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临床试验/NCT07078084
NCT07078084尚未招募不适用

Laterality Training and Pain Drawings: A Randomized Controlled Trial

Hawaii Pacific University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

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

Experimental

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

Sham 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))

研究者

发起方
Hawaii Pacific University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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