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临床试验 NCT07260019 针对Upper Trapezius Trigger Points，Non Specific Chronic Neck Pain目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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开罗大学INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
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临床试验NCT07260019是一项针对Upper Trapezius Trigger Points，Non Specific Chronic Neck Pain的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年12月1日开始，预计招募75名患者。该研究由开罗大学主导，计划于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月2日。
简要概括
The goal of this randomized controlled trial is to compare the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and dry cupping in patients (both genders), aged 20-50 years, diagnosed with chronic non-specific neck pain who have active upper trapezius trigger points. The main questions it aims to answer are :
- Is there a significant difference in the effect on pain level (measured by VAS) between the groups?
- Is there a significant difference in the effect on cervical range of motion (CROM), pressure pain threshold (PPT), and functional disability (NDI) between the groups?
Researchers will compare three groups:
- Group A (Control):] Will receive a conventional physical therapy program (hot packs, TENS, and exercises).
- Group B (Experimental):] Will receive conventional therapy plus IASTM.
- Group C (Experimental):] Will receive conventional therapy plus Dry Cupping.
Participants will be asked to do the following:
- Undergo baseline assessments (measuring pain, ROM, PPT, and disability) before treatment and final assessments after 4 weeks.
- Attend [3 treatment sessions per week for four weeks].
- At each session, all participants will receive the conventional physical therapy program , while Groups B and C will receive their additional intervention (IASTM or dry cupping).
官方标题
INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
疾病
Upper Trapezius Trigger PointsNon Specific Chronic Neck Pain其他研究标识符
- P.T.REC/012/006052
NCT编号
实际开始日期
2025-12-01
最近更新发布
2025-12-02
预计完成日期
2026-12
计划入组人数
75
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
IASTM
DRY CUPPING
UPPER TRAPEZIUS TRIGGER POINTS
DRY CUPPING
UPPER TRAPEZIUS TRIGGER POINTS
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Group A (Control Group) Participants will receive a conventional physical therapy program. This includes hot packs applied over the neck and upper shoulders for 15-20 minutes , Transcutaneous Electrical Nerve Stimulation (TENS) applied for 20-30 minutes , and a supervised exercise program (including range of motion, isometric strengthening, chin tucks, and scapular retractions). The treatment will be administered for 3 sessions per week for four weeks. | Hot Packs Commercially accessible hot packs (made of bentonite) are placed over the neck and the upper part of the shoulder musculature while the patient is in a prone position. The application lasts for 15-20 minutes. 经皮电神经刺激 Applied while the patient is sitting. Electrodes are placed directly over or surrounding the trigger point and along the muscle belly. Parameters: Pulse rate 60-100Hz , Pulse width 40-250 μs. Intensity is set to a tolerable tingling sensation. Treatment duration is 20-30 minutes. 运动计划 A supervised home exercise program consisting of:
Range of Motion Exercises: Cervical flexion, extension, lateral flexion, rotation, and shoulder shrugs.
Strengthening Exercises: Isometric cervical flexion, extension, lateral flexion, and rotation; scapular retractions; and chin tucks.
Dosage: Performed daily for 10-15 repetitions and 2-3 sets |
实验性Group B (IASTM Group) Participants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Instrument Assisted Soft Tissue Mobilization (IASTM). This combined treatment will be administered for 3 sessions per week for four weeks. | 器械辅助软组织松动术 While the participant is seated, a lubricant (Vaseline) is applied to the skin. The M2T blade is used at a 45° angle to apply slow sweeping strokes along the muscle from origin to insertion (sweeping technique) over the upper trapezius for approximately three minutes. Hot Packs Commercially accessible hot packs (made of bentonite) are placed over the neck and the upper part of the shoulder musculature while the patient is in a prone position. The application lasts for 15-20 minutes. 经皮电神经刺激 Applied while the patient is sitting. Electrodes are placed directly over or surrounding the trigger point and along the muscle belly. Parameters: Pulse rate 60-100Hz , Pulse width 40-250 μs. Intensity is set to a tolerable tingling sensation. Treatment duration is 20-30 minutes. 运动计划 A supervised home exercise program consisting of:
Range of Motion Exercises: Cervical flexion, extension, lateral flexion, rotation, and shoulder shrugs.
Strengthening Exercises: Isometric cervical flexion, extension, lateral flexion, and rotation; scapular retractions; and chin tucks.
Dosage: Performed daily for 10-15 repetitions and 2-3 sets |
实验性Group C (Dry Cupping Group) Participants will receive the same conventional physical therapy program as Group A (hot packs, TENS, and exercises) . In addition, they will receive Dry Cupping. This combined treatment will be administered for 3 sessions per week for four weeks. | DRY Cupping While the participant is in a prone position , a single 5cm inner diameter plastic cup is applied to the skin directly over the pre-determined treatment location. The cup is secured by pumping a manual hand-pump three times. The cup is left in place for 5 minutes. Hot Packs Commercially accessible hot packs (made of bentonite) are placed over the neck and the upper part of the shoulder musculature while the patient is in a prone position. The application lasts for 15-20 minutes. 经皮电神经刺激 Applied while the patient is sitting. Electrodes are placed directly over or surrounding the trigger point and along the muscle belly. Parameters: Pulse rate 60-100Hz , Pulse width 40-250 μs. Intensity is set to a tolerable tingling sensation. Treatment duration is 20-30 minutes. 运动计划 A supervised home exercise program consisting of:
Range of Motion Exercises: Cervical flexion, extension, lateral flexion, rotation, and shoulder shrugs.
Strengthening Exercises: Isometric cervical flexion, extension, lateral flexion, and rotation; scapular retractions; and chin tucks.
Dosage: Performed daily for 10-15 repetitions and 2-3 sets |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pain Intensity Level | Pain intensity will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported 10 cm line where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain". | Baseline (before intervention) and after 4 weeks of treatment. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Cervical Range of Motion (CROM) | Active cervical range of motion will be measured in degrees using a Cervical Range of Motion (CROM) device. Measurements will be taken for flexion, extension, lateral flexion (right and left), and rotation (right and left) . Three trials will be averaged for each movement. | Baseline (before intervention) and after 4 weeks of treatment. |
Pressure Pain Threshold (PPT) | PPT will be assessed using a manual pressure algometer applied to the identified myofascial trigger point. Pressure will be increased at a rate of 1 kg/cm² per second until the patient first reports the sensation of pressure changing to pain. The average of three measurements, taken 30 seconds apart, will be recorded. | Baseline (before intervention) and after 4 weeks of treatment. |
Functional Disability | Functional disability will be assessed using the validated Arabic version of the Neck Disability Index (NDI-AR). This is a 10-item self-reported questionnaire that evaluates limitations in daily activities and functional impairment due to neck pain. | Baseline (before intervention) and after the 4-week intervention period. |
资格标准
适龄参与研究
成人
最低年龄要求
20 Years
适龄性别
全部
- Participants aged 20 to 50.
- Diagnosis of chronic non-specific neck pain (> 4 weeks duration).
- Had an active upper trapezius TrP (defined as a tender nodule in a taut band that referred pain in a pattern specific for upper trapezius TrP1 or TrP2).
- Pain of at least 40 mm on a visual analogue scale (VAS).
- Body mass index from 18 - 30 kg/m2
- Participants who will exhibit signs of fibromyalgia syndrome.
- Participants with a specific neck pain such as cervical radiculopathy with neurological deficits (e.g., motor weakness, significant sensory loss), cervical instability, fracture, tumor, infection, or inflammatory arthropathies.
- Sensory problems in the upper or midback regions, heart/circulation problems.
- Participants who will have vascular syndromes such as vertebrobasilar insufficiency.
- Participants with skin lesions, fragile skin, or a history of bleeding disorders.
研究责任方
Ibrahim Hassan Elsayed Mohamed Mady, 主要研究者, Principal Investigator, Cairo University
研究中心联系人
联系人: IBRAHIM H MADY, BSc, +201556822721, [email protected]
联系人: Fatma Seddik, Prof. Dr., +201223417697
没有位置数据。