Management of chronic shoulder pain in adults with individualized homoeopathic medicines: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quick DASH (disabilities of the arm, shoulder, and hand)
研究概览
简要总结
Chronic shoulder pain is a major public health problem in adults of developing countries. Chronic shoulder pain is considered amongst the most common musculoskeletal conditions throughout the world. The use of homoeopathic medicines is prevalent globally to treat the condition , rigorous research evidence in support of homoeopathy in shoulder pain has remained compromised. Under such circumstances , we intend to undertake this research to explore the effects of individualized homoeopathic medicine in comparison with placebo in the management of chronic shoulder pain in adults .This double-blind, randomized(2:1) placebo controlled trial using individualized homoeopathic medicines along with placebo will be conducted on 40 participants suffering from chronic shoulder pain in- patient departments of D. N. De homoeopathic medical college and hospital. Primary outcome will be measured by using Quick Dash scores & secondary outcome will be measured by using SPADI, MYMOP-2 score and VAS pain scale .All the outcomes will be measured every month up to 3 months. Group differences will be calculated on the intention-to-treat and per-protocol samples. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 with chronic shoulder pain for 3 months or more according to ICD 10 (M25.51)
- •Patients already undergoing regular oral or topical analgesics or NSAID therapy for chronic shoulder pain, provided the medications are stopped completely at least 2 weeks prior study entry
- •Age between 18 and 65 years
- •Patients of either both sex and transgender
- •Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Not providing informed consent of participation
- •Radiological evidence of shoulder joint fracture or dislocation
- •Non-ambulant patients
- •Intra-articular injections within 2 weeks before study entry
- •Cases willing for or requiring immediate surgical intervention or already underwent any major shoulder joint surgery within last 3 months,
- •When the shoulder pain is due to any invasive malignant disease or neoplasia
- •Patients suffering from active local infection of shoulder joint, 8.Patients who are too sick for consultation
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool)
- •Self-reported immune-compromised state, AIDS, hepatitis etc.
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Quick DASH (disabilities of the arm, shoulder, and hand)
时间窗: Baseline, every month, up to 3 months
次要结局
- Shoulder pain and disability index (SPADI)(Baseline, every month, up to 3 months)
- Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2)(Baseline, every month, up to 3 months)
- 10 cm visual analog scale measuring intensity of pain(Daily, via online survey, upto 3 months)
研究者
Sikha Kisku
D. N. De Homoeopathic Medical College & Hospital