Clinical trial NCT04255212: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Numeric Pain Rating Scale at one week
timeFrame: 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
measure: Change from Baseline Mechanical allodynia at one week
timeFrame: 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
measure: Change from Baseline Wind-Up at one week
timeFrame: 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
measure: Change from Baseline Upper limb neurodynamic test at one week
timeFrame: 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
measure: Change from basaeline Muscle endurance (flexor digiturum profundis and superficialis) test at one week
timeFrame: 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:
measure: Change from Baseline Forearm circumference
timeFrame: 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
measure: Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up as Likert scale
timeFrame: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
measure: Change from post treatment Perceived Reported Outcome Measure at 48 hours follow-up
timeFrame: The test will be administered after treatment at 48 hours from baseline and at 96 hours from baseline
measure: Change from Baseline Body Chart at one week
timeFrame: The test will be administered before first training, at 48 hours before and after treatment administration, and at 96 hours from baseline
measure: Change from Baseline Central Sensitization Inventory at 48 hours
timeFrame: The test will be administered at baseline and after 48 hours before treatment
measure: Perceived Health Status
timeFrame: The test will be administered at baseline
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: Department of Biological and Clinical Science - University of Turin
state: TO
city: Torino
country: Italy
facility: Centro Universitario Sportivo
state: TO
Study officials:
affiliation: University of Turin, Italy
name: Giacomo Carta, Msc
role: PRINCIPAL_INVESTIGATOR
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