Effect of Tok-Sen Massage for Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pain relieving from Visual analogue scale
研究概览
简要总结
The purpose of this clinical trial was to find out whether Tok Sen massage (a massage method with wooden instruments from northern Thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. The main questions it aims to answer are:
Can Tok Sen Massage Relieve Chronic Lower Back Pain? Can Tok Sen massage improve the quality of life of patients with chronic low back pain? Researchers compared Tok Sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain.
Participants will:
Receive Tok Sen massage or pressure massage every week for 1 month. Questionnaires and flexion measurements before and after each massage. After the massage session, fill out the online questionnaire once a month for three months.
详细描述
Low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (YLDs), with a high prevalence of 28%-42% among those aged 40 to 69 years. The prevalence of different occupations in Taiwan ranges from 35% to 90%; according to the summary of the National Health Insurance Database results report: "The annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime Suffering from low back pain. "Most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. Approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. Tok-Sen Massage is a kind of folk therapy in northern Thailand, specializing in musculoskeletal system diseases. This trial selected Pressure Massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain.
This is an open-label and randomized controlled trial. Patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the Tok-Sen Massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the Pressure Massage group received a 40-minute intervention once a week for a total of 4 times.
Massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs.
The evaluation methods are: 1. Oswestry Disability Index (ODI) (baseline and after three interventions), 2. Visual Analogue Scale (VAS)before and after each massage, 3. Trunk flexibility test. before and after each massage.
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)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain for more than 3 months
- •diagnosis of non-specific low back pain
排除标准
- •Spinal surgery history
- •Joint disease
- •Pregnancy
- •Systemic disease
- •Mental disease
- •Bone Mass Measurement less than
结局指标
主要结局
Pain relieving from Visual analogue scale
时间窗: From enrollment to the end of 4 times treatments at 4 weeks
Pain was assessed using the "Pain Visual Analogue Scale" (P-VAS), which is a self-assessment scale consisting of a 10 cm horizontal line anchored on both sides. The endpoint on the left represents "no pain." , the endpoint on the right represents "severe pain". Subjects can mark their pain level on this line based on how they feel. The distance from the position of the subject's mark to the left is the measurement result. The data range is from 0 mm to 100 mm. The degree of pain reduction(1%-100%, more percentage is more effective)
The Oswestry Disability Index
时间窗: From enrollment to the end of follow up at 3 months
Disability assessment uses the Oswestry Disability Index (ODI). The development of ODI was initiated by John O'Brien in 1976. These 10 items are respectively the degree of pain and the impact of pain on self-care, lifting heavy objects, walking ability, sitting ability, standing ability, sleep, social life, sex life and travel. Each option has 6 alternatives. The answer is scored from 0 to 5, with 0 being no pain at all and not affecting life, and 5 being extreme pain causing severe disability, so the "ODI score" ranges from 0 to 50. The calculation method of "ODI disability value": "Euclidean disability index" = (actual score/total number of questions answered × 5) × 100%. For example, all answers to 10 questions are: (actual score/50) × 100%; answer Question 9 is (actual score/45) × 100% (57, 62).
次要结局
- Forward bend fingertip-to-floor distance(From enrollment to the end of 4 times treatments at 4 weeks)
- Left and right side bending fingertip-to-floor distance subtraction(From enrollment to the end of 4 times treatments at 4 weeks)