Clinical trial NCT05326893: The Preventive Effects of Neurodynamic Mobilisation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Onset Muscle Soreness
Keywords: Delayed onset muscle soreness
Neurodynamic mobilization
Muscle damage
Inflammation
Pain
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2022-04-14
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a randomized, single-blind, sham-controlled clinical trial.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline Muscle Soreness at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline Muscle damage marker (Creatine kinase (U/L)) at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline Muscle damage marker (Laktat dehidrogenaz (U/L)) at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline Inflammatory stress marker (Tumor necrosis factor-alfa ((pg/ml)) at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline Inflammatory stress marker (Human interleukin-6 (pg/ml)) at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline Pressure Pain Threshold (N/cm2) at 4 weeks
timeFrame: up to 4 weeks
measure: Change from Baseline One leg hop test (cm) at 4 weeks
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Beşevler
Study officials:
affiliation: Gazi University
name: Selda Başar, Phd
role: STUDY_CHAIR
References: