A Comparison of the Efficacy of Physical Therapy and Radial Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- The Boston carpal tunnel questionnaire (BCTQ)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common of all entrapment syndromes with a prevalence of 1-5%. Electrodiagnostic testing is used to make a definite diagnosis. The mainstay of the pathophysiology of CTS includes mechanical damage to the median nerve due to build up of pressure in the carpal tunnel and nerve ischaemia. Physical therapy (PT) in particular is the conventional non-surgical treatment of choice in the management of mild to moderate CTS, resulting in pain reduction and improved function.
Extracorporeal shock wave therapy (ESWT) is a non invasive treatment method in which high frequency sound waves are applied to the body. The mechanism of action of ESWT in the treatment of CTS remains largely unknown.
Eventhough there are many therapeutic options in the treatment of mild to moderate CTS, there is no consensus on the most effective treatment (4). ESWT has become a desirable treatment option in recent years. However, due to small patients numbers in trials to date and a lack of placebo controlled studies, the efficacy of this treatment option is still under debate. This study aims to compare the efficacy of RESWT to the recommended conventional PT modalities, including therapeutic US, in the treatment of CTS with regards to nociceptive and neuropathic pain, functionality and nerve conduction study outcomes.
详细描述
Carpal tunnel syndrome (CTS) is the most common of all entrapment syndromes with a prevalence of 1-5%. CTS describes the compression of the median nerve as it travels through the carpal tunnel of the wrist, largely resulting in sensory symptoms of paraesthesia and pain in the areas of the hand innervated by the nerve. CTS can also lead to muscle atrophy, loss of motor function and disability of the hand. Electrodiagnostic testing is used to make a definite diagnosis. The mainstay of the pathophysiology of CTS includes mechanical damage to the median nerve due to build up of pressure in the carpal tunnel and nerve ischaemia. Chronic compression of the median nerve also results in neuronal depolarisation and the release of neuropeptides such as substance P and calcitonin-gene-related peptide. These neuropeptides stimulate the release of endothelial nitric oxide thus triggering vasodilatation and neurogenic inflammation .
Management of CTS depends on disease severity. Physical therapy (PT) in particular is the conventional non-surgical treatment of choice in the management of mild to moderate CTS, resulting in pain reduction and improved function. Recommended PT modalities include laser, ultrasound and liquid paraffin therapy. US therapy in particular has given satisfactory results in the treatment of mild to moderate CTS. The biophysical effects of US have been shown to trigger nerve regeneration and healing.
Extracorporeal shock wave therapy (ESWT) is a non invasive treatment method in which high frequency sound waves are applied to the body . ESWT can be divided into radial (RESWT) and focused (FESWT) based on the design of the reflector and resultant pressure and energy applied. Animal studies have shown that ESWT, and especially RESWT can be successfully used in the treatment of peripheral nerve lesions, improving nerve regeneration and functional activity . Human studies on its uses in the treatment of peripheral neuropathies such as interdigital neuroma, distally symmetric polyneuropathy and CTS have also given promising results . The mechanism of action of ESWT in the treatment of CTS remains largely unknown. However, it is believed that the antiinflammatory, angio- and neuro-genic, effects of ESWT encourages tissue regeneration in CTS thus reducing the patient's symptoms and promoting an improvement in function. Moreover, RESWT rather than FESWT maybe the better therapeutic option in CTS as it can be applied to a wider area, incorporating both the median nerve and surrounding tissues.
Eventhough there are many therapeutic options in the treatment of mild to moderate CTS, there is no consensus on the most effective treatment. ESWT has become a desirable treatment option in recent years. However, due to small patients numbers in trials to date and a lack of placebo controlled studies, the efficacy of this treatment option is still under debate. This study aims to compare the efficacy of RESWT to the recommended conventional PT modalities, including therapeutic US, in the treatment of CTS with regards to nociceptive and neuropathic pain, functionality and nerve conduction study outcomes.
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)
盲法说明
All pre and post study evaluations will be performed by a single physical medicine and rehabilitation specialist blind to the patients' treatment groups. Patients will be randomised into the groups by a second physical medicine and rehabilitation specialist. PT wil be conducted by a single experienced physiotherapist. All data analysis will be conducted by a PMR specialist blind to the treatment provided.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have symptoms of CTS for more than three months with physical examination and electrophysiological findings consistent with mild to moderate CTS
排除标准
- •Presence of other sensory or motor neuropathies
- •History of surgery, trauma or fracture of the index hand and wrist
- •History of corticosteroid injection or PT of the index wrist within the past three months.
结局指标
主要结局
The Boston carpal tunnel questionnaire (BCTQ)
时间窗: Change from Baseline BCTQ at 3 weeks post-treatment
This questionnaire determines symptom severity (BCTQs) and functional outcome (BCTQf) specific to CTS using a scale for each. BCTQs is determined using 11 questions each with 5 answers to choose from scored from 1 to 5 giving a BCTQs total out of 55. The higher the score the greater the symptom severity. BCTQf questions the difficulty of 8 functional activities scored from 1 to 5 giving a BCTQf total out of 40. The higher the score the worse the functional capacity
次要结局
- Leeds Assesment of Neuropathic Symptoms and Signs (LANSS)(Change from Baseline LANSS at 3 weeks post-treatment)
- Visual analogue scale (VAS)(Change from Baseline VAS at 3 weeks post-treatment)
研究者
Gonca Saglam
Head of Physical medicine and rehabilitation department
Erzurum Regional Training & Research Hospital
