Comparison of the Effectivenes of Combined Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome in Upper Trapezius Muscle
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NRS)
研究概览
简要总结
This study was designed to compare the effectiveness of three different treatment protocols in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. A total of 90 volunteers aged between 18 and 65 years, with active trigger points identified in the upper trapezius muscle, will be included in the study. Participants will be randomly assigned to three groups:
- Group 1: Dry needling and stretching exercises
- Group 2: Dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
- Group 3 (Control): Sham dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
In all groups, treatment sessions will be administered at weeks 0, 1, 2, and 3; and participants will undergo clinical assessments at baseline (pre-treatment), at the end of treatment, one month after treatment completion, and three months after treatment completion. The primary outcome will be pain severity, measured using the Numeric Pain Rating Scale (NRS); secondary outcomes will include functional status evaluated with the Neck Pain and Disability Scale (NPADS) and QuickDASH, and muscle tenderness assessed by pressure pain threshold (PPT) measurement. The findings are expected to contribute scientifically to clinical practice by identifying the most effective treatment combination for managing upper trapezius myofascial pain syndrome.
详细描述
Myofascial pain syndrome (MPS) is one of the most common causes of chronic pain among musculoskeletal disorders, leading to both individual workforce loss and a decrease in quality of life. The pathophysiological basis of MPS consists of hyperalgesic areas within the muscle tissue, known as "trigger points. These trigger points usually arise due to repetitive microtrauma, poor posture, or static muscle use, with the upper trapezius muscle being one of the most frequently affected muscle groups .
Dry needling (DN) induces local microtrauma within the muscle by directly and invasively stimulating the trigger points, thereby initiating local inflammation and achieving an analgesic effect. DN is thought to work by reducing muscle spasm, increasing oxygenation, and providing segmental pain inhibition \[1, 5]. On the other hand, local anesthetic injection (LAI), particularly with agents such as lidocaine, provides rapid analgesia by temporarily blocking nerve conduction when applied directly around the trigger point .
Although the combined use of DN and LAI has gained attention in recent years, comparative clinical data regarding their efficacy remain limited. Some studies in the literature have shown that LAI is more effective than DN in reducing pain , yet systematic data on the advantages of combined protocols are insufficient. Additionally, some randomized controlled trials have reported that DN provides functional improvement, while achieving similar pain scores compared to LAI.
The use of sham procedures is critically important for evaluating the true biological effect of treatment. Especially in invasive techniques like dry needling, the absence of placebo control increases the risk of misinterpreting the analgesic effect. Therefore, there is a need for methodologically robust study designs.
The present study aims to demonstrate the clinical superiority of combining DN with LAI, compared to DN alone and sham groups, in terms of both pain reduction and functional improvement. The combined approach may result in more lasting outcomes on muscle tension and function. Moreover, thanks to the comparison group with sham procedures, the true clinical efficacy of the interventions can be evaluated more objectively.
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)
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
- •Being between 18 and 65 years of age
- •Having a diagnosis of myofascial pain syndrome with at least one active trigger point in the upper trapezius muscle according to the criteria of Travell and Simons
- •Having signed the informed consent form regarding the study
- •Having a history of muscle pain with VAS >3 persisting for at least four weeks in the same area (upper trapezius muscle)
排除标准
- •Having a diagnosis of cervical disc herniation, cervical radiculopathy, or myelopathy
- •A history of central or peripheral nervous system disease (e.g., multiple sclerosis, stroke, peripheral neuropathy)
- •Diagnosis of a major psychiatric disorder (major depression, anxiety disorder, bipolar disorder, schizophrenia) or receiving active psychiatric treatment
- •Having bleeding diathesis, thrombocytopenia, or using anticoagulant/antiplatelet therapy for any reason (e.g., warfarin, clopidogrel)
- •Presence of local infection at the injection site, dermatological lesions disrupting skin integrity, or signs of systemic infection
- •Being pregnant or breastfeeding
- •Having undergone injection, prolotherapy, or similar interventional treatment in the upper trapezius region within the last 6 months
- •Having received dry needling treatment in any region previously
- •A history of orthopedic or neurosurgical surgery involving the cervical spine, shoulder, or upper trapezius muscle region within the last year
- •Having a diagnosis of uncontrolled diabetes mellitus or advanced-stage chronic disease (e.g., congestive heart failure, renal failure)
- •Having a diagnosis of malignancy or systemic rheumatologic disease (e.g., rheumatoid arthritis, fibromyalgia syndrome, lupus)
- •Having communication difficulties, cognitive impairment, or severe visual/hearing loss that could prevent participation in the study
- •Having social/logistical barriers (e.g., transportation difficulties) that would prevent regular participation in the study process
研究组 & 干预措施
Local Anesthetic Injection + Sham Dry Needling Group
Patients will recieve %1 Lidocaine injection to the upper trapezius muscles trigger points. They will also recieve a sham dry needling, where the needle will not penetrate to the skin but the tube of the needle will be contacted to the skin.
干预措施: Sham Dry Needling (Procedure)
Local Anesthetic Injection + Sham Dry Needling Group
Patients will recieve %1 Lidocaine injection to the upper trapezius muscles trigger points. They will also recieve a sham dry needling, where the needle will not penetrate to the skin but the tube of the needle will be contacted to the skin.
干预措施: Local Anesthehetic Injection (Procedure)
Dry Needling Group
This group will get 3 sessions of dry needling to the trigger points on upper trapezius muscle.
干预措施: Dry Needling (Procedure)
Local Aensthetic injection + Dry Needling Group
This group will get trigger point local anesthetic injection and 3 sessions of dry needling terapy to the trigger points on upper trapezius muscle
干预措施: Dry Needling (Procedure)
Local Aensthetic injection + Dry Needling Group
This group will get trigger point local anesthetic injection and 3 sessions of dry needling terapy to the trigger points on upper trapezius muscle
干预措施: Local Anesthehetic Injection (Procedure)
结局指标
主要结局
Numeric Pain Rating Scale (NRS)
时间窗: It is the change from the baseline (pre-treatment) NRS (Numeric Pain Rating Scale) score to the NRS score at the 3rd month.
Numeric Pain Rating Scale (NRS): Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (the most severe pain) based on their own perception; the measurement will be conducted verbally by a qualified researcher in a calm environment
次要结局
- Neck Pain and Disability Scale (NPADS(3 months)
- QuickDASH(3 months)
- Pressure Pain Threshold (PPT)(3 months)
研究者
Emre Ata, Assoc Prof
Associate Professor, MD
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey