Central Nervous System SensitizationNCT04255212
Effects of Soft Tissue Treatment vs Mechanisms Explanation to Treat Delayed Onset Muscles Soreness Among Sport Climbers
A study testing Soft tissue treatment, Mechaninsms explanation and Neurodynamic treatment in people with Central Nervous System Sensitization and Peripheral Nervous System Disorders, run by University of Turin, Italy at 2 sites in Italy.
Trial summary
The aim of the present research is to define the effects of short manual treatment of soft tissues compared to mechanisms explaining in Delayed Onset Muscle Soreness (DOMS) among sport climbers and to address the mechanisms of peripheral and central sensitization involved in DOMS phenomena. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Sensitization, Peripheral Nervous System Disorders, Muscle Soreness
- What is being tested?
- Soft tissue treatment, Mechaninsms explanation and Neurodynamic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Jan 2020to 30 Oct 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being explained all the associated risks and benefits of the research
- Sign the written informed consent
Who cannot join
- Significant neck or upper limbs pain (with Numeric Pain Rating Scale [NPRS] greater than 3/10)
- Pregnancy
- Recent neck or arm surgery or significant trauma in the preceding 3 months
- Cancer or inflammatory disorders,
- Spinal cord or cauda equina signs
- Widespread neurological disorders affecting the tone of upper limbs and neck muscles
- Underlying diseases, such as diabetes mellitus.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Biological and Clinical Science - University of Turin
Orbassano, TO, 10043
Centro Universitario Sportivo
Torino, TO, 10043
About this study
Official title: Peripheral vs Central Pain Modulation Mechanisms Involved in Delayed Onset Muscles Soreness in Sport Climbers a Randomized Trial
The aim of the present research is to define the effects of short manual treatment of soft tissues compared to mechanisms explaining in Delayed Onset Muscle Soreness (DOMS) among sport climbers and to address the mechanisms of peripheral and central sensitization involved in DOMS phenomena.
Read the detailed description
Sport climbing is a growing success sport that will be debuting as an official discipline in the Tokyo 2020 Olympics game. They are used during competitions.
To practice this discipline, both dexterity in movement and extreme physical strength are needed to climb the sloping and vertical walls that are used during competitions.
The appearance of muscle pain induced by an unusual and strenuous physical activity (DOMS) is an extremely common factor in all sports activities that involves a maximum and repeated muscular effort. In the sport climbing practice this physiological phenomenon is common and occurs both in those who practice at as professional and amateur level. Numerous studies have shown that muscle pain is induced by physical activity and independent of damage to muscle fibers and classic inflammation of tissues. The phenomenon of DOMS is accompanied by hyperalgesia and allodynia during muscle contraction, these are conditions of irritation of the peripheral nervous system (SNP) and central nervous system (CNS), but today no evidence of such sensitization phenomena of the SNP and SNC has been provided. The presence of muscle pain is one of the main causes of impossibility to practice sports not only for those who practice sport climbing at a professional level, but for most amateur sportsmen. Thanks to the tools validated in the last decade, it is possible to study the involvement and awareness responses of the SNP and SNC with reliable and non-invasive techniques in the phenomenon of DOMS. Understanding the mechanisms underlying the appearance of the DOMS is today a primary priority for sports practice and for physical training for muscular effort both as a professional and amateur level.
Presence of peripheral and central sensitization in DOMS will be assessed and a three arm randomized controlled double blind multicentric study will be performed to assess the effects of treatment on peripheral tissues compared to pain mechanisms explanation. Healthy participants of both sexes will be assessed before DOMS, at 48 hours (the peak phase of symptoms) before and after treatment and at 96 hours when symptoms usually are in remission.
- Conditions
- Central Nervous System Sensitization, Peripheral Nervous System Disorders, Muscle Soreness, Muscle Strength
- Being tested
- Soft tissue treatment, Mechaninsms explanation, Control Group, Neurodynamic treatment
- Keywords
- Sport climber, Delayed Onset Muscle Soreness, Central sensitization, Peripheral sensitization, Soft tissue treatment
- Medical subject headings
- Peripheral Nervous System Diseases, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue treatmentOther
Also called compression combined to longitudinal repeated mobilization of the forearm soft tissues
Participants will be asked to sit in front of a medical table with their forearms supinated and relaxed. 5 minutes of deep tissue manual flossing on the proximal and medial aspect of the forearm of each side will be administered by keeping the hands contact on the skin of the participants for all the treatment duration. Direction of the gentle repeated manual compressions and shifts will be proximal to distal or vicerversa depending on the symptom reduction reported by the participants. Stimuli frequencies will be about 0,2-03 Hz. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms
Mechaninsms explanationOther
Participants will be instructed with a 10 minutes lesson on mechanisms hypothesized to generate Delayed Onset Muscle Soreness. To trigger the most the bottom down pain modulation given by the placebo effect lesson will be concluded stressing the fact that DOMS have a good prognosis and that in a short amount of time they will be pain free and also that no drugs are effective to reduce pain intensity in DOMS condition suggesting them to stay physically active.
Control GroupOther
Participants will be asked to wait 10 minutes and to relax until the tests will be performed again.
Neurodynamic treatmentOther
Participants will be asked to lay supine on a medical table and keep their arms relaxed. 30 repetitions of gentle upper limb nerves mobilization, performed through a combination of neck and arm physiological movements, will be administered with cycles of tensions and relaxation of 1/5 seconds for 3 minutes in total for each arm. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue treatment | Experimental | Participants will be treated with 5 minutes of deep tissue manual flossing on the proximal and medial aspect of the forearm of each side. Direction of the gentle repeated manual compressions and shifts will be proximal to distal or vicerversa depending on the symptom reduction reported by the participants. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms. Receives: Other: Soft tissue treatment |
| Mechaninsms explanation | Placebo comparator | Participants will be instructed with a 10 minute lesson on mechanisms hypothesized to generate Delayed Onset Muscle Soreness. To trigger the most the bottom down pain modulation given by the placebo effect lesson will be concluded stressing the fact that DOMS have a good prognosis and that in a short amount of time they will be pain free and also that no drugs are effective to reduce pain intensity in DOMS condition suggesting them to stay physically active. Receives: Other: Mechaninsms explanation |
| Control group | Other | Participants will be asked to wait 10 minutes and to relax until the tests will be performed again. Receives: Other: Control Group |
| Neurodynamic treatment | Experimental | Participants will be asked to lay supine on a medical table and keep their arms relaxed. 30 repetitions of gentle upper limb nerves mobilization, performed through a combination of neck and arm physiological movements, will be administered with cycles of tensions and relaxation of 1/5 seconds for 3 minutes in total for each arm. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms Receives: Other: Neurodynamic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Numeric Pain Rating Scale at one week
pain intensity will be tested asking the standardized question " on a scale from 0 to 10 when 0 is no pain and 10 is the worst pain ever rate the pain intensity you feel in this moment in the body part assessed"
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from Baseline Mechanical allodynia at one week
The assessor thumb will be placed over the testing area and pressure will be applied for 10 s (Scholz et al., 2009). The pressure will be sufficient to indent the soft tissues and lead to skin blanching
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from Baseline Wind-Up at one week
10 nociceptive standardized stimuli will be administered on the skin of the painful area involved by muscle soreness on the medial aspect of the proximal forearm
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from Baseline Upper limb neurodynamic test at one week
The validated test to detect upper limb peripheral nervous system neuropathies involving physiological combined passive movements of the upper limb will be administered with the participant laying supine on a medical table.
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from basaeline Muscle endurance (flexor digiturum profundis and superficialis) test at one week
subjects will be required to keep their body weight lifted from the ground, hanging as much time as possible with their fingers on a standardized metal bar
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Secondary outcomes (6)
Change from Baseline Forearm circumference
using a standardized measuring tape circumference of the forearm at a standardized distance from the medial epicondylus will be recorded
Measured: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up as Likert scale
A validated self administered 11 point Likert scale whit "0 Much Better and 10 Much Worse" will be fulfilled by participants to assess the degree of change in participant painful condition induced from the treatment administered.
Measured: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up
It will be administered a validated categorical self administered scale of perceived improvement that inquires the pain intensity perceived changes induced by the treatment received:
"Since when did you start the treatment, can you describe your impression of how your painful condition has changed (limitation of physical activity, emotion and quality of life)?" No change, (or even worsened) Always the same, it is difficult to think of an improvement A little better, but not remarkable Sometimes better, but change isn't a real difference Moderately better, a slight and noticeable improvement Better, a decided improvement that constitutes a real difference A big and decisive improvement, and that makes the difference
Measured: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Change from Baseline Body Chart at one week
Symptoms will be reported topographically using a validated pain drawing tool to collect information on the symptom area and on their intensity and behaviour
Measured: The test will be administered before first training, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from Baseline Central Sensitization Inventory at 48 hours
A validated self administered inventory on the central sensitizing phenomenon will be administered. It briefly consists in a 25 item questionnaire that inquires the presence of symptoms related to central sensitization
Measured: The test will be administered at baseline and after 48 hours before treatment
Perceived Health Status
Perceived Health status will be tested using a 11 point Likert scale from 0 equal to the worts and 100 equal to the best perceived health status and subjects will be asked to report with an x their actual condition.
Measured: The test will be administered at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Jan 2020
- Primary completion22 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System SensitizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Carta, University of Turin, Italy
- Investigators
- Giacomo Carta, Msc, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255212
- Sponsor's protocol ID
- 437038-15102019
- Status last verified
- Nov 2022
- First submitted
- 30 Jan 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to share all data after publication of the research on a scientific journal
Publications
Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692Chiarotto A, Viti C, Sulli A, Cutolo M, Testa M, Piscitelli D. Cross-cultural adaptation and validity of the Italian version of the Central Sensitization Inventory. Musculoskelet Sci Pract. 2018 Oct;37:20-28. doi: 10.1016/j.msksp.2018.06.005. Epub 2018 Jun 15.
PubMed 29966856Egloff N, Klingler N, von Kanel R, Camara RJ, Curatolo M, Wegmann B, Marti E, Ferrari ML. Algometry with a clothes peg compared to an electronic pressure algometer: a randomized cross-sectional study in pain patients. BMC Musculoskelet Disord. 2011 Jul 25;12:174. doi: 10.1186/1471-2474-12-174.
PubMed 21787399Jensen TS, Finnerup NB. Allodynia and hyperalgesia in neuropathic pain: clinical manifestations and mechanisms. Lancet Neurol. 2014 Sep;13(9):924-35. doi: 10.1016/S1474-4422(14)70102-4.
PubMed 25142459Mizumura K, Taguchi T. Delayed onset muscle soreness: Involvement of neurotrophic factors. J Physiol Sci. 2016 Jan;66(1):43-52. doi: 10.1007/s12576-015-0397-0.
PubMed 26467448Paulsen G, Mikkelsen UR, Raastad T, Peake JM. Leucocytes, cytokines and satellite cells: what role do they play in muscle damage and regeneration following eccentric exercise? Exerc Immunol Rev. 2012;18:42-97.
PubMed 22876722
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral vs Central Pain Modulation Mechanisms Involved in Delayed Onset Muscles Soreness in Sport Climbers a Randomized Trial
- ClinicalTrials.gov ID
- NCT04255212
- Acronym / sponsor ID
- 437038-15102019
- Conditions
- Central Nervous System Sensitization, Peripheral Nervous System Disorders, Muscle Soreness, Muscle Strength
- Keywords
- Sport climber, Delayed Onset Muscle Soreness, Central sensitization, Peripheral sensitization, Soft tissue treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 5 Feb 2020 (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.
The aim of the present research is to define the effects of short manual treatment of soft tissues compared to mechanisms explaining in Delayed Onset Muscle Soreness (DOMS) among sport climbers and to address the mechanisms of peripheral and central sensitization involved in DOMS phenomena.
Detailed description
Sport climbing is a growing success sport that will be debuting as an official discipline in the Tokyo 2020 Olympics game. They are used during competitions.
To practice this discipline, both dexterity in movement and extreme physical strength are needed to climb the sloping and vertical walls that are used during competitions.
The appearance of muscle pain induced by an unusual and strenuous physical activity (DOMS) is an extremely common factor in all sports activities that involves a maximum and repeated muscular effort. In the sport climbing practice this physiological phenomenon is common and occurs both in those who practice at as professional and amateur level. Numerous studies have shown that muscle pain is induced by physical activity and independent of damage to muscle fibers and classic inflammation of tissues. The phenomenon of DOMS is accompanied by hyperalgesia and allodynia during muscle contraction, these are conditions of irritation of the peripheral nervous system (SNP) and central nervous system (CNS), but today no evidence of such sensitization phenomena of the SNP and SNC has been provided. The presence of muscle pain is one of the main causes of impossibility to practice sports not only for those who practice sport climbing at a professional level, but for most amateur sportsmen. Thanks to the tools validated in the last decade, it is possible to study the involvement and awareness responses of the SNP and SNC with reliable and non-invasive techniques in the phenomenon of DOMS. Understanding the mechanisms underlying the appearance of the DOMS is today a primary priority for sports practice and for physical training for muscular effort both as a professional and amateur level.
Presence of peripheral and central sensitization in DOMS will be assessed and a three arm randomized controlled double blind multicentric study will be performed to assess the effects of treatment on peripheral tissues compared to pain mechanisms explanation. Healthy participants of both sexes will be assessed before DOMS, at 48 hours (the peak phase of symptoms) before and after treatment and at 96 hours when symptoms usually are in remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Soft tissue treatment | Experimental | Other: Soft tissue treatmentParticipants will be treated with 5 minutes of deep tissue manual flossing on the proximal and medial aspect of the forearm of each side. Direction of the gentle repeated manual compressions and shifts will be proximal to distal or vicerversa depending on the symptom reduction reported by the participants. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms. |
| Mechaninsms explanation | Placebo comparator | Other: Mechaninsms explanationParticipants will be instructed with a 10 minute lesson on mechanisms hypothesized to generate Delayed Onset Muscle Soreness. To trigger the most the bottom down pain modulation given by the placebo effect lesson will be concluded stressing the fact that DOMS have a good prognosis and that in a short amount of time they will be pain free and also that no drugs are effective to reduce pain intensity in DOMS condition suggesting them to stay physically active. |
| Control group | Other | Other: Control GroupParticipants will be asked to wait 10 minutes and to relax until the tests will be performed again. |
| Neurodynamic treatment | Experimental | Other: Neurodynamic treatmentParticipants will be asked to lay supine on a medical table and keep their arms relaxed. 30 repetitions of gentle upper limb nerves mobilization, performed through a combination of neck and arm physiological movements, will be administered with cycles of tensions and relaxation of 1/5 seconds for 3 minutes in total for each arm. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being explained all the associated risks and benefits of the research
- Sign the written informed consent
Key exclusion criteria (7 listed)
- Significant neck or upper limbs pain (with Numeric Pain Rating Scale [NPRS] greater than 3/10)
- Pregnancy
- Recent neck or arm surgery or significant trauma in the preceding 3 months
- Cancer or inflammatory disorders,
- Spinal cord or cauda equina signs
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 |
|---|---|---|
| Soft tissue treatmentAlso: compression combined to longitudinal repeated mobilization of the forearm soft tissuesParticipants will be asked to sit in front of a medical table with their forearms supinated and relaxed. 5 minutes of deep tissue manual flossing on the proximal and medial aspect of the forearm of each side will be administered by keeping the hands contact on the skin of the participants for all the treatment duration. Direction of the gentle repeated manual compressions and shifts will be proximal to distal or vicerversa depending on the symptom reduction reported by the participants. Stimuli frequencies will be about 0,2-03 Hz. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms | Other | Soft tissue treatment |
| Mechaninsms explanationParticipants will be instructed with a 10 minutes lesson on mechanisms hypothesized to generate Delayed Onset Muscle Soreness. To trigger the most the bottom down pain modulation given by the placebo effect lesson will be concluded stressing the fact that DOMS have a good prognosis and that in a short amount of time they will be pain free and also that no drugs are effective to reduce pain intensity in DOMS condition suggesting them to stay physically active. | Other | Mechaninsms explanation |
| Control GroupParticipants will be asked to wait 10 minutes and to relax until the tests will be performed again. | Other | Control group |
| Neurodynamic treatmentParticipants will be asked to lay supine on a medical table and keep their arms relaxed. 30 repetitions of gentle upper limb nerves mobilization, performed through a combination of neck and arm physiological movements, will be administered with cycles of tensions and relaxation of 1/5 seconds for 3 minutes in total for each arm. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms | Other | Neurodynamic treatment |
Primary outcome
Change from Baseline Numeric Pain Rating Scale at one week
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
pain intensity will be tested asking the standardized question " on a scale from 0 to 10 when 0 is no pain and 10 is the worst pain ever rate the pain intensity you feel in this moment in the body part assessed"
Change from Baseline Mechanical allodynia at one week
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
The assessor thumb will be placed over the testing area and pressure will be applied for 10 s (Scholz et al., 2009). The pressure will be sufficient to indent the soft tissues and lead to skin blanching
Change from Baseline Wind-Up at one week
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
10 nociceptive standardized stimuli will be administered on the skin of the painful area involved by muscle soreness on the medial aspect of the proximal forearm
Change from Baseline Upper limb neurodynamic test at one week
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
The validated test to detect upper limb peripheral nervous system neuropathies involving physiological combined passive movements of the upper limb will be administered with the participant laying supine on a medical table.
Change from basaeline Muscle endurance (flexor digiturum profundis and superficialis) test at one week
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
subjects will be required to keep their body weight lifted from the ground, hanging as much time as possible with their fingers on a standardized metal bar
6 secondary outcomes
Change from Baseline Forearm circumference
Time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up as Likert scale
Time frame: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up
Time frame: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Change from Baseline Body Chart at one week
Time frame: The test will be administered before first training, at 48 hours before and after treatment administration, and at 96 hours from baseline
Change from Baseline Central Sensitization Inventory at 48 hours
Time frame: The test will be administered at baseline and after 48 hours before treatment
Perceived Health Status
Time frame: The test will be administered at baseline
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 3 Nov 2022.
- Background: PubMed 12617692Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- Background: PubMed 29966856Chiarotto A, Viti C, Sulli A, Cutolo M, Testa M, Piscitelli D. Cross-cultural adaptation and validity of the Italian version of the Central Sensitization Inventory. Musculoskelet Sci Pract. 2018 Oct;37:20-28. doi: 10.1016/j.msksp.2018.06.005. Epub 2018 Jun 15.
- Background: PubMed 21787399Egloff N, Klingler N, von Kanel R, Camara RJ, Curatolo M, Wegmann B, Marti E, Ferrari ML. Algometry with a clothes peg compared to an electronic pressure algometer: a randomized cross-sectional study in pain patients. BMC Musculoskelet Disord. 2011 Jul 25;12:174. doi: 10.1186/1471-2474-12-174.
- Background: PubMed 25142459Jensen TS, Finnerup NB. Allodynia and hyperalgesia in neuropathic pain: clinical manifestations and mechanisms. Lancet Neurol. 2014 Sep;13(9):924-35. doi: 10.1016/S1474-4422(14)70102-4.
- Background: PubMed 26467448Mizumura K, Taguchi T. Delayed onset muscle soreness: Involvement of neurotrophic factors. J Physiol Sci. 2016 Jan;66(1):43-52. doi: 10.1007/s12576-015-0397-0.
- Background: PubMed 22876722Paulsen G, Mikkelsen UR, Raastad T, Peake JM. Leucocytes, cytokines and satellite cells: what role do they play in muscle damage and regeneration following eccentric exercise? Exerc Immunol Rev. 2012;18:42-97.
- Individual participant dataSharing planned: Yes. We intend to share all data after publication of the research on a scientific journal
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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.
Giacomo Carta, Msc principal investigator
University of Turin, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue treatment, Mechaninsms explanation and Neurodynamic treatment in people with Central Nervous System Sensitization and Peripheral Nervous System Disorders, run by University of Turin, Italy at 2 sites in Italy.
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 2 inclusion and 7 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Numeric Pain Rating Scale at one week (time frame: The test will be administered at baseline, before the first climbing training session, at 48 hours before and after treatment administration, and at 96 hours from baseline). The study lists 5 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 NCT04255212, which also lists 6 linked publications.
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 3 Nov 2022.