Improvement in Pain and Function Following a Therapeutic Exercise Program and Dry Needling in Older Adults With Knee Osteoarthritis: A Randomized Double-blind Multicenter Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
研究概览
简要总结
This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.
详细描述
Therapeutic exercise and dry needling each relieve pain and improve function, but they are different treatment tools.
Therapeutic exercise takes a multitude of forms and results in numerous systemic and local effects, some of which have been investigate among people with knee osteoarthritis. Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of this therapeutic approach is to improve muscle strength, given that weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen internal knee forces, reduce pain and improve physical function.
Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain and improve function with high recommended evidence (grade A) effectiveness for upper-quarter myofascial pain, but poorly understood in knee osteoarthritis patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 62 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 62 years and older.
- •Unilateral or bilateral disfunction and/or knee pain.
- •Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
- •At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.
排除标准
- •Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
- •Previous knee or hip joint replacement surgery of the affected joint.
- •Any other surgical procedure of the lower limbs in the previous 6 months.
- •Rheumatoid arthritis.
- •Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
- •Alcohol or drugs consumption.
- •Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
- •Conservative or invasive physical therapy (previous 6 months or during follow-up).
- •Taking antiaggregant or anticoagulant medications.
- •Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.
- •Inability to comprehend and complete study assessments or comply with study instructions.
- •Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
- •Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .
研究组 & 干预措施
Exercise and dry needling
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion.
干预措施: Therapeutic exercise (Other)
Exercise and dry needling
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion.
干预措施: Dry needling (Device)
Exercise and sham dry needling
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base.
干预措施: Therapeutic exercise (Other)
Exercise and sham dry needling
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base.
干预措施: Sham dry needling (Device)
结局指标
主要结局
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
时间窗: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.
次要结局
- Mini-Mental State Examination (MMSE)(Base line and 12 months follow-up)
- The Timed Up & Go Test(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
- EuroQol-5(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
- Barthel Index(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
- Numeric Pain Rating Scale (NPRS)(Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up)
研究者
Josue Fernandez Carnero
PhD
Universidad Rey Juan Carlos