Repertorial approach of pain management in cervical radiculopathy in adults by using individualized homoeopathic medicines: Double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- 0-10 numeric rating scale measuring intensity of
研究概览
简要总结
Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots. The annual incidence is 107.3 per 100,000 for men and 63.5 per 100,000 for women. The incidence seems to peak in the fourth and fifth decades in life. Risk factors include lifting heaving objects, frequent diving from a board, driving equipment that vibrates, and trauma. Up to 30% of patients report the onset of pain in neck and arms when sitting, walking, or standing. Though the use of homoeopathic medicines is extensive globally to treat the condition, research evidence in favor of homeopathy is not well marked. So, we intend to undertake the trial to evaluate the efficacy and safety of homoeopathic medicines in the treatment of cervical radiculopathy. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in cervical radiculopathy has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homeopathic medicines in the treatment of cervical radiculopathy in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 117 adult participants with cervical radiculopathy at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is Numerical pain rating scale (NPRS), to be measured every month, up to 2 months. Secondary outcome measures are McGill Pain Questionnaire short-form (McGillPQ-SF) and Neck Disability Index (NDI), to be measured every month, up to 2 months. Comparative analysis will be carried out to detect group differences.
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
- •Patients suffering from cervical radiculopathy (ICD10 CM code M54.12) for 3 months or more who shows Spurling’s test positive and Bakody’s sign or positive shoulder abduction test.
- •Age between 18 and 65 years
- •Participants of either sex or transgender
- •Literate participants, ability to read and write in English, Bengali and/or Hindi.
- •Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
- •Providing with written informed consent voluntarily.
排除标准
- •Cases with complications such as incomplete neurological recoveries, disc prolapse, disc herniation.
- •Patients with the history of taking spinal steroid injection within 6 months.
- •Patients on regular NSAIDS therapy.
- •Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, or uncontrolled cardiovascular disease.
- •Vulnerable population.
- •unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Pregnant and puerperal women, lactating mothers.
- •Patients with a habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Self-reported immune-compromised states.
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months.
- •Simultaneous participation in any other clinical trials.
结局指标
主要结局
0-10 numeric rating scale measuring intensity of
时间窗: Baseline, month 1, month 2
pain
时间窗: Baseline, month 1, month 2
次要结局
- Neck disability index(Baseline, month 1, month 2)
- McGill Pain Questionnaire Short Form(Baseline, month 1, month 2)