Clinical Effects of Combined Therapy, Jones Technique, and Their Combination in Women With Upper Trapezius Myofascial Trigger Points: A Four-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
Myofascial trigger points in the upper trapezius muscle are a common cause of neck pain and may negatively affect pressure pain threshold, upper limb function, sleep quality, and quality of life. This randomized, sham-controlled clinical trial aimed to compare the effects of the Jones Technique, combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]), their combination, and a sham intervention in women with active upper trapezius myofascial trigger points. The primary outcome was pressure pain threshold. Secondary outcomes included pain intensity, upper limb disability, sleep quality, quality of life, physical activity level, and participant satisfaction.
详细描述
Myofascial trigger points (MTrPs) in the upper trapezius muscle are frequently associated with neck pain, reduced pressure pain threshold, and impaired upper limb function. Several conservative interventions have been proposed for the treatment of MTrPs; however, evidence comparing manual therapy and combined electrotherapy remains limited.
This single-center, randomized, sham-controlled, parallel-group clinical trial evaluated the effects of the Jones Technique and combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) in women aged 18 to 40 years presenting with active myofascial trigger points in the upper trapezius muscle.
Participants were randomly allocated (1:1:1:1) into four groups: (1) Jones Technique; (2) combined therapy; (3) combined therapy plus Jones Technique; and (4) sham control. Randomization was performed using block randomization stratified by age. Participants underwent a single treatment session.
Baseline assessments included demographic data, pain intensity measured using the Visual Analog Scale (VAS), pressure pain threshold measured with a pressure algometer, upper limb disability (DASH), sleep quality (Pittsburgh Sleep Quality Index), quality of life (SF-36), and physical activity level (IPAQ). Immediately after the intervention, pain intensity, pressure pain threshold, and participant satisfaction were reassessed.
The primary outcome was pressure pain threshold. Secondary outcomes included pain intensity, upper limb disability, sleep quality, quality of life, physical activity level, and participant satisfaction.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 18 to 40 years.
- •Presence of active myofascial trigger points in the upper trapezius muscle for no longer than 12 weeks.
- •Neck pain lasting less than 3 months.
- •Pain intensity of at least 3 cm on the 10-cm Visual Analog Scale (VAS).
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Presence of a cardiac pacemaker or other contraindications to electrotherapy.
- •Pregnancy.
- •Uncontrolled cardiovascular disease.
- •Psychiatric disorders that could interfere with study participation.
- •Thrombosis or coagulation disorders.
- •History of tumors or neoplasms.
- •Physical therapy or myofascial treatment within the previous 3 weeks.
- •Treatment for myofascial trigger points within the previous 3 months.
- •Current use of analgesic medications.
- •Cervical musculoskeletal disorders (e.g., cervical osteoarthritis or other cervical lesions).
- •History of cervical trauma or surgery.
- •Cervical spondylosis or spondylolisthesis with radiculopathy.
- •Fibromyalgia or other systemic rheumatic diseases.
- •Other musculoskeletal disorders that could interfere with the study outcomes.
研究组 & 干预措施
Jones Technique
Participants received a single session of the Jones Technique for the treatment of active myofascial trigger points in the upper trapezius muscle.
干预措施: Jones Technique (Procedure)
Combined Therapy
Participants received a single session of combined therapy consisting of therapeutic ultrasound combined with transcutaneous electrical nerve stimulation (TENS) applied to active myofascial trigger points in the upper trapezius muscle.
干预措施: Combined Therapy (Therapeutic Ultrasound + TENS) (Device)
Combined Therapy + Jones Technique
Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) during a single treatment session.
干预措施: Combined Therapy + Jones Technique (Combination Product)
Sham Control
Participants underwent all study assessments and received sham treatment consisting of inactive combined therapy (device turned off) and a simulated Jones Technique without therapeutic pressure.
干预措施: Sham Intervention (Procedure)
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: Baseline and immediately after the intervention (single treatment session)
Pressure pain threshold assessed using a pressure algometer at five active myofascial trigger points in the upper trapezius muscle. The pressure pain threshold is recorded in kg/cm². Higher values indicate greater pressure tolerance and therefore a better outcome.
Pain Intensity
时间窗: Baseline and immediately after the intervention
Pain intensity assessed using the Visual Analog Scale for Pain (VAS). Scores range from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
次要结局
- Upper Limb Disability(Baseline)
- Sleep Quality(Baseline)
- Quality of life(Baseline)
- Physical Activity Level(Baseline)
- Participant Satisfaction(Immediately after the intervention)
研究者
Isabel de Almeida Paz
Principal Investigator
University of the Sinos Valley