The Preventive Effects of Neurodynamic Mobilisation

Delayed Onset Muscle Soreness Clinical Trial

Official title:

The Preventive Effects of Neurodynamic Mobilization on Delayed Onset Muscle Soreness: A Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326893
• Other study ID #: 09.12.2019 / 270
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: May 10, 2022

Study information

• Verified date: February 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 10, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Onset Muscle Soreness
• Myalgia

Intervention

Other:
• Femoral nerve neurodynamic mobilization
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
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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Besevler

Sponsors (2)

Lead Sponsor	Collaborator
Ugur Sozlu	Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.).	up to 4 weeks
Primary	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.).	up to 4 weeks
Primary	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).	up to 4 weeks
Primary	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
Primary	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
Primary	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.	up to 4 weeks
Primary	Change from Baseline Inflammatory stress marker (Human interleukin-1ß (pg/ml)) at 4 weeks	Human interleukin-1ß (pg/ml) was assessed using a sandwich enzyme linked immunoassay test as per the manufacturer's protocol.	up to 4 weeks
Primary	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
Primary	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).	up to 4 weeks
Primary	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.	up to 4 weeks
Primary	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