Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized 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
- 4
- 主要终点
- Changes in widespread pressure pain thresholds between baseline and follow-up periods
研究概览
简要总结
This randomized clinical trial will investigate changes in pain intensity and nociceptive gain processing after the application of either physical therapy or surgery in women with carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain intensity, widespread pressure pain sensitivity and segmental thermal changes after the application of a physical therapy program based on desensitization maneuvers of the central nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up periods. We hypothesize that the physical therapy intervention targeted to desensitization of the central nervous system is more effective than surgical intervention for modulating altered nociceptive gain processing in women with CTS.
详细描述
There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a complex pain syndrome including both peripheral and central sensitization mechanisms. In fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain processing. In addition, these sensitization processes seem to be independent of electro-diagnostic findings. Previous studies support the use of physical therapy and surgical interventions for the management of pain and disability in these patients. However, there is no evidence related to changes in nociceptive gain process after the application of any therapeutic intervention. Preliminary evidence suggests that manual therapies can modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized clinical trial to determine if manual therapies including desensitization maneuvers of the central nervous system are effective to decrease widespread pressure pain and thermal pain hypersensitivity in women with CTS.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pain and paresthesia in the median nerve distribution
- •increasing symptoms during the night,
- •positive Tinel sign,
- •positive Phalen sign,
- •symptoms had to have persisted for at least 6 months
- •deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
排除标准
- •any sensory/motor deficit related to the ulnar or radial nerve;
- •older than 65 years of age;
- •previous surgical intervention or steroid injections;
- •multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- •history of neck, shoulder, or upper limb trauma (whiplash);
- •history of a systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
- •history of other medical conditions (eg, rheumatoid arthritis, fibromyalgia);
- •pregnancy
结局指标
主要结局
Changes in widespread pressure pain thresholds between baseline and follow-up periods
时间窗: Baseline and 3, 6, 9 and 12 months after the intervention.
Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.
次要结局
- Changes in pain intensity between baseline and follow-ups periods(Baseline and 3, 6, 9 and 12 months after the intervention)
- Changes in heat and cold pain thresholds between baseline and follow-up periods(Baseline and 3, 6, 9 and 12 months after the intervention)
研究者
César Fernández-de-las-Peñas
Proffesor
Universidad Rey Juan Carlos