A Comparative Study of Two Different Physical Exercise Programs to Improve Pain, Functional Status, and Physical Performance in Older Adults With Chronic Musculoskeletal Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain Severity
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of a multimodal physical exercise program for older adults (> 60 years) with chronic musculoskeletal pain. The main question it aims to answer is:
What is the impact of the intervention program on participants´ pain intensity (primary outcome), function, physical performance, and somatosensory function (secondary outcomes)? Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (10 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program to be carried out over a period of 10 weeks at a frequency of twice a week.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling older adults aged 60 years or older
- •People with primary or secondary chronic musculoskeletal pain in any body site
- •People able to walk independently
排除标准
- •Individuals undergoing surgery in the last 3 months
- •Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, stroke, uncontrolled diabetes, or at high risk of developing cardiovascular events
- •Those with physical limitations that make it impossible for them to carry out the intervention protocols independently (e.g., wheelchair user)
- •Patients who are receiving another physical therapy intervention to treat their pain.
研究组 & 干预措施
Physical exercise
干预措施: Physical exercise program (Other)
Physical exercise + Neural mobilization
干预措施: Physical exercise program (Other)
Physical exercise + Neural mobilization
干预措施: Neural mobilization techniques (Other)
结局指标
主要结局
Pain Severity
时间窗: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Brief Pain Inventory - It assesses pain intensity and functional interference related to pain in the last week. In addition to these two main aspects, it also evaluates the location of the pain, the use of medications and the amount of pain relief in the last week. The instrument has 4 items relating to pain intensity in the last week and 7 items relating to the functional interference of pain with numerical rating scales (from 0 to 10) where higher values indicate greater pain severity. In situations where the participant reports musculoskeletal pain in more than one site, they will be asked to answer the questions considering their main chronic pain.
次要结局
- Temporal characteristics of pain(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Neuropathic pain components(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Pain Catastrophizing(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Fear of Movement(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Signs and symptoms of hypersensitivity of the nervous system(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Pressure Pain Threshold measured in three different sites (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Q-sense - Cold and Warm Perception Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Q-sense - Heat Pain Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Lower Limb Strength(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Grip Strength(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Balance(T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
研究者
Frederico Mesquita Baptista
Principal Investigator
Aveiro University