Also, to find the effectiveness of the SRIHER knee pain screening and targeted therapy tool on enhancing the outcomes among musculoskeletal knee pain individuals in physiotherapy primary care. There are minimal numbers of studies available globally with stratified rehabilitation programs addressing musculoskeletal knee pain and impairments. No study has been conducted with a randomized controlled trial design for a stratified knee rehabilitation program.

AIM OF THE STUDY

This study aims to develop a valid tool to screen, categorize, and deliver targeted therapy to individuals with musculoskeletal knee pain.

To evaluate the effectiveness of the SRIHER knee pain screening tool with targeted therapy on enhancing the outcomes among musculoskeletal knee pain individuals in physiotherapy primary care using physical function.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Participants with Knee Pain aged above 18 to 55 years -Participants with sufficient English language comprehension -Participants who gave consent to participate in the study.

排除标准

  • Participants with severe knee OA, in whom knee replacement is indicated. -Participants with a history of hip OA, lower limb joint replacement/ surgery, spine surgery -Participants with corticoid injection within the past one month. -Participants with any congenital or acquired deformity in the spine or lower limb -Participants Diagnosed with comorbidities.
  • neurological conditions, psychiatric conditions, systemic diseases/cancer -Participants not able to come for follow ups / not willing to participate in the study -Participants with suspicion of chronic widespread pain.

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

时间窗: at Baseline, at the end of the 1st week, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week

30-Second Chair Stand Test

时间窗: at Baseline, at the end of the 1st week, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week

次要结局

  • Global perceived effect

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Soundararajan K

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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