The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment: an Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle.
The specific objective of the study is to observe the interaction between patient expectations and hypoalgesic effects in patients who will receive the same technique but with different explanations about it before punction and which could influence on the modulation of post-punction pain.
详细描述
Study design:
A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial was conducted, where both the study subject and the researcher performing the measurements do not know which treatment group they belong to.
Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were recruited personally for the study. All of them will have 15 incisions by dry needling in latent trigger point of the upper trapezium localized by palpation. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand. Patients were randomly assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups.
Each group will be given a different sentence: one group will be attempted to influence with positive expectation, another with neutral expectation, and yet another will be attempted to influence with negative expectation.
Measurement instruments
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
- Double (Participant, Outcomes Assessor)
盲法说明
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced:
- Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature"
- Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects"
- Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".
Neither the subjects assigned to the groups nor the researchers who measured the variables knew which group they belonged to.
Patients will be randomly assigned through GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups.
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 18 and X years of age.
- •Presence of at least one latent myofascial trigger point in the upper trapezius muscle.
- •Patients who speak and understand Spanish correctly.
- •Subjects without previous experience in dry puncture treatment.
排除标准
- •If patients had neurological signs and symptoms.
- •Subjects with a history of trauma, fracture or previous spinal surgery.
- •Subjects with a history of musculoskeletal and/or rheumatological diseases.
- •Unsurpassed fear of needles
- •Coagulation disorders
- •Infiltration of corticosteroids or local anesthetics for one year prior to the study.
- •Taking analgesic or anti-inflammatory medication the week before the study.
研究组 & 干预措施
Placebo Effect
Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature"
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
干预措施: Dry Needling (Other)
Nocebo Effect
Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
干预措施: Dry Needling (Other)
Neutral Effect
Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects"
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced.
干预措施: Dry Needling (Other)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.
次要结局
- TSK (Tampa Scale for Kinesiophobia)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- STAI (State-Trait Anxiety)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- Neck Disability Index(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- FPQ-III (Fear of Pain Questionnaire)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- PASS-20 (Pain Anxiety Symptoms Scale)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- Beck II (Depression)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
- PCS (Pain Catastrophizing Scale)(Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling)
研究者
Eleuterio Atanasio Sánchez Romero
Professor Orofacial Pain AND Craniomandibular Disorders / Invasive Techniques in Physical Therapy / Orthopedic Manual Physical Therapist ( PT, MSc, PhD) International Doctorate
Universidad Europea de Madrid