The Preventive Effects of Neurodynamic Mobilisation
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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedFirst Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2022
CompletedNovember 4, 2024
November 1, 2024
8 months
March 29, 2022
November 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Change from Baseline Muscle Soreness at 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.
up to 4 weeks
Change from Baseline Muscle damage marker (Creatine kinase (U/L)) at 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.).
up to 4 weeks
Change from Baseline Muscle damage marker (Laktat dehidrogenaz (U/L)) at 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.).
up to 4 weeks
Change from Baseline Inflammatory stress marker (Tumor necrosis factor-alfa ((pg/ml)) at 4 weeks
Tumor necrosis factor-alfa (pg/ml), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
up to 4 weeks
Change from Baseline Inflammatory stress marker (Human interleukin-6 (pg/ml)) at 4 weeks
Human interleukin-6 ((pg/ml)), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
up to 4 weeks
Change from Baseline Pressure Pain Threshold (N/cm2) at 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).
up to 4 weeks
Change from Baseline One leg hop test (cm) at 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.
up to 4 weeks
Study Arms (2)
Study Group
EXPERIMENTALFemoral 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.
Placebo Group
PLACEBO COMPARATORFemoral 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uğur Sözlülead
- Gazi Universitycollaborator
Study Sites (1)
Gazi University
Ankara, Beşevler, 06000, Turkey (Türkiye)
Related Publications (1)
Sozlu U, Basar S, Semsi R, Akaras E, Sepici Dincel A. Preventive effect of the neurodynamic mobilization technique on delayed onset of muscle soreness: a randomized, single-blinded, placebo-controlled study. BMC Musculoskelet Disord. 2025 May 10;26(1):464. doi: 10.1186/s12891-025-08723-8.
PMID: 40349018DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Selda Başar, Phd
Gazi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 14, 2022
Study Start
February 20, 2020
Primary Completion
October 20, 2020
Study Completion
May 13, 2022
Last Updated
November 4, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share