Laterality Training and Pain Drawings: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Pain Drawing Area
研究概览
简要总结
The goal of this clinical trial is to learn if laterality training (a type of brain-based therapy) can help reduce pain and change how people with chronic musculoskeletal pain experience and describe their pain. The study will focus on adults with shoulder or knee pain lasting longer than 6 months.
The main questions it aims to answer are:
Does laterality training lead to a reduction in self-reported pain levels?
Does laterality training reduce the area of the body that participants indicate as painful in their pain drawings?
Does laterality training improve accuracy and speed in left/right judgment tasks?
Researchers will compare participants who complete laterality training to those who complete a non-therapeutic cognitive task (a word puzzle) to see if laterality training changes pain drawings and improves pain outcomes.
Participants will:
Complete a pre-intervention assessment including pain ratings, pain drawings, and a left/right judgment test
Be randomly assigned to one of two groups:
Intervention group: Complete 5 one-minute sessions of laterality training using a tablet-based app called Recognise™, identifying left or right hand/foot images depending on the location of their pain
Control group: Complete a 10-minute crossword puzzle activity (non-therapeutic)
Complete the same assessments after the activity (pain ratings, pain drawings, left/right judgment test)
The study will take place at two outpatient physical therapy clinics. Participation involves a single session lasting approximately 30-45 minutes. There is no cost to participate, and no compensation is provided. Participation is voluntary, and all personal data will be kept confidential.
This research will help determine whether laterality training, a non-invasive brain-based technique, can reduce pain and improve quality of life in people with long-standing musculoskeletal pain.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosis of chronic shoulder or knee pain lasting more than 6 months
- •Able to read and understand English
- •Willing to provide written informed consent
排除标准
- •Visual impairments that would interfere with laterality training (e.g., blindness or significant difficulty with vision)
- •Previous participation in laterality (left/right discrimination) training
- •Unwilling or unable to participate in the study procedures
研究组 & 干预措施
Laterality Training Intervention
Participants in this arm will complete laterality training using the Recognise™ application. This involves identifying left or right hand or foot images (depending on the participant's pain location) displayed on a tablet. Each participant will complete 5 rounds of 60-second training with 60-second rest intervals between rounds. The activity is designed to engage cortical body maps and promote neuroplastic changes associated with reduced pain perception.
干预措施: Laterality Training (Behavioral)
Sham Cognitive Task Comparator
Participants in this arm will complete a non-therapeutic cognitive activity by working independently on a standard word-based crossword puzzle for 10 minutes. This task is designed to match the duration and engagement level of the laterality training without influencing sensorimotor processing or cortical body maps. It serves as a sham comparator to help isolate the specific effects of the laterality training intervention
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Change in Pain Drawing Area
时间窗: Baseline and post-intervention (approximately 15 minutes after Baseline)
Measured using a standardized body chart with a grid overlay. Participants mark areas of perceived pain, and the total number of grid squares marked is quantified to assess changes in spatial pain representation.
次要结局
- Change in Left/Right Judgment Accuracy and Reaction Time(Baseline and post-intervention (approximately 15 minutes after Baseline))
- Change in Numeric Pain Rating Scale (NPRS)(Baseline and post-intervention (approximately 15 minutes after Baseline))
