Efficacy of Individualized Homoeopathic Medicines in the Pain Management of Calcaneal spur: A Double-blind, Randomized Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) for pain.
研究概览
简要总结
A calcaneal spur, or commonly known as a heel spur, occurs when bony outgrowth forms on the heel bone. Calcaneal spur can be located at the back of the heel (Dorsal heel spur) or under the sole (Plantar heel spur). The Dorsal spur are usually associated with Achilles tendinopathy while spurs which are present under the sole are associated with Plantar fascitis. Frequency of calcaneal spurs rose with age in patients of Osteoarthritis and Rheumatoid arthritis. Prevalence is 16.3% and 6.5% for males and females respectively, though more frequent in females. The conservative treatment includes Non- steroidal anti-inflammatory drugs, Cortisone injection, Endoscopic plantar fasciotomy, In-step fasciotomy, Extracorporeal Shock Wave Therapy. In this double-blind, randomized, placebo-controlled trial at The Calcutta Homoeopathic Medical College and Hospital, 128 patients suffering from Calcaneal spur will be randomized to either individualized homoeopathic medicines (verum; n=64) or identical-looking placebo (control; n=64). We aim to investigate whether there are any differences in outcomes between these two groups over 6 months of intervention. Visual Analog Scale (VAS) for pain measurement and Lower Extremity Functional Scale (LEFS) for the measurement of lower extremity function and quality of life will be used as the primary and secondary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Cases suffering from calcaneal spur (ICD 10 code M77.30)
- •Chronic nature of the condition in question (atleast 6 months of symptom manifestation).
- •Subject must be symptomatic at screening and willing to maintain same environment throughout the study.
- •Literate patient: ability to read Bengali and/ or, English and capability and willingness to give inform consent to comply with the study procedure.
- •Confirmed Radiological diagnosis of Calcaneal spur.
排除标准
- •Cases too sick for consultation.
- •Patient unwilling to take part or not giving consent to join the study.
- •Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Undergoing any kind of treatment for chronic disease within last 3 months.
- •Self-reported immune compromised state.
- •Substance abuse and/or dependence.
- •Pregnant and lactating women.
- •Taking medications with analgesic or anti-inflammatory effects.
结局指标
主要结局
Visual analog scale (VAS) for pain.
时间窗: At baseline, after 3 months and 6 months
次要结局
- Lower Extremity Functional scale (LEFS) for measurement of lower extremity function and quality of life.(At baseline, after 3 months and 6 months.)
