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临床试验/NCT02890485
NCT02890485
招募中
不适用

The Effects of Dry Needling on Patients With Knee Pain

Ohio State University1 个研究点 分布在 1 个国家目标入组 120 人2016年8月1日

概览

阶段
不适用
干预措施
Dry Needling
疾病 / 适应症
Patellofemoral Pain Syndrome
发起方
Ohio State University
入组人数
120
试验地点
1
主要终点
Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks
状态
招募中
最后更新
2个月前

概览

简要总结

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

详细描述

This project will evaluate the effects of dry needling on pain, muscle performance, and function in those with patellofemoral pain syndrome (PFPS) of the knee. Variables of interest will include self-reported pain scores, self-reported functional outcome and disability questionnaire scores, and various objective clinical measures including muscle strength, joint range of motion, and movement patterns during basic tasks related to activities of daily living. Patients who are referred to physical therapy with PFPS will be recruited. Patients will be randomly and equally allocated into one of the following groups: 1. Gluteal dry needling (GLUTE) 2. Quadriceps dry needling (QUAD) 3. Sham gluteal dry needling (SHAM GLUTE) 4. Sham quadriceps dry needling (SHAM QUAD) 5. Control group (CONTROL) Groups 1-4 will receive 2 sessions of dry needling or sham dry needling to the gluteal and/or quadricpes muscles on their painful lower limb over 2 consecutive weeks in addition to standard physical therapy. The CONTROL group will only receive standard physical therapy. The sham treatment groups (groups 3-4) will receive a placebo treatment that does not penetrate the skin or muscles. Measurements will be performed at baseline prior to any physical therapy interventions and then at week 3.

注册库
clinicaltrials.gov
开始日期
2016年8月1日
结束日期
2030年12月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Factorial
性别
All

研究者

责任方
Principal Investigator
主要研究者

Matt Briggs

Assistant Professor-Practice

Ohio State University

入排标准

入选标准

  • 18-40 years-of-age
  • Referred for physical therapy
  • Presence of anterior knee pain around the patella during ascending/descending stairs, squatting, and/or running for at least 3 months.

排除标准

  • Unable to provide consent
  • Bilateral patellofemoral pain syndrome
  • Received previous dry needling treatments
  • Pregnancy
  • History of pain less than 3 months
  • Imaging demonstrating the presence of confounding internal abnormality (e.g. chondral defects, ligamentous injury, and/or meniscal pathology),
  • Patellar instability
  • Presence of a neurological condition that would affect movement
  • Contraindications to dry needling techniques (e.g. a history of bleeding disorders, phobia of needles, an active cancer diagnosis, and presence of other systemic illness such as fever or signs of infection)
  • Actively receiving treatment for knee pain outside of the current study protocol while enrolled in the study;

研究组 & 干预措施

Glute Dry Needling

Receives dry needling to their gluteal muscles in addition to standard physical therapy treatment.

干预措施: Dry Needling

Quad Dry Needling

Receives dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

干预措施: Dry Needling

Glute Sham Dry Needling

Receives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment.

干预措施: Sham Dry Needling

Quad Sham Dry Needling

Receives sham dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

干预措施: Sham Dry Needling

Control

Receives only standard physical therapy treatment.

干预措施: Physical Therapy

结局指标

主要结局

Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks

时间窗: Baseline and Post testing (week 3)

The AKPS is commonly used to evaluate function in patients with PFPS. It is a 13-item questionnaire with a maximum score of 100. Higher scores are indicative of better function. The minimal detectable change (MDC) and the minimal clinically important difference (MCID) of the AKPS has been reported to be 10 and 13 points respectively and has high test-retest reliability (ICC: 0.81 to 0.95). The standard error of measurement is 3 and has been shown to be valid (0.92).

Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks

时间窗: Baseline and Post testing (week 3)

Pain will be measured using the numeric pain rating scale (NPRS). Patients will be asked to rate their pain on 11-point (0-10) scale with 0 being no pain and 10 being extreme pain. The NPRS is a common measure of pain in patients with PFPS and has been shown to be reliable and responsive (minimal clinically important difference = 2 points).

次要结局

  • Change from Baseline Lateral step-down (LSD) test score to 3 weeks(Baseline and Post testing (week 3))
  • Change from Baseline Isometric knee and hip peak torque values to 3 weeks(Baseline and Post testing (week 3))
  • Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks(Baseline and Post testing (week 3))
  • Change from Baseline Pressure Pain Threshold to 3 weeks(Baseline and Post testing (week 3))

研究点 (1)

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