Study of the Effect of Adding Manual Therapy to Therapeutic Exercise Programs in Older Adults With Limited Mobility and Pain Secondary to Aging.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 主要终点
- Change of the qualitative aspects of pain
研究概览
简要总结
This research project is part of the process of generating scientific evidence, on whether the clinical results obtained, in the treatment of the consequences of aging on mobility, pain and disability, are better if therapeutic exercise programs are added sessions of manual therapy and training in pain awareness, or on the contrary, do not significantly modify the effect of exercise programs.
详细描述
General objective:
Find out if adding Manual Therapy (MT) sessions to therapeutic exercise programs increases the efficacy of clinical results for the treatment of ailments derived from aging in older adults (65 <age <85).
Specific objectives:
- Assess the effects on pain. (hypothesis: MT improves pain outcomes)
- Assess the effects on physical disability. (hypothesis: MT improves results regarding physical disability)
- Assess the effects on mental disability. (hypothesis: MT improves results regarding mental disability)
- Assess the effects on the prevention of falls (hypothesis: MT improves the results regarding the risk of falls)
Methodology:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A triple blinding will be carried out: 1) of the patient, 2) of the collaborator who performs the data collection, 3) of the computer data analyst.
The physiotherapist who performs the intervention of manual therapy, exercise teaching and pain education, it is impossible to blind him.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People of both sexes.
- •Between 65 and 85 years of age.
- •No acute pathologies at the time of selection.
- •Who present symptoms of muscle-joint degenerative mechanical aging with an intensity score greater than 4 on a scale of 0-10.
排除标准
- •Patients with a recent traumatic history.
- •Presence of an acute-type radiation component of neurological origin to upper or lower limbs.
- •With neurological alterations both central and peripheral.
- •Who are taking opioid-based analgesic medication, gabapentin, etc.
- •Patients with severe malformations.
- •Who are following any other type of treatment, be it manual or physical agents or alternative or complementary therapies.
- •Those who have been treated with infiltrations or the like in a period of less than a year before starting the study.
- •Patients with a serious psychiatric history such as schizophrenia or psychopathies.
- •Patients with cognitive impairment.
- •Patients with vestibular problems that cannot tolerate oscillatory movements.
- •Those who are contraindicated due to their general metabolic or cardiopulmonary state to carry out moderate physical exercise.
研究组 & 干预措施
Exercise
to which the treatment of therapeutic exercise and pain education will be applied,
干预措施: Exercise (Other)
Manual Therapy
to which the same treatment as the control group will be applied, adding manual therapy sessions based on musculoskeletal rhythmic mobilizations.
干预措施: Manual Therapy (Other)
结局指标
主要结局
Change of the qualitative aspects of pain
时间窗: beginning and through study completion, an average of 12 weeks
using the McGill pain questionnary
Change of of disability and health status
时间窗: beginning and through study completion, an average of 12 weeks
using the SF36 test (36-item short form health survey)
Change of subjective assessment of pain intensity
时间窗: beginning and through study completion, an average of 12 weeks
using a VAS TEST (Visual Analog Score for pain) (Minimum = 0 better and maximum = 10 worse)
次要结局
- Change of Physical activity in older adults(beginning and through study completion, an average of 12 weeks)
- Change of risk of falls(beginning and through study completion, an average of 12 weeks)
研究者
Juan Vicente, López Díaz
Director
Omphis Foundation