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临床试验/NCT03949998
NCT03949998撤回不适用

The Immediate Effects of Dry Needling on Post-concussion Syndrome

University of Guelph6 个研究点 分布在 1 个国家开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
6
主要终点
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention

研究概览

简要总结

In about 15% of adult concussion cases, symptoms last longer than 2 weeks and can largely impact the individual's ability to work, be physically active and participate in everyday life. These symptoms are often partially related to unresolved neck muscle tightness and other neck-related symptoms. Dry needling is a technique that uses acupuncture needles to release muscle knots, decrease neck muscle tightness and decrease neck pain. As far as the investigators are aware, there have been no studies looking at the effects of dry needling on symptoms of chronic concussion. This study will compare the effects of dry needling to traditional hands-on physiotherapy treatment of the neck for concussion-related symptoms. Participants with chronic concussion symptoms will receive either dry needling, hands-on manual physiotherapy or both. Concussion symptoms, symptom severity, neck range of motion and pain with pressure over neck muscles will be compared before and after treatment, and the day after treatment. The investigators expect that the greatest improvement in all of these will be seen in the group receiving both interventions, both immediately after treatment and the following day. If dry needling can immediately improve concussion symptoms, patients may better tolerate therapeutic exercise and experience quicker resolution of chronic symptoms.

详细描述

All participants will be tested in clinic once, for approximately a half hour. For all groups, outcome measures relating to concussion symptoms, cervical range of motion and pain pressure thresholds will be taken prior to and after the intervention.

In the DN group, four muscles (upper fibres trapezius, cervical multifidus, levator scapulae and suboccipitals) will be palpated by a physiotherapist trained in dry needling. If a palpable trigger point is found, the physiotherapist will perform dry needling until a local twitch response is elicited. If a trigger point is not found, no dry needling will take place. In this way, up to 8 total muscles will be needled during the session. The participant will be in prone for the above procedure.

In the MT group, soft tissue release will be performed on the above four muscles bilaterally. Cervical traction (unilateral grade 3 oscillatory distraction technique, any cervical segment between C0/C1 and C7/C7, 3-5 sets of 30 seconds) and mobilization (unilateral inferior-medial-posterior or superior-anterior-lateral, grade 3 oscillatory, any cervical segment between C0/C1 and C7/C7, 3-5 sets of 30 seconds ) will also be performed if the physiotherapist deems it necessary, specific to the spinal level noted to be involved. In the DN+MT group, MT interventions will be performed first, followed by DN, of the four above muscles. Immediately following intervention, the outcome measures will all be re-tested. The participants will also be instructed to fill out the SCAT-5 Step 2 upon waking the next morning. Additionally, if one or more of the cervical motions caused pain during initial testing, they will be asked to repeat the motion and report the current level of pain on the VAS scale.

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
None

入排标准

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

入选标准

  • experiencing concussion symptoms at least 4 weeks following an external impact injury to the head

排除标准

  • medical diagnoses of depression and/or anxiety
  • skull fractures
  • subdural or epidural haematomas
  • parenchymal bleeds
  • recent infection
  • vascular anomaly
  • hypertension
  • current or past smoker
  • high cholesterol
  • family history of stroke
  • malignant/inflammatory disease
  • osteoporosis
  • bleeding disorde
  • damaged heart valves
  • pacemaker or other electrical implants
  • fear of needles

结局指标

主要结局

Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention

时间窗: within 10 minutes of intervention

Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are either present (scored 1) or absent (scored 0), minimum = 0 (good outcome), maximum = 22 (poor outcome)

Change in baseline Cervical Range of Motion, immediately after intervention

时间窗: within 10 minutes of intervention

Cervical Active Range in flexion, extension, bilateral side flexion, bilateral rotation, measured in degrees using a CROM (Cervical Range of Motion) tool that measures multidirectional movement, each of the 6 ranges will be reported on their own in degrees and the 6 will also be added together for a total range measurement in degrees

Change in baseline pain score with Cervical Range of Motion, 12-24 hours after intervention

时间窗: 12-24 hours after intervention

Pain Rating Scale at end of range flexion, extension, bilateral side flexion, bilateral rotation (as measured in Outcome 5), scored 0 (no pain) - 10 (worst pain imaginable), 0 = best outcome, 10 = worst outcome, total score for all 6 movements will be computed out of 60 (0=best, 60=worst)

Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, 12-24 hours after intervention

时间窗: 12-24 hours after intervention

Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are either present (scored 1) or absent (scored 0), minimum = 0 (good outcome), maximum = 22 (poor outcome)

Change in baseline pain score with Cervical Range of Motion, immediately after intervention

时间窗: within 10 minutes of intervention

Pain Rating Scale at end of range flexion, extension, bilateral side flexion, bilateral rotation (as measured in Outcome 5), scored 0 (no pain) - 10 (worst pain imaginable), 0 = best outcome, 10 = worst outcome, total score for all 6 movements will be computed out of 60 (0=best, 60=worst)

Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, 12-24 hours after intervention

时间窗: 12-24 hours after intervention

Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are scored from 0 (absent) to 6 (worst imaginable), minimum = 0 (good outcome), maximum = 132 (poor outcome)

Change in baseline of Pain Pressure Threshold (the smallest amount of pressure that evokes pain) as measured using a pressure algometer, immediately after baseline

时间窗: within 10 minutes of intervention

The pressure algometer is applied to the test muscle (in this case bilateral upper fibres trapezius, levator scapulae, suboccipital group and cervical multifidus at the base of the neck) and pressure is applied incrementally until pain is reported, the outcome is the least amount of pressure (in kilograms) applied over a muscle that evokes pain (lowest = 0 kg, higher values are better outcomes)

Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, immediately after intervention

时间窗: within 10 minutes of intervention

Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are scored from 0 (absent) to 6 (worst imaginable), minimum = 0 (good outcome), maximum = 132 (poor outcome)

次要结局

未报告次要终点

研究者

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

Dr. Margo Mountjoy

Adjunct Professor

University of Guelph

研究点 (6)

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