NCT05326893

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

March 29, 2022

Last Update Submit

November 1, 2024

Conditions

Keywords

Delayed onset muscle sorenessNeurodynamic mobilizationMuscle damageInflammationPain

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

EXPERIMENTAL

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.

Other: Femoral nerve neurodynamic mobilization

Placebo Group

PLACEBO COMPARATOR

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.

Other: Femoral nerve placebo neurodynamic mobilization

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.

Study Group

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.

Placebo Group

Eligibility Criteria

Age18 Years - 32 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Gazi University

Ankara, Beşevler, 06000, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

InflammationPain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Selda Başar, Phd

    Gazi University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study was conducted as a randomized, single-blind, sham-controlled clinical trial.
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

Locations