Preventive Effect of Femoral Nerve Neurodynamic Mobilization Against Maximal Eccentric Exercise-induced Muscle Damage of the Knee Extensors: a Randomized, Single-blinded, Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from Baseline Muscle Soreness at 4 weeks
研究概览
简要总结
In the study, 34 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 17) and SHAM-NM (n = 17). After the initial evaluation of the individuals, femoral nerve NM and placebo NM techniques were administered three sets a day with ten repetitions for three days a week for three weeks. Three days after the end of the applications, the second evaluations were made and the DOMS creation protocol for the quadriceps femoris (QF) muscle was initiated. In order to trigger DOMS in individuals, 30 sets and 10 repetitions of eccentric knee extension (35°-95° flexion angles, 30°/sec speed) were performed on the dominant lower extremity with an isokinetic dynamometer. Baseline evaluations were repeated immediately after the DOMS protocol, and at hours 24, 48, and 72. During evaluations, muscle damage (serum creatine kinase (CK), lactate dehydrogenase (LDH), and inflammation (interleukin-6 (IL-6), tumor necrosis factor-alpha) biomarkers, pain (activity), pressure pain threshold, and performance (one-leg jump, vertical jump) parameters were measured.
详细描述
The aim of this study was to investigate the effects of neurodynamic mobilization (NM) technique on muscle damage and inflammation biomarkers, and pain, pressure pain threshold, and functional status in delayed onset muscle soreness (DOMS). In the study, 34 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 17) and SHAM-NM (n = 17). After the initial evaluation of the individuals, femoral nerve NM and placebo NM techniques were administered three sets a day with ten repetitions for three days a week for three weeks. Three days after the end of the applications, the second evaluations were made and the DOMS creation protocol for the quadriceps femoris (QF) muscle was initiated. In order to trigger DOMS in individuals, 30 sets and 10 repetitions of eccentric knee extension (35°-95° flexion angles, 30°/sec speed) were performed on the dominant lower extremity with an isokinetic dynamometer. Baseline evaluations were repeated immediately after the DOMS protocol, and at hours 24, 48, and 72. During evaluations, muscle damage (serum creatine kinase (CK), lactate dehydrogenase (LDH), and inflammation (interleukin-6 (IL-6), tumor necrosis factor-alpha) biomarkers, pain (activity), pressure pain threshold, and performance (one-leg jump, vertical jump) parameters were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Being in the age range of 20-32 years.
- •Being male (Because gender difference in the magnitude of eccentric exercise-induced muscle damage might exist as shown in previous studies, only men were recruited in the present study.)
- •Being inactive according to activity guidelines published by the American College of Sports Medicine (less than 30 minutes of moderate physical activity as five times a week).
排除标准
- •Absence of DOMS symptoms,
- •History of vascular disease,
- •Recent injury or surgery to their lower extremity,
- •Neurological impairments and regular use of pain and inflammation medications.
研究组 & 干预措施
Study Group
Femoral nerve neurodynamic mobilization group
T1: Baseline measurements were made and blood samples were taken for biochemical analysis.
NM and placebo NM techniques were applied for three weeks, three times a week, and totaling nine visits. At the end of the third week, it was waited 3 days to eliminate the acute effect of NM.
T2: Baseline measurements and blood samples were repeated a second time.
The protocol for establishing the DOMS was applied on the same day.
T3: Following the protocol for inducing the DOMS, the baseline measurements were repeated for the third time without any interruption, and the blood sample was taken.
T4-T5-T6: The first measurements and blood sample collections were repeated for the fourth, fifth and sixth times, respectively, 24h, 48h, 72h after the DOMS protocol.
干预措施: Femoral nerve neurodynamic mobilization (Other)
Placebo Group
Femoral nerve placebo neurodynamic mobilization group
T1: Baseline measurements were made and blood samples were taken for biochemical analysis.
NM and placebo NM techniques were applied for three weeks, three times a week, and totaling nine visits. At the end of the third week, it was waited 3 days to eliminate the acute effect of NM.
T2: Baseline measurements and blood samples were repeated a second time.
The protocol for establishing the DOMS was applied on the same day.
T3: Following the protocol for inducing the DOMS, the baseline measurements were repeated for the third time without any interruption, and the blood sample was taken.
T4-T5-T6: The first measurements and blood sample collections were repeated for the fourth, fifth and sixth times, respectively, 24h, 48h, 72h after the DOMS protocol.
干预措施: Femoral nerve placebo neurodynamic mobilization (Other)
结局指标
主要结局
Change from Baseline Muscle Soreness at 4 weeks
时间窗: up to 4 weeks
Muscle soreness was assessed using a 100 mm visual analog scale (0 = no soreness, 10 = excruciatingly painful). Each subject walked down 10 steps of stairs and asked to indicate the soreness level on the line. The marked point was measured with a ruler and recorded in millimeters.
Change from Baseline Muscle damage marker (Creatine kinase (U/L)) at 4 weeks
时间窗: up to 4 weeks
Creatine kinase (U/L) was assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Change from Baseline Muscle damage marker (Laktat dehidrogenaz (U/L)) at 4 weeks
时间窗: up to 4 weeks
Lactate dehydrogenase (U/L) was assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Change from Baseline Inflammatory stress marker (Tumor necrosis factor-alfa ((pg/ml)) at 4 weeks
时间窗: up to 4 weeks
Tumor necrosis factor-alfa (pg/ml), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Change from Baseline Inflammatory stress marker (Human interleukin-6 (pg/ml)) at 4 weeks
时间窗: up to 4 weeks
Human interleukin-6 ((pg/ml)), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Change from Baseline Pressure Pain Threshold (N/cm2) at 4 weeks
时间窗: up to 4 weeks
The pressure pain threshold ((N/cm2) ) was measured using a digital pressure algometer (JTECH Medical Industries, Salt Lake City, US) at the midpoint of quadriceps femoris muscle and the other at 5 cm above the superior pole of the patella (representing the musculotendinous junction). The average value of three trials was used in the analysis. PPT measurements were found to have acceptable intra and inter-observer reliability (ICC 0.7).
Change from Baseline One leg hop test (cm) at 4 weeks
时间窗: up to 4 weeks
In the one leg hop test (cm), participants required to stand on one leg to be tested, to jump off and to land on that leg without losing balance. Three hops (with 60 sec rest between hops) were performed and the distance hopped was measured with a standard tape measure. Mean value of distance was recorded as centimeter.
次要结局
未报告次要终点
研究者
Uğur Sözlü
Principal Investigator
Gazi University