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临床试验/NCT06193603
NCT06193603已完成不适用

Effectiveness of Cupping Therapy in Patients With Chronic Nonspecific Low Back Pain: a Randomized Sham-controlled Trial

Iran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Functional disability

研究概览

简要总结

Chronic non-specific low back pain is a common condition that can cause disability, physical and psychological impairment, limitations in daily activities, and participation restrictions. It also has significant economic and social impacts. Clinical guidelines recommend non-pharmacological interventions as the first-line treatment, including exercises, psychological therapies, and multidisciplinary rehabilitation. Pharmacological therapies are used when non-pharmacological approaches are not effective. Alternative therapies like cupping therapy have gained attention, but their efficacy is still debated due to limited high-quality studies. Further research is needed to determine the true benefits and effectiveness of cupping therapy in managing chronic low back pain. A recent study found that dry cupping therapy was not superior to sham cupping in improving pain, physical function, mobility, quality of life, psychological symptoms, or medication use in individuals with chronic non-specific low back pain. However, it's important to note that the study used dry cupping therapy in isolation, which may not reflect typical clinical practice. Well-designed clinical trials can provide a better understanding of the potential impact of cupping therapy on various aspects of chronic low back pain. Hence, the primary goal of this randomized clinical trial is to compare the effectiveness of true cupping therapy combined with routine physiotherapy versus sham cupping therapy combined with routine physiotherapy in patients suffering from chronic non-specific low back pain. The study aims to address the following key questions:

  • Does true dry cupping therapy, when combined with routine physiotherapy, provide greater improvement in pain and functional disability for patients with chronic non-specific low back pain?
  • Does true dry cupping therapy, when combined with routine physiotherapy, result in a higher improvement in quality of life for patients with chronic non-specific low back pain?

Participants in the intervention group will undergo 10 sessions of dry cupping therapy, with each session lasting 5 minutes and conducted three times per week. During the sessions, the therapist will move the cups longitudinally in upward-downward and downward-upward directions. In the control group, participants will assume the same positions as the intervention group, but two cups with small holes (<2mm in diameter) will be used to release negative pressure within seconds.

详细描述

RESEARCH OBJECTIVE:

The primary objective of this study is to examine the efficacy of true dry cupping therapy, in combination with routine physiotherapy, in comparison to sham dry cupping therapy, in combination with routine physiotherapy, for managing pain intensity and functional disability in individuals with chronic non-specific low back pain. The secondary objective is to evaluate the impact of 10 treatment sessions on the quality of life of patients with chronic non-specific low back pain.

RESEARCH DESIGN:

This study is a randomized, single-blind, sham-controlled trial conducted at two centers. The allocation ratio is 1:1, with a total of 80 participants with hypertrophic scar tissue. Random assignment to two groups of equal size will be done using the permuted block randomization method, utilizing four-letter blocks (A and B). The random treatment list will be placed in sealed and numbered envelopes, with letter A representing true dry cupping therapy and letter B representing sham dry cupping therapy. The random assignment process will be conducted by an individual outside the research team prior to the commencement of the study.

PROCEDURE:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Single (Participant) Participants in the control group will undergo a similar procedure to those in the intervention group. Two cups will be placed on the lumbar region, but the sham cups will have small holes (<2mm in diameter) to release negative pressure quickly. Additionally, to reduce bias, the data analyst will be blinded to the group assignments of the participants. Each participant will be identified by a unique numerical code to maintain anonymity.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic non-specific low back pain lasting for a minimum of 3 months.
  • The pain intensity is rated between 3 and 6 on the visual analog scale.
  • The body mass index falls between 19 and
  • No restrictions for therapeutic exercise and electrotherapy.

排除标准

  • The presence of comorbidities such as diabetes and cardiovascular problems.
  • The presence of spinal column deviations, such as scoliosis, is observed.
  • Signs of serious pathology of the spine (eg, fractures, inflammatory diseases, infection or tumours).
  • Consecutive absence of more than three sessions.
  • Patients' dissatisfaction with their participation in the study
  • Individuals who have been treated with cupping in the past.
  • Neurological, vestibular, visual or auditory deficits.
  • Currently performing physical therapy.
  • Irradiated lumbar or sacroiliac pain.
  • Fibromyalgia

结局指标

主要结局

Functional disability

时间窗: Change from baseline at 4-week and 6-week

The Persian version of the Oswestry Disability Index (ODI) will be employed to assess changes in functional disability. This questionnaire comprises 10 activities of daily living and yields a total score ranging from 0 to 100. A score below 25 indicates minimal disability, while scores between 25 and 50 represent moderate disability. Scores between 50 and 75 indicate severe disability, and scores between 75 and 100 reflect acute disability. The Persian version of this questionnaire has been previously validated and shown to be reliable in previous studies.

Pain intensity

时间窗: Change from baseline at 4-week and 6-week

The Numeric Pain Rating Scale (NPRS) will be utilized to assess changes in pain levels. This scale ranges from 0 to 100, with 0 representing no pain and 100 representing the maximum level of pain experienced by the patient. The NPRS has demonstrated responsiveness in measuring pain levels among individuals with low back pain.

次要结局

  • Quality of life assessment(Change from baseline at 4-week and 6-week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Cupping Therapy in Chronic Nonspecific Low Back Pain | 临床试验