A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up
研究概览
简要总结
The purpose of this study is to compare outcomes of combined chiropractic care in anterior knee pain patients with patellofemoral pain syndrome.
详细描述
Exercise is standard of care for PFPS but gives limited pain reduction and functional improvement. Previous manipulative therapy for PFPS (with and without exercise) has been limited to the patellofemoral joint alone. However, literature suggests additional manipulative therapy with exercise and soft-tissue treatment may give a better outcome. Further research is needed.
Therefore, this project is a pilot study to inform a future randomized controlled trial to determine if chiropractic adjusting of the full lower extremity (lumbosacral through foot) combined with exercise and soft tissue treatment (Protocol and group A) is superior to chiropractic adjusting of the knee (alone) combined with exercise and soft tissue treatment (Protocol and group B) in the treatment of patellofemoral pain syndrome. We will use the Anterior Knee Pain Scale (AKPS) and Visual Analogue Scale (VAS) as valid and reliable primary outcome measures, a functional measure (step-ups, step-downs and squats) and a Patient Satisfaction Scale (PSS - discharge or refer) as secondary outcome measures. This study will help establish the feasibility of conducting quality research at Cleveland Chiropractic College Los Angeles.
In this pilot study there will be two groups of 10 subjects each
- Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston Instrument Soft Tissue Mobilization hereafter GISTM)
- Group B will receive CMT to the lumbosacral, sacroiliac and (all) lower extremity joints, exercise and soft tissue treatment (GISTM).
Enrolled subjects will receive a total of 6 treatments. The primary endpoint will be a 2 month follow-up after the 6th treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anterior, peri or retropatellar knee pain >3 months from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping or overuse activities. Pain is relieved by rest.
- •insidious onset of symptoms unrelated to a traumatic incident; and
- •presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat
- •other disorders such as OA, instability or medial meniscus injury must be ruled out
- •X-ray or MRI findings not required. There is no clear correlation between severity of complaints and arthroscopic or radiologic findings
- •A VAS-Worst pain of ≥ 5.0; a AKPS of ≥ 50.This reflects the current probability that less PFPS patients with less severity currently consult chiropractors for this disorder
排除标准
- •Patellar subluxation/dislocation
- •meniscal injuries
- •intra-articular pathology (ACL injury, etc)
- •ligament laxity
- •Osgood-Schlatters
- •Sinding-Larsen-Johanson syndrome
- •knee joint effusion
- •previous surgery on patellofemoral joint
- •illiteracy/inability to understand and answer questionnaires
- •inability to attend all treatment sessions
- •true locking of knee joint
- •a neurological disorder that influences gait
- •if taking medication, amount will be diarized - otherwise not allowed
- •foot orthotics allowed if already worn
- •arthritidies
- •patellar tendonitis
- •older subjects > 45 years of age
- •subjects < 18 years of age
- •those that begin marked ↑ in physical activity during the course of the trial
结局指标
主要结局
Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up
时间窗: Baseline, 6th Treatment, 2 Month Follow-Up
Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up
时间窗: Baseline, 6th Treatment, 2 Month Follow-Up
次要结局
- a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up(Baseline, 6th Treatment, 2 Month Follow-Up)
- Patient Satisfaction Scale at 2 month follow up only(Baseline, 6th Treatment, 2 Month Follow-Up)