A Feasibility and Acceptability Study of a Physical Exercise Program Including Neural Mobilization to Improve Pain, Functional Status, and Physical Performance in Older Adults With Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dropout and adherence rates
研究概览
简要总结
The goal of this pilot study is to evaluate the feasibility of integrating neural mobilization techniques into a multimodal physical exercise program for older adults with chronic musculoskeletal pain. The main questions it aims to answer are:
- What is the average time to assess secondary outcomes for each participant?
- What proportion of participants adhered and/or withdrew from the study at the end of the intervention protocol?
- Are there adverse events/effects associated with the intervention protocol?
- What is the level of approval/satisfaction of the participants in relation to the assessment and intervention protocols?
- What is the impact of the intervention protocol on participants´ pain, function, physical performance, somatosensory function, and nerve excursion (secondary outcomes)?
Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (8 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program (with or without integration of neural mobilization techniques) to be carried out over a period of 8 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 (Participant)
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, with primary or secondary chronic musculoskeletal pain in any body site and able to walk independently
排除标准
- •Individuals with post-surgical pain as a result of surgery performed in the last 6 months;
- •Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, neurodegenerative diseases, 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.
结局指标
主要结局
Dropout and adherence rates
时间窗: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Proportion of participants who adhered and withdrew from the study at the end of the intervention protocol. "Adherence to treatment" will be considered if the participant attends at least 12 sessions (75% of the total scheduled sessions).
Adverse events and adverse effects
时间窗: T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Proportion of participants that reported adverse events and adverse effects during the intervention protocol.
Practicality
时间窗: T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
The average time taken to assess secondary outcomes for each participant.
Acceptability
时间窗: T1: 8 weeks (post-intervention assessment)
The degree to which participants approve of or are satisfied with the assessment and intervention protocols. Acceptability will be assessed qualitatively through focus groups, where a recorded interview (audio only) will be carried out by the study's main researcher, in order to assess the participants' perception of the study and the intervention protocol.
次要结局
- Lower Limb Strength(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Grip Strength(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Neuropathic pain components(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Fear of Movement(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Temporal characteristics of pain(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Symptoms of Central Sensitization(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Pressure Pain Threshold (Thenar region of the right hand; Right calcaneus; Region of greatest pain)(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Pain severity(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Pain Catastrophizing(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Cold and Warm Perception Threshold ((Thenar region of the right hand; Right calcaneus; Region of greatest pain)(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Agility and Dynamic Balance(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Nerve excursion (median and tibial nerves)(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
- Range of Motion (ankle dorsiflexion and wrist extension)(T0: baseline assessment; T1: 8 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment))
研究者
Frederico Mesquita Baptista
Principal Investigator
Aveiro University