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Clinical Trials/NCT04255212
NCT04255212
Completed
N/A

Peripheral vs Central Pain Modulation Mechanisms Involved in Delayed Onset Muscles Soreness in Sport Climbers a Randomized Trial

University of Turin, Italy2 sites in 1 country120 target enrollmentJanuary 13, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Central Nervous System Sensitization
Sponsor
University of Turin, Italy
Enrollment
120
Locations
2
Primary Endpoint
Change from Baseline Numeric Pain Rating Scale at one week
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2020
End Date
October 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Giacomo Carta

Principal Investigator, Clinical Professor

University of Turin, Italy

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from Baseline Forearm circumference(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(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(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(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(The test will be administered at baseline and after 48 hours before treatment)
  • Perceived Health Status(The test will be administered at baseline)

Study Sites (2)

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