Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: 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
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12.
研究概览
简要总结
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder.
The main questions this study aims to answer are:
Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction?
Researchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder.
Participants will:
Receive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy.
Attend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.
详细描述
This is a randomized, double-blind (participants and outcome assessors), sham-controlled study. Participants will be recruited from a university hospital. Volunteers diagnosed with frozen shoulder who meet the inclusion criteria and are referred by an orthopedics and traumatology specialist will be included.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Participants who provide written informed consent and meet the inclusion criteria will be randomized in a 1:1 ratio to either exercise therapy combined with active transcutaneous Vagus Nerve Stimulation (tVNS) or exercise therapy combined with sham-controlled tVNS.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years.
- •Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).
- •More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.
- •Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.
- •Shoulder pain lasting at least 3 months during activities of daily living.
排除标准
- •Passive joint range of motion within normal limits
- •External rotation range of motion <30°
- •Radiographic evidence of glenohumeral arthritis
- •Presence of inflammatory joint disease
- •Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)
- •Pain intensity <3 according to the Numerical Pain Rating Scale (NPRS)
- •Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy
研究组 & 干预措施
transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises
the interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises.
干预措施: Active tVNS plus exercises (Other)
Sham controlled tVNS plus exercises
the control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises.
干预措施: Sham controlled tVNS plus exercises (Other)
结局指标
主要结局
Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12.
时间窗: Change from baseline in SPADI score at weeks 6 and 12
The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability levels in patients. SPADI consists of 13 items and includes two subscales: pain and disability. The pain subscale consists of 5 items while the disability subscale consists of 8 items. Both subscale scores and the total score are calculated on a 0-100 scale, with higher scores indicating greater pain and disability.
Change from baseline of Numerical Rating Pain Scale (NPRS) at week 6 and week 12
时间窗: Change from baseline in NPRS score at week 6 and week 12
Pain intensity will be assessed using the Numerical Rating Pain Scale (NPRS). Participants will be asked to rate the intensity of their shoulder pain on a scale from 0 to 10, with higher scores indicating greater pain.
次要结局
- Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12(Change from baseline in QuickDASH score at weeks 6 and 12)
- Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12(Change from baseline in PCS score at weeks 6 and 12)
- change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12(Change from baseline in range of motion at weeks 6 and 12)
- Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12(Change from baseline in PSEQ score at weeks 6 and 12)
- Treatment satisfaction assessed with the Global Rating of Change (GRC) Scale at weeks 6 and 12(At weeks 6 and 12)
研究者
Salam Alruz
Principal Investigator
Istanbul University - Cerrahpasa