Delayed Onset Muscle SorenessNCT05326893
The Preventive Effects of Neurodynamic Mobilisation
A study testing Femoral nerve neurodynamic mobilization in people with Delayed Onset Muscle Soreness, run by Uğur Sözlü at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Femoral nerve neurodynamic mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 13 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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, 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.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Femoral nerve neurodynamic mobilization, Femoral nerve placebo neurodynamic mobilization
- Keywords
- Delayed onset muscle soreness, Neurodynamic mobilization, Muscle damage, Inflammation, Pain
- Medical subject headings
- Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve neurodynamic mobilizationOther
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 mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Femoral nerve placebo neurodynamic mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Feb 2020
- Primary completion20 Oct 2020
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Onset Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted as a randomized, single-blind, sham-controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uğur Sözlü
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, Uğur Sözlü, Gazi University
- Investigators
- Selda Başar, Phd, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326893
- Sponsor's protocol ID
- 02.10.2019 / 270
- Status last verified
- Nov 2024
- First submitted
- 29 Mar 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40349018
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05326893
- Acronym / sponsor ID
- 02.10.2019 / 270
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- Delayed onset muscle soreness, Neurodynamic mobilization, Muscle damage, Inflammation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Uğur SözlüUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted as a randomized, single-blind, sham-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Femoral nerve neurodynamic mobilizationFemoral 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 comparator | Other: Femoral nerve placebo neurodynamic mobilizationFemoral 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. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral nerve neurodynamic mobilizationThe 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. | Other | Study Group |
| Femoral nerve placebo neurodynamic mobilizationThe 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. | Other | Placebo Group |
Primary outcome
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.
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.).
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.).
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.
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 40349018Sozlu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Başar, Phd study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve neurodynamic mobilization in people with Delayed Onset Muscle Soreness, run by Uğur Sözlü at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Muscle Soreness at 4 weeks (time frame: up to 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.