Efficacy of Siravyadana in plantar fasciitis: a randomized, open-labeled, controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Foot Function Index (FFI)
研究概览
简要总结
Plantar fasciitis is one of the common foot conditions treated by healthcare providers. The condition affects 10% of the general population, among which 83% belong to active working adults.1 Higher prevalence rate is observed in women compared to men and in those with a body mass index >25kg/m2. Overuse injury due to repetitive strains causing micro-tears of the plantar fascia often causes plantar fasciitis. The condition is primarily a degenerative and noninflammatory. 3 Rest, ice after activity, oral or topical nonsteroidal anti-inflammatory drugs are used as first line treatment. Supportive treatments, including the plantar fascia-specific stretch, calf stretching, appropriate orthotics and night dorsiflexion splinting also help to reduce pain in plantar fasciitis. Local steroid injections to the plantar fascia provide effective short-term pain relief. Ultrasonography-guided focal extracorporeal shock wave therapy is useful for patients with chronic plantar fasciitis. 4,5
Plantar fasciitis closely resembles the condition “Vatakantaka” mentioned in Ayurvedic texts. According to Susrutha, walking on an uneven ground causes pain in the heel due to vata situated in the heels and that is known as “Vatakantaka”. 6 Further, he mentions Siravyadana as the main line of treatment for this condition. 7, 8
Reference:
- Nahin RL. Prevalence and Pharmaceutical Treatment of Plantar Fasciitis in United States Adults. J Pain. 2018 Aug;19(8):885-896.
- Lapidus PW, Guidotti FP. Painful Heel: Report Of 323 Patients With 364 Painful Heels. ClinOrthopRelat Res. 1965 Mar-Apr;39:178-86.
- Buchanan BK, Sina RE, Kushner D. Plantar Fasciitis. [Updated 2024 Jan 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431073/
- Lim AT, How CH, Tan B. Management of plantar fasciitis in the outpatient setting. Singapore Med J. 2016 Apr;57(4):168-70; quiz 171. doi: 10.11622/smedj.2016069.
- Tahririan MA, Motififard M, Tahmasebi MN, Siavashi B. Plantar fasciitis. J Res Med Sci. 2012 Aug;17(8):799-804.
- Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., NidanaSthana. 1/79, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.1, p. 511.
- Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., ChikitsaSthana. 5/23, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.2, p. 213.
- Susrutha, Susruta Samhita, Singhal GD (editor), 2nd Ed., SariraSthana. 8/17, Delhi: Chaukhamba Sanskrit Pratishthan; 2007, Vol.2, p. 101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with inferior heel Pain.
排除标准
- •Chronic pain syndrome or lumbosacral radiculitis
- •Neurological conditions such as peripheral neuropathy, polyneuropathy & radiculopathy
- •Patients with foot and arch issues such as flat foot and high arch foot
- •Calcaneal stress fracture
- •Spondyloarthropathies, Rheumatoid arthritis
- •Osteomyelitis of calcaneum
- •Patients unfit for the procedure of Siravyadana.
结局指标
主要结局
Change in Foot Function Index (FFI)
时间窗: Baseline, week 2, week 4, week 6, week 8, week 10 & week 12
次要结局
- Change in thickness in plantar fascia assessed by high-resolution ultrasonography(Baseline & week 12)
- Satisfaction with the result of the treatment(week 12)
- Change in hs-CRP(Baseline & week 12)
研究者
Pratap Shankar K M
National Ayurveda Research Institute for Panchakarma