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Completed

NCT Number: NCT05326893

The Preventive Effects of Neurodynamic Mobilisation

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.

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Key information

Conditions

Delayed Onset Muscle Soreness Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–32 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Beşevler, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femoral nerve neurodynamic mobilization

Other

The mobilization was carried out with the patient lying on the non-dominant side in a total flexion position, and the therapist performed the hip extension movement with the knee joint kept in flexion till the patient felt soreness or pain. This position was held for three seconds and then released. This tensioning maneuver was repeated in three sets of ten repetitions at each session and an interval of 2 min between series were performed. A total of nine sessions were performed within three weeks.

Femoral nerve placebo neurodynamic mobilization

Other

The individual was asked to lie on his non-dominant side and keep his head in the midline. In this position, while the pelvis was stabilized, the upper leg, which was in full knee extension, was grasped and the hip was abducted for 3 seconds. This maneuver was repeated in three sets of ten repetitions at each session and an interval of 2 min between series were performed. A total of nine sessions were performed within three weeks.

Primary outcomes

  1. Change from Baseline Muscle Soreness at 4 weeks

    Time frame: 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.

  2. Change from Baseline Muscle damage marker (Creatine kinase (U/L)) at 4 weeks

    Time frame: 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.).

  3. Change from Baseline Muscle damage marker (Laktat dehidrogenaz (U/L)) at 4 weeks

    Time frame: 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.).

  4. Change from Baseline Inflammatory stress marker (Tumor necrosis factor-alfa ((pg/ml)) at 4 weeks

    Time frame: 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.

  5. Change from Baseline Inflammatory stress marker (Human interleukin-6 (pg/ml)) at 4 weeks

    Time frame: up to 4 weeks

    Human interleukin-6 ((pg/ml)), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.

  6. Change from Baseline Pressure Pain Threshold (N/cm2) at 4 weeks

    Time frame: 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).

  7. Change from Baseline One leg hop test (cm) at 4 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uğur Sözlü

Other

Collaborators

  • Gazi University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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