Comparative Effects of Percussion Massage Therapy and Instrument-Assisted Soft Tissue Mobilization as Adjuncts to Conventional Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Shoulder Joint Position Sense Error
研究概览
简要总结
This assessor-blinded, three-arm, parallel-group randomized controlled trial will investigate the additional effects of percussion massage therapy and instrument-assisted soft tissue mobilization in individuals with subacromial impingement syndrome. Forty-eight participants aged 40-60 years with clinically and magnetic resonance imaging-confirmed subacromial impingement syndrome will be randomly allocated in a 1:1:1 ratio to conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy.
All groups received a standardized four-week conventional physiotherapy programme. Participants in the percussion massage therapy and instrument-assisted soft tissue mobilization groups additionally received their respective interventions three times per week for four weeks. Outcomes were evaluated at baseline and immediately after the four-week intervention. The primary outcome was shoulder joint position sense during flexion and abduction. Secondary outcomes were shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life.
详细描述
Subacromial impingement syndrome is commonly associated with shoulder pain, limitations in range of motion, functional disability, and impaired sensorimotor control. Exercise-based rehabilitation is considered a primary component of conservative management. Percussion massage therapy and instrument-assisted soft tissue mobilization are frequently used as adjunct soft-tissue interventions; however, comparative evidence regarding their additional effects in individuals with subacromial impingement syndrome remains limited.
This study will be conducted as a parallel-group, assessor-blinded randomized controlled trial with a 1:1:1 allocation ratio. Forty-eight eligible participants will be randomly allocated to one of three groups: conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy.
The randomization sequence will be computer-generated using Randomizer.org by an independent researcher who will not be involved in participant recruitment, intervention delivery, or outcome assessment. Because of the nature of the interventions, blinding of participants and treating physiotherapists will not be possible. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.
All participants will receive a standardized conventional physiotherapy programme for four weeks. Participants assigned to the percussion massage therapy and instrument-assisted soft tissue mobilization groups will additionally receive the corresponding soft-tissue intervention three times per week for four weeks.
Outcome assessments will be performed at baseline and immediately after completion of the four-week intervention. The primary outcome will be shoulder joint position sense during flexion and abduction. Secondary outcomes will include shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life.
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
Because of the nature of the interventions, participants and treating physiotherapists will be aware of the allocated intervention. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 40 to 60 years.
- •Diagnosis of subacromial impingement syndrome confirmed by clinical examination and -magnetic resonance imaging.
- •Positive Neer test.
- •Positive Hawkins-Kennedy test.
- •Positive painful arc test.
- •Shoulder symptoms persisting for at least one month.
- •Ability and willingness to participate in the assessment and intervention programme.
- •Provision of written informed consent.
排除标准
- •Previous surgery involving the affected upper extremity.
- •Inflammatory joint disease.
- •Shoulder osteoarthritis.
- •Rheumatic disease.
- •Malignant or benign tumour affecting the shoulder region or upper extremity.
- •Open wound or active infection in the shoulder region.
- •Inability to tolerate vibration-based therapy.
- •Inability to comply with the study protocol or intervention programme.
研究组 & 干预措施
IASTM Plus Conventional Physiotherapy
Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive instrument-assisted soft tissue mobilization three times per week for four weeks.
干预措施: Instrument-assisted soft tissue mobilization device (Device)
Percussion Massage Therapy Plus Conventional Physiotherapy
Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive percussion massage therapy three times per week for four weeks.
干预措施: Percussion massage therapy device (Device)
Percussion Massage Therapy Plus Conventional Physiotherapy
Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive percussion massage therapy three times per week for four weeks.
干预措施: Conventional Physiotherapy (Other)
IASTM Plus Conventional Physiotherapy
Participants will receive the standardized conventional physiotherapy programme for four weeks and will additionally receive instrument-assisted soft tissue mobilization three times per week for four weeks.
干预措施: Conventional Physiotherapy (Other)
Conventional Physiotherapy
Participants will receive a standardized, supervised conventional physiotherapy programme five sessions per week for four weeks.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change in Shoulder Joint Position Sense Error
时间窗: Baseline and immediately after the 4-week intervention
Shoulder joint position sense will be assessed using a digital goniometer at target positions of 60° of shoulder flexion and 60° of shoulder abduction. The affected shoulder will be passively positioned at the target angle, and the participant will be allowed up to 10 seconds to memorize the position. The arm will then be returned to the neutral position, and the participant will be asked to actively reproduce the target position with their eyes closed. The absolute angular difference between the target position and the reproduced position will be calculated in degrees. Three trials will be conducted for flexion and three trials for abduction, and the mean absolute error for each direction will be used in the analysis. Lower values will indicate greater joint position sense accuracy.
次要结局
- Change in Shoulder Range of Motion(Baseline and immediately after the 4-week intervention)
- Change in Resting and Activity-Related Shoulder Pain(Baseline and immediately after the 4-week intervention)
- Change in Upper-Extremity Disability(Baseline and immediately after the 4-week intervention)
- Change in Rotator Cuff-Related Quality of Life(Baseline and immediately after the 4-week intervention)
研究者
Emre DANSUK
Principal Investigator
Medipol University