INSTRUMENT ASSISSTED SOFT TISSUE MOBILIZATION VERSUS DRY CUPPING ON UPPER TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Pain Intensity Level
研究概览
简要总结
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).
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 (Outcomes Assessor)
盲法说明
The study is described as a "single blinded randomized controlled trial". Given the distinct physical nature of the interventions (IASTM vs. Dry Cupping), it is not feasible to blind the participants or the care providers. Blinding will be applied to the Outcomes Assessor, who will perform the outcome measurements without knowledge of the participant's group assignment to prevent bias.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 20 to
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hot Packs (Other)
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.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
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.
干预措施: Exercise Program (Behavioral)
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.
干预措施: Instrument Assisted Soft Tissue Mobilization (Device)
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.
干预措施: Hot Packs (Other)
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.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
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.
干预措施: Exercise Program (Behavioral)
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.
干预措施: Dry Cupping (Device)
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.
干预措施: Hot Packs (Other)
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.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
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.
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Pain Intensity Level
时间窗: Baseline (before intervention) and after 4 weeks of treatment.
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".
次要结局
- Cervical Range of Motion (CROM)(Baseline (before intervention) and after 4 weeks of treatment.)
- Functional Disability(Baseline (before intervention) and after the 4-week intervention period.)
- Pressure Pain Threshold (PPT)(Baseline (before intervention) and after 4 weeks of treatment.)
研究者
Ibrahim Hassan Elsayed Mohamed Mady
Principal Investigator
Cairo University