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Effects of Soft Tissue Treatment vs Mechanisms Explanation to Treat Delayed Onset Muscles Soreness Among Sport Climbers

Primary Purpose

Central Nervous System Sensitization, Peripheral Nervous System Disorders, Muscle Soreness

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Soft tissue treatment
Mechaninsms explanation
Control Group
Neurodynamic treatment
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Sensitization focused on measuring Sport climber, Delayed Onset Muscle Soreness, Central sensitization, Peripheral sensitization, Soft tissue treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being explained all the associated risks and benefits of the research
  • Sign the written informed consent

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Biological and Clinical Science - University of Turin
  • Centro Universitario Sportivo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Other

Experimental

Arm Label

Soft tissue treatment

Mechaninsms explanation

Control group

Neurodynamic treatment

Arm Description

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.

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.

Participants will be asked to wait 10 minutes and to relax until the tests will be performed again.

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

Outcomes

Primary Outcome Measures

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"
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
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
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.
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

Secondary Outcome Measures

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
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.
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
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
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
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.

Full Information

First Posted
January 30, 2020
Last Updated
November 2, 2022
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT04255212
Brief Title
Effects of Soft Tissue Treatment vs Mechanisms Explanation to Treat Delayed Onset Muscles Soreness Among Sport Climbers
Official Title
Peripheral vs Central Pain Modulation Mechanisms Involved in Delayed Onset Muscles Soreness in Sport Climbers a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
October 22, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are blinded to their allocation that will not be communicated till the conclusion of the research. The outcome assessors are blinded to the allocation of the participants
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Mechaninsms explanation
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Participants will be asked to wait 10 minutes and to relax until the tests will be performed again.
Arm Title
Neurodynamic treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Soft tissue treatment
Other Intervention Name(s)
compression combined to longitudinal repeated mobilization of the forearm soft tissues
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Mechaninsms explanation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Participants will be asked to wait 10 minutes and to relax until the tests will be performed again.
Intervention Type
Other
Intervention Name(s)
Neurodynamic treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline Numeric Pain Rating Scale at one week
Description
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"
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
Title
Change from Baseline Mechanical allodynia at one week
Description
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
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
Title
Change from Baseline Wind-Up at one week
Description
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
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
Title
Change from Baseline Upper limb neurodynamic test at one week
Description
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.
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
Title
Change from basaeline Muscle endurance (flexor digiturum profundis and superficialis) test at one week
Description
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
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
Secondary Outcome Measure Information:
Title
Change from Baseline Forearm circumference
Description
using a standardized measuring tape circumference of the forearm at a standardized distance from the medial epicondylus will be recorded
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
Title
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up as Likert scale
Description
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.
Time Frame
The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Title
Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up
Description
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
Time Frame
The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
Title
Change from Baseline Body Chart at one week
Description
Symptoms will be reported topographically using a validated pain drawing tool to collect information on the symptom area and on their intensity and behaviour
Time Frame
The test will be administered before first training, at 48 hours before and after treatment administration, and at 96 hours from baseline
Title
Change from Baseline Central Sensitization Inventory at 48 hours
Description
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
Time Frame
The test will be administered at baseline and after 48 hours before treatment
Title
Perceived Health Status
Description
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.
Time Frame
The test will be administered at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being explained all the associated risks and benefits of the research Sign the written informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomo Carta, Msc
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biological and Clinical Science - University of Turin
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Centro Universitario Sportivo
City
Torino
State/Province
TO
ZIP/Postal Code
10043
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We intend to share all data after publication of the research on a scientific journal
IPD Sharing Time Frame
Immediatelly after scientific paper publication all data will be shared
IPD Sharing Access Criteria
Data will be avaliable Online at the URL reported above
Citations:
PubMed Identifier
12617692
Citation
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.
Results Reference
background
PubMed Identifier
29966856
Citation
Chiarotto 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.
Results Reference
background
PubMed Identifier
21787399
Citation
Egloff 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.
Results Reference
background
PubMed Identifier
25142459
Citation
Jensen 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.
Results Reference
background
PubMed Identifier
26467448
Citation
Mizumura 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.
Results Reference
background
PubMed Identifier
22876722
Citation
Paulsen 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.
Results Reference
background

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Effects of Soft Tissue Treatment vs Mechanisms Explanation to Treat Delayed Onset Muscles Soreness Among Sport Climbers

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