search
Back to results

The Preventive Effects of Neurodynamic Mobilisation

Primary Purpose

Delayed Onset Muscle Soreness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Femoral nerve neurodynamic mobilization
Femoral nerve placebo neurodynamic mobilization
Sponsored by
Ugur Sozlu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Onset Muscle Soreness focused on measuring Delayed onset muscle soreness, Neurodynamic mobilization, Muscle damage, Inflammation, Pain

Eligibility Criteria

18 Years - 32 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.).
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.).
Change from Baseline Muscle damage marker (Aspartat aminotransferaz (U/L)) at 4 weeks
Aspartate aminotransferase (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 (Alanine transaminase (U/L)) at 4 weeks
Alanine transaminase (U/L) were 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 (Myoglobin (ng/ml)) at 4 weeks
Myoglobin was assessed using an enzyme-linked immunoassay test (minimum detectable concentration: 21ng/ml; Detection range: 21-3.000 ng/ml) following the manufacturer's recommendations (Cobas, 6000, Roche, Germany).
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.
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.
Change from Baseline Inflammatory stress marker (Human interleukin-10 (pg/ml)) at 4 weeks
Human interleukin-10 (IL-10) was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Change from Baseline Inflammatory stress marker (Human interleukin-1β (pg/ml)) at 4 weeks
Human interleukin-1β (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
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 Range of Motion (°) at 4 weeks
The active knee flexion range of motion (°) was measured using a digital goniometer (Baseline number: 12-1057). To measure the knee ROM, the axis of the digital goniometer was attached to the lateral joint space of the knee; the fixed arm was placed in the middle of the femur, between the greater trochanter and the lateral joint space of the knee; and the moving arm was lined up with the lateral malleolus of the fibula. After the measurement, the angle of goniometer was reset to zero and the trial was repeated two times. This method for assessing ROM has been validated previously (ICC: 0.98).
Change from Baseline Eccentric torque (Nm) at 4 weeks
Quadriceps femoris muscle strength (Nm) was measured in the eccentric phase with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA) (ICC: 0,90). During the measurement, the patient's chest, abdomen, thigh, and ankles were fixed with a strap, and the dynamometer rotation axis was aligned with the knee joint axis. Peak torque values were adjusted to create flexion and extension movements between 35-95° and angular velocities of 30°/sec. Then, in order to warm up the individuals and ensure their adaptation to the test, 3 trials were made at the same speed and angle before the test, and after a 30-second rest period, the test was started. Individuals were asked to perform five maximum repetitions at an angular velocity of 30°/sec, and the highest values were recorded as the peak torque value by the dynamometer.
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
February 27, 2023
Sponsor
Ugur Sozlu
Collaborators
Gazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT05326893
Brief Title
The Preventive Effects of Neurodynamic Mobilisation
Official Title
The Preventive Effects of Neurodynamic Mobilization on Delayed Onset Muscle Soreness: A Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ugur Sozlu
Collaborators
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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, range of motion (ROM), muscle strength, and functional status in delayed onset muscle soreness (DOMS). In the study, 32 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 16) and placebo-NM (n = 16). 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), myoglobin, aspartate aminotransferase (AST), and alanine aminotransferase) and inflammation (interleukin-6 (IL-6), interleukin-10, interleukin-1 beta, tumor necrosis factor-alpha, and C reactive protein) biomarkers, pain (activity), pressure pain threshold, ROM, muscle strength (QF, hamstring eccentric/concentric) 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, range of motion (ROM), muscle strength, and functional status in delayed onset muscle soreness (DOMS). In the study, 32 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 16) and placebo-NM (n = 16). 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), myoglobin, aspartate aminotransferase (AST), and alanine aminotransferase) and inflammation (interleukin-6 (IL-6), interleukin-10, interleukin-1 beta, tumor necrosis factor-alpha, biomarkers, pain (activity), pressure pain threshold, ROM, muscle strength (QF, hamstring eccentric/concentric) and performance (one-leg jump, vertical jump) parameters were measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Onset Muscle Soreness
Keywords
Delayed onset muscle soreness, Neurodynamic mobilization, Muscle damage, Inflammation, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was conducted as a randomized, double-blind, placebo-controlled parallel group trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Femoral nerve neurodynamic mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Femoral nerve placebo neurodynamic mobilization
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Muscle Soreness at 4 weeks
Description
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.
Time Frame
up to 4 weeks
Title
Change from Baseline Muscle damage marker (Creatine kinase (U/L)) at 4 weeks
Description
Creatine kinase (U/L) was assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Time Frame
up to 4 weeks
Title
Change from Baseline Muscle damage marker (Laktat dehidrogenaz (U/L)) at 4 weeks
Description
Lactate dehydrogenase (U/L) was assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Time Frame
up to 4 weeks
Title
Change from Baseline Muscle damage marker (Aspartat aminotransferaz (U/L)) at 4 weeks
Description
Aspartate aminotransferase (U/L) was assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Time Frame
up to 4 weeks
Title
Change from Baseline Muscle damage marker (Alanine transaminase (U/L)) at 4 weeks
Description
Alanine transaminase (U/L) were assessed using an enzyme-linked immunoassay as per the manufacturer's protocol (Beckman Coulter, Inc., CA, U.S.A.).
Time Frame
up to 4 weeks
Title
Change from Baseline Muscle damage marker (Myoglobin (ng/ml)) at 4 weeks
Description
Myoglobin was assessed using an enzyme-linked immunoassay test (minimum detectable concentration: 21ng/ml; Detection range: 21-3.000 ng/ml) following the manufacturer's recommendations (Cobas, 6000, Roche, Germany).
Time Frame
up to 4 weeks
Title
Change from Baseline Inflammatory stress marker (Tumor necrosis factor-alfa ((pg/ml)) at 4 weeks
Description
Tumor necrosis factor-alfa (pg/ml), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Time Frame
up to 4 weeks
Title
Change from Baseline Inflammatory stress marker (Human interleukin-6 (pg/ml)) at 4 weeks
Description
Human interleukin-6 ((pg/ml)), was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Time Frame
up to 4 weeks
Title
Change from Baseline Inflammatory stress marker (Human interleukin-10 (pg/ml)) at 4 weeks
Description
Human interleukin-10 (IL-10) was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Time Frame
up to 4 weeks
Title
Change from Baseline Inflammatory stress marker (Human interleukin-1β (pg/ml)) at 4 weeks
Description
Human interleukin-1β (pg/ml) was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.
Time Frame
up to 4 weeks
Title
Change from Baseline Pressure Pain Threshold (N/cm2) at 4 weeks
Description
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).
Time Frame
up to 4 weeks
Title
Change from Baseline Range of Motion (°) at 4 weeks
Description
The active knee flexion range of motion (°) was measured using a digital goniometer (Baseline number: 12-1057). To measure the knee ROM, the axis of the digital goniometer was attached to the lateral joint space of the knee; the fixed arm was placed in the middle of the femur, between the greater trochanter and the lateral joint space of the knee; and the moving arm was lined up with the lateral malleolus of the fibula. After the measurement, the angle of goniometer was reset to zero and the trial was repeated two times. This method for assessing ROM has been validated previously (ICC: 0.98).
Time Frame
up to 4 weeks
Title
Change from Baseline Eccentric torque (Nm) at 4 weeks
Description
Quadriceps femoris muscle strength (Nm) was measured in the eccentric phase with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA) (ICC: 0,90). During the measurement, the patient's chest, abdomen, thigh, and ankles were fixed with a strap, and the dynamometer rotation axis was aligned with the knee joint axis. Peak torque values were adjusted to create flexion and extension movements between 35-95° and angular velocities of 30°/sec. Then, in order to warm up the individuals and ensure their adaptation to the test, 3 trials were made at the same speed and angle before the test, and after a 30-second rest period, the test was started. Individuals were asked to perform five maximum repetitions at an angular velocity of 30°/sec, and the highest values were recorded as the peak torque value by the dynamometer.
Time Frame
up to 4 weeks
Title
Change from Baseline One leg hop test (cm) at 4 weeks
Description
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.
Time Frame
up to 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Başar, Phd
Organizational Affiliation
Gazi University
Official's Role
Study Chair
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Beşevler
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Preventive Effects of Neurodynamic Mobilisation

We'll reach out to this number within 24 hrs