Examining the Effectiveness of Connective Tissue Massage Applied in Addition to Exercise in Individuals With Chronic Low Back Pain: A Randomized Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Disability Level
研究概览
简要总结
Connective tissue massage (CTM) is a manual therapy method that aims to modulate the autonomic response using special stroking techniques performed on connective tissue, and its analgesic effects are described in the literature. However, studies examining the effects of CTM on multidimensional parameters such as mobility, flexibility, endurance, balance, proprioception, emotional state, and quality of life, in addition to pain and disability in chronic low back pain, are limited.
This study is designed as a randomized controlled trial to evaluate the multifaceted effects of KDM applied in addition to exercise and sham massage in individuals with chronic low back pain. The study will include a total of 40 participants aged 18-65 years who have experienced low back pain for at least six months. The eight-week interventions will be conducted twice weekly; all assessments will be performed before and after treatment. The study will assess pain (VAS), functional status (RMDQ), quality of life (NHP), fatigue (FSS), sleep quality (PUKİ), lumbar mobility, flexibility, balance, core endurance, and autonomic functions.
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
- None
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
- 是
入选标准
- •Participants aged 18-65 who have had chronic low back pain in the past 6 months, have a VAS score above 3, do not have any disease that prevents them from working, and are volunteers will be included in the study.
排除标准
- •pregnant women,
- •individuals with fibromyalgia and chronic fatigue syndrome,
- •individuals with uncontrolled hypertension,
- •cancer, and diabetes,
- •individuals with lumbar spine fractures and those who have undergone surgical interventions in the back region,
- •and individuals who are unwilling or uncooperative.
研究组 & 干预措施
Intervention
Exercise + connective tissue massage
干预措施: Connective tissue massage (Other)
Sham
Exercise + sham connective tissue massage
干预措施: Sham connective tissue massage (Other)
结局指标
主要结局
Disability Level
时间窗: From the enrollement to 8 weeks
Roland-Morris Disability Questionnaire: The Roland-Morris Disability Questionnaire (RMDQ) is one of the most widely used tools developed to assess the functional status of patients with low back pain. This questionnaire is a self-administered scale used to measure disability in individuals with low back pain, and it is based on selected statements from the Sickness Impact Profile.
Flexibility
时间窗: From the enrollement to 8 weeks
Hamstring flexibility: The participant will be asked to raise one leg upwards without bending the knee while lying on their back. At the final point, the distance between the lateral malleolus and the bed will be measured.
Core Muscle Endurance
时间窗: From the enrollement to 8 weeks
Core muscle static endurance will be assessed using the McGill Static Endurance Test Battery. This test will be evaluated using trunk flexion, extension, and right and left lateral bridge tests. A stopwatch will be used for measurements. Results will be recorded in seconds. The test ends when the position is compromised or the participant states they cannot continue. Trunk Flexion Test Trunk Extension Test Lateral Bridge Test
次要结局
- Balance(From the enrollement to 8 weeks)
- lumbar region mobility(From the enrollement to 8 weeks)
- Sleep Quality(From the enrollement to 8 weeks)
- Fatigue Severity(From the enrollement to 8 weeks)
- Quality of Life Level(From the enrollement to 8 weeks)
- Pain Severity(From the enrollement to 8 weeks)
研究者
Berna Çağla Balkışlı
Assistant Professor
Okan University