The Effects of Connective Tissue Massage Combined With Core Stabilization Exercises on Pain, Functionality, and Endurance in Mechanical Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Curl-Up Test (Static and Dynamic)
研究概览
简要总结
This randomized controlled study will investigate the effects of connective tissue massage combined with core stabilization exercises in patients with mechanical low back pain. Participants will be assigned to two groups: one will receive core stabilization exercises with connective tissue massage, while the other will receive only core stabilization exercises. Pain will be evaluated using the Visual Analog Scale, functionality will be assessed with the Oswestry Disability Index, and endurance will be measured with static and dynamic curl-up, static back endurance, and side bridge tests. Quality of life will be assessed with the SF-36, and instrumental daily living activities will be evaluated with the Lawton & Brody Scale. The results will demonstrate whether adding connective tissue massage to core stabilization exercises will provide additional benefits in pain reduction, functional improvement, endurance, and quality of life compared to exercises alone.
详细描述
This randomized controlled clinical trial will evaluate the effects of connective tissue massage (CTM) combined with core stabilization exercises (CSEs) on pain, functionality, endurance, and quality of life in patients with mechanical low back pain. A total of 29-30 participants aged 20 to 55 years who will be diagnosed with mechanical low back pain will be recruited. Participants will be randomized into two groups:
Experimental group: will receive core stabilization exercises plus connective tissue massage.
Control group: will receive only core stabilization exercises.
All interventions will be delivered under physiotherapist supervision in the physiotherapy and rehabilitation laboratories. The exercise program will include progressive core stabilization exercises performed twice per week for eight weeks, each session lasting approximately 50 minutes (10 minutes warm-up, 30 minutes core stabilization, 10 minutes cool-down). The experimental group will additionally receive 20 minutes of connective tissue massage twice per week during the same 8-week intervention period.
Outcome measures will include:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 20-55 years of age.
- •Participants will have a clinician-confirmed diagnosis of mechanical low back pain and will be referred by specialists in Physical Medicine and Rehabilitation.
- •Participants will have adequate cognitive ability to follow assessments and the treatment protocol and will agree to attend supervised sessions (2×/week for 8 weeks) and to perform daily home exercises.
- •Participants will provide informed consent prior to any study procedures
排除标准
- •Participants will be excluded if they have a history of lumbar spine surgery.
- •Participants will be excluded for conditions affecting the lumbar region, including inflammatory arthritis, tumor, or infectious diseases.
- •Participants will be excluded if they present congenital anomalies of the lumbosacral region or secondary orthopedic problems that could interfere with the study.
- •Participants will be excluded if they have neurological disorders (e.g.,Parkinson's disease, Alzheimer's disease, multiple sclerosis) or systemic diseases such as diabetes mellitus.
- •Any medical condition judged by the investigators to preclude safe participation or adherence to the protocol will lead to exclusion.
研究组 & 干预措施
Core stabilization+connective tissue massage
Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. In addition, each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort. Interventions will be delivered under physiotherapist supervision in the university physiotherapy laboratories.
干预措施: Core Stabilization Exercises (Other)
Core stabilization+connective tissue massage
Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. In addition, each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort. Interventions will be delivered under physiotherapist supervision in the university physiotherapy laboratories.
干预措施: Connective tissue massage (Other)
Core Stabilization Exercises Only
Participants will receive the same supervised core stabilization program as the experimental arm (twice weekly for 8 weeks, ≈50 min per session with progressive exercises from activation to advanced tasks) and the same daily 60-min home exercise prescription. No connective tissue massage will be provided. Sessions will be delivered under physiotherapist supervision in the same laboratory setting to ensure consistency across arms.
干预措施: Core Stabilization Exercises (Other)
结局指标
主要结局
Curl-Up Test (Static and Dynamic)
时间窗: From enrollment to the end of treatment at 8 weeks
Abdominal endurance will be measured by static and dynamic curl-up tests. For the static test, participants will maintain a standardized trunk-flexion position until fatigue. For the dynamic test, participants will perform as many curl-ups as possible within 1 minute. Longer holding times or higher repetitions will indicate greater endurance. Measured in seconds/repetitions, with higher values indicating greater endurance.
Biering-Sørensen Test
时间窗: From enrollment to the end of treatment at 8 weeks.
Back extensor endurance will be evaluated by maintaining the upper body in a horizontal position over the edge of a table while the pelvis and legs are stabilized. Time will be recorded in seconds, with longer duration indicating greater endurance. Higher scores will indicate greater endurance.
Oswestry Disability Index (ODI)
时间窗: From enrollment to the end of treatment at 8 weeks
Functional status will be assessed with the ODI, a 10-item questionnaire scored from 0 to 5 per item, covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and changing pain intensity. Scores will be converted into percentages, with higher scores indicating greater disability. The total score will be calculated as a percentage, where 0% indicates no disability and 100% represents the highest level of disability.
Visual Analog Scale (VAS)
时间窗: From enrollment to the end of treatment at 8 weeks
Pain intensity will be measured using the Visual Analog Scale, a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores will indicate greater pain severity.
Side Bridge Test
时间窗: From enrollment to the end of treatment at 8 weeks.
Spinal stabilizer endurance will be measured in a side-lying position with support on the elbow and feet. Participants will elevate the pelvis to align the body horizontally and maintain this position as long as possible. Longer holding times will indicate higher endurance capacity. The test will be terminated when the participant can no longer maintain the straight body position or after 240 seconds. Higher scores will indicate greater endurance.
次要结局
- Finger-to-Floor Distance Test(From enrollment to the end of treatment at 8 weeks)
- Manual Muscle Testing (MMT, Lovett Scale)(From enrollment to the end of treatment at 8 weeks)
- Short Form-36 Health Survey (SF-36)(From enrollment to the end of treatment at 8 weeks)
- Lawton & Brody Instrumental Activities of Daily Living (IADL) Scale(From enrollment to the end of treatment at 8 weeks)
研究者
Burcu AKKURT
PhD
Fenerbahce University