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

NCT04255212 | Completed

• 1 other identifier: 437038-15102019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• 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"

  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

  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

  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.

  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

  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

  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

Study Arms (4)

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.

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.

Other: Mechaninsms explanation

Control group

OTHER

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

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

Other: Neurodynamic treatment

Interventions

Soft tissue treatment OTHER

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

Also known as: compression combined to longitudinal repeated mobilization of the forearm soft tissues

Soft tissue treatment

Mechaninsms explanation OTHER

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.

Mechaninsms explanation

Control Group OTHER

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

Control group

Neurodynamic treatment OTHER

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

Neurodynamic treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (2)

Department of Biological and Clinical Science - University of Turin

Orbassano, TO, 10043, Italy

Location

Centro Universitario Sportivo

Torino, TO, 10043, Italy

Location

Related Publications (6)

• 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.

  PMID: 12617692 BACKGROUND

• 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.

  PMID: 29966856 BACKGROUND

• 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.

  PMID: 21787399 BACKGROUND

• 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.

  PMID: 25142459 BACKGROUND

• 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.

  PMID: 26467448 BACKGROUND

• 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.

  PMID: 22876722 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Myalgia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Giacomo Carta, Msc

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Randomized trial

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 13, 2020
• Primary Completion: October 22, 2022
• Study Completion: October 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediatelly after scientific paper publication all data will be shared
• Access Criteria: Data will be avaliable Online at the URL reported above

Locations

IT (2)