Post-Needling Soreness Depending On The Needle Diameter On Dry Needling On The Most Hyperalgesic Area Of The Internal Gastrocnemius In Plantar Fasciitis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Post-needling soreness intensity
研究概览
简要总结
Mechanical hyperalgesia areas, also known as myofascial trigger points, are treated by manual therapy or invasive technics. Dry needling achieves an improvement of the symptomatology in 70% of the subjects, being the acute patients the most benefited. However, bruising, bleeding, pain during treatment or post-needling soreness. Plantar fasciitis is the most common cause of interior heel pain, affects approximately 10% of the general population and is one of the most benefited pathologies in the long term by the application of dry needling The gauge of the needle chosen for the treatment can influence post-needling soreness intensity and pressure pain threshold.
Objective To evaluate the relation between post-needling soreness intensity and needle diameter on the treatment of the most hyperalgesic point of the internal gastrocnemius.
Hypothesis Post-needling soreness intensity and pressure pain threshold depend on needle diameter applied in the treatment of the most hyperalgesic point of the internal gastrocnemius.
详细描述
Intervention:
Two zones are established:
- Zone 1: where researcher nº 1 controls the data management and sample randomization.
- Zone 2: where researcher nº 2 locates the most hyperalgesic area and measures pressure point threshold variable and researcher nº 3 performs dry needling puncture.
Researcher nº 1 explains to the subjects how the study works, collects the confidential documents and scores the independent variables (sex, age and BMI). Every subject receives an identification code and is randomly assign to a intervention group (A, B or C) Researcher nº 2 makes delivery of the document where the variables pressure pain threshold and post-needling soreness intensity will be written down. Firstly, the visual analogue scale compliance prior to the intervention is requested. After that, the subject is placed in prone position on the stretcher with a slight knee flexion and the most hyperalgesic area in the internal gastrocnemius of the lower limb with plantar fasciitis is located and marked.
Researcher nº 2 performs the algometry at the most hyperalgesic area (3 measurements with 30 seconds between them), writes down the results of pressure pain threshold variable and leaves the room.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plantar Fasciitis diagnosis.
- •Presence of hyperalgesic area in the internal gastrocnemius.
排除标准
- •Belenophobia
- •Hypothyroidism Presence of hyperalgesic area in the internal gastrocnemius - Diabetes
- •Lymphedema o lymphatic surgery Muscle diseases
- •Anticoagulant consumption Knee or ankle surgery
- •Analgesic consumption during the study
研究组 & 干预措施
Group A treated with a 16-gauge needle
Group A is intervened on the gastrocnemius muscle with a 16-gauge needle.
干预措施: Dry needling treatment with a thinner needle (Procedure)
Group B treated with a 25-gauge needle
Group B is intervened on the gastrocnemius muscle with a 25-gauge needle.
干预措施: Dry needling treatment with a medium-sized needle (Procedure)
Group C treated with a 32-gauge needle
Group C is intervened on the gastrocnemius muscle with a 32-gauge needle.
干预措施: Dry needling treatment with a thickest needle (Procedure)
结局指标
主要结局
Post-needling soreness intensity
时间窗: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Pressure Pain Threshold
时间窗: Change from Baseline Pressure Pain Threshold at 72 hours
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. A lower threshold is a worse result. A higher threshold is a better result.
次要结局
未报告次要终点
研究者
Prof. Dr. Daniel Pecos Martín
Dr. Daniel Pecos Martín
University of Alcala