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临床试验/NCT04717167
NCT04717167已完成不适用

The Effect of One Dry Needling Session on Pain and Central Pain Processing in Patients With Knee Osteoarthritis: a Randomized Controlled Trial

Universiteit Antwerpen0 个研究点目标入组 61 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
主要终点
Pain pressure thresholds

研究概览

简要总结

Research suggests that myofascial trigger points (MTrP) play an important role in explaining pain in patients with musculoskeletal knee disorders. Trigger points are usually defined as hypersensitive tender spots within taut bands of skeletal muscles that are painful on muscle stimulation and that usually elicit referred pain. Treatment of these trigger points could possibly alleviate symptoms in patients with knee pain. However, literature on the effect of trigger point therapy, dry needling in particular, in patients with musculoskeletal knee disorders is scarce. The purpose of this study is to examine the effect of trigger point therapy (dry needling (DN)) on pain, presence of altered central pain processing, muscle features and gait pattern in patients with knee osteoarthritis (KOA). 60 patients with symptomatic KOA will participate in this study. They will randomly be allocated in either an experimental group (EG) (dry needling technique) or a placebo group (PG) (sham needling technique). Pain (Visual analogue scale (VAS) & KOA outcome score (KOOS), muscle features during gait and gait pattern (3D gait analysis and surface electroMyoGraphy (EMG)) and presence of altered central pain processing (Central Sensitization Inventory (CSI), Quantitative Sensory testing (QST)) will be measured at baseline and 15 minutes after the intervention. Additionally, pain will be measured 3 days after the intervention. The investigators hypothesize that the effect on the outcome measures will be significantly larger in the EG compared to the PG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

A double-blinded study was achieved by giving no information about the assigned intervention to the executive researchers; and only the same general explanation about the intervention type to the subjects (Appendix A). Moreover, subjects were prohibited to see the needling-intervention. The group allocation was solely known by the treating therapists and the independent researcher (IB).

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A minimum age of fifty years old;
  • Diagnosed with KOA based on the American College of Rheumatology (ACR) clinical classification criteria(48), including:
  • A Kellgren-Lawrence grade of minimum two on radiography;
  • At least three months of chronical knee pain.

排除标准

  • Patients suffering from autoimmune and/or neurological disorders
  • Patients who had a major trauma/fracture of the lower limb in the past six months -
  • Patients who experienced other musculoskeletal problems than OA

结局指标

主要结局

Pain pressure thresholds

时间窗: Change from baseline central pain processing at 15minutes postintervention

Measured with an digital algometer (kilogram force/ square cm)

Conditioned pain modulation

时间窗: Change from baseline central pain processing at 15minutes postintervention

Measured with an digital algometer (test stimulus) and an inflatable cuff (conditioning stimulus). (kilogram force/ square cm)

Temporal summation

时间窗: Change from baseline central pain processing at 15minutes postintervention

Measured with an digital algometer (kilogram force/ square cm)

Pain sensation

时间窗: Change from 15minutes postintervention pain sensation at 3days postintervention

Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.

次要结局

  • Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris(Change from baseline muscle coactivation at 15minutes postintervention)
  • Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis(Change from baseline muscle coactivation at 15minutes postintervention)
  • Step time (meters/second)(Change from baseline muscle coactivation at 15minutes postintervention)
  • Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus(Change from baseline muscle coactivation at 15minutes postintervention)
  • Step width (meters)(Change from baseline muscle coactivation at 15minutes postintervention)
  • Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus(Change from baseline muscle coactivation at 15minutes postintervention)
  • Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris(Change from baseline muscle coactivation at 15minutes postintervention)
  • Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis(Change from baseline muscle coactivation at 15minutes postintervention)
  • Stride time (seconds)(Change from baseline muscle coactivation at 15minutes postintervention)
  • Stride length (meters)(Change from baseline muscle coactivation at 15minutes postintervention)
  • Step length (meters)(Change from baseline muscle coactivation at 15minutes postintervention)
  • Stance phase (%)(Change from baseline muscle coactivation at 15minutes postintervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sophie Vervullens

Doctoral Candidate

Universiteit Antwerpen

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