跳至主要内容
临床试验/CTRI/2025/07/091257
CTRI/2025/07/091257尚未招募2/3 期

Efficacy of multimodal approach in the management of chronic mechanical low back pain (katishoolaa) - A Randomized controlled trial

Dr Suman Raichandani1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1 Pain assessed by Numeric Pain Rating Scale and Visual analogue scale

研究概览

简要总结

Millions of people worldwide suffer from the widespread and incapacitating ailment known as chronic mechanical low back pain. Because it causes severe pain, disability, and a decline in the quality of life for people who are affected, it presents as a serious worldwide health burden. There were 619 million LBP sufferers globally in 2020; by 2050, that figure is predicted to rise to 843 million.  As a complex symptom, LBP is linked to a lower quality of life for those who experience it. Among other symptoms, it causes negative social relationships, work absenteeism, functional impairment, fear of movement, stress, anxiety, and depression. The burden of low back pain  is greatly increased by lifestyle variables like smoking, being overweight, not exercising, and getting little sleep.  The main reason why a person with chronic LBP seek medical attention is because they have trouble carrying out everyday functioning tasks.  People with LBP are treated with a variety of therapies to address their range of motion limitations, pain symptoms, and perceptions of their disability. These therapies include pharmaceutical management, manual therapy, therapeutic exercise, patient education regarding lifestyle modifications, and modalities like electrical stimulation, ultrasound, heat, and cryotherapy.  Because of their affordability and effectiveness in managing chronic pain, medication-based treatments  are acknowledged as first-line treatments. The most effective therapeutic options are opioids and NSAIDs. Their long-term effectiveness and possible adverse effects, such as organ damage, ulcers, tiredness and dizziness, may raise questions, though. This method is only feasible and safe in the short term due to the possible adverse effects of medication and the possibility of opiate addiction. Over half of people with LBP experience a return of symptoms, necessitating expensive operations or a reliance on pain medication for symptom management. The long-term effects of current therapies are also variable. As a result, more successful interventions are required.  According to Ayurveda, low back pain is associated with cluster disorders of vata vyadhi, specifically Katigraha, Gridrasi, and Khalli, which have particular common symptoms including pain , stiffness , and suptata.  According to Vata vyadhi, pain is a common symptom. Sneha, Sveda, Samshodana, Agnikarma, Raktamokshana, Lepa, Basti and others are included in the Samanya Chikitsa Sutra for Vata Vyadhi.  When it comes to symptoms like Suptata, Kandu, Chimchimayana, Sthambha, and Grathita with ruja and avagadatara rakta dosha conditions, Alabu is especially recommended.  Because the principle of blood evacuation is comparable in cupping therapy and Alabu Chikitsa, the therapy is called Modified Alabu Chikitsa.  Cupping therapy is regarded as an alternate or additional form of treatment. Researchers have proposed the clinical value and acceptability of cupping therapy in the treatment of LBP, as interest in this pain management technique continues to grow.  Yoga has been shown in prior clinical trials to improve back-related impairment and self-efficacy in individuals with CLBP.  Traditional recommendations for the treatment of Vaat vyadhi include formulas such as Mahanaryana taila for local application and Trayodashang guggulu. Multimodal approach is necessary to provide a complete care for the patient and is the need of hour. Hence the integrative approach is planned to evaluate the efficacy of wet cupping therapy, yoga and medications in the management of chronic Low Back Pain.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients between age group 20 to 60 years irrespective of gender religion occupation and socio economic status 2 Patients fulfilling diagnostic criteria 3 Patients with complaints of low backache for more than 12 weeks 4 Patients who are able to undertake a 2 minute Walk Distance test 5 Pain intensity more than 3 and less than 8 on a 0 to 10 numerical pain rating scale.

排除标准

  • 1 Evidence of central nervous system involvement including symptoms of cauda equina syndrome or the presence of pathological reflexes in the physical examination 2 Recent within the past 2 weeks epidural steroid injection for LBP and/or leg pain 3 Pregnant and lactating females 4 Patients with history of low back pain due to tumors infections congenital disease radiculopathy or fractures neurological diseases like multiple sclerosis transverse myelitis and previous spine surgery 5 Psychiatric disorders such as depression or others liver and renal dysfunction history medication for cardiac failure and a history of cerebrovascular accident or myocardial infarction within 6 months before the day of agreement to enter the trial 6 Suspicion of serious pathology based on red flags noted in the general medical screening Red flags include progressive motor or sensory loss urinary retention or overflow incontinence history of cancer recent invasive spinal procedure and significant trauma relative to age.

结局指标

主要结局

1 Pain assessed by Numeric Pain Rating Scale and Visual analogue scale

时间窗: Day 0 Day 7 Day 14 Day 21 Day 30

2 Heaviness at back region

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3 Stiffness at back region

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4 Numbness at back region

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5 Modified Oswestry Low

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Back Pain Disability score

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6 Range of Motion at the

时间窗: Day 0 Day 7 Day 14 Day 21 Day 30

Lumbar spine by goniometry

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7 Modified Scobers test

时间窗: Day 0 Day 7 Day 14 Day 21 Day 30

次要结局

  • 1 Timed up and go test(2 Roland and morris disability questionnaire)

研究者

发起方
Dr Suman Raichandani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Suman Raichandani

KAHER shri B M K Ayurveda Mahavidyalaya

研究点 (1)

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