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临床试验/NCT06593691
NCT06593691撤回不适用

Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
110
试验地点
1
主要终点
pain intensity

研究概览

简要总结

Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between the ages of 18-65
  • •Volunteering to participate in the study
  • •Having low back pain that has persisted for at least 3 months

排除标准

  • •History of surgery in the waist area
  • •Discopathy at a different level of the spine (Modic Type 3)
  • •Presence of tumor in the spine
  • •Infection in the discs
  • •Having an inflammatory disease
  • •Presence of neurological involvement
  • •Spondylosis
  • •Spinal Stenosis
  • •Spondylolisthesis
  • •Radiculopathy
  • •Having received treatment for low back pain in the last 3 months

研究组 & 干预措施

Conventional treatment group

Active Comparator

In conventional treatment, Hot Pack, TENS, therapeutic ultrasound and exercise program will be given by the hospital staff.

干预措施: conventional treatment (Other)

Conventional treatment + Multiwave Locked System Laser treatment group

Experimental

Multiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment.

干预措施: conventional treatment (Other)

Conventional treatment + Multiwave Locked System Laser treatment group

Experimental

Multiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment.

干预措施: Conventional treatment + multi-wave locked system laser treatment (Other)

结局指标

主要结局

pain intensity

时间窗: Through study completion, an average of 1 year

Numerical Pain Rating Scale: Ratings from 0 to 10 range from no pain to the highest pain level imaginable. Studies show that a 2-point change in the evaluation made with this scale indicates a clinically significant change beyond the limits of measurement error.Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

次要结局

  • Functionality(Through study completion, an average of 1 year)
  • Tactile Acuity(Through study completion, an average of 1 year)
  • Pressure Pain Thereshold(Through study completion, an average of 1 year)
  • Assessment of Quality of life(Through study completion, an average of 1 year)
  • Sleep Quality(Through study completion, an average of 1 year)
  • Patient Satisfaction(Through study completion, an average of 1 year)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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