Sensory Processing and Musculoskeletal Shoulder Pain

NCT05368649 | Completed

• 1 other identifier: UGranRosario
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The development of chronic pain is a common complication in shoulder pain conditions. Half of these type of patients exhibit persistent pain even after a period of six to twelve months from the start of their pain treatment. Persistent pain is most likely a result of different biological alterations, including but not limited to tissue damage. Another potential cause is neurogenic inflammation, which can be triggered by applying excessive mechanical stress to a structure or region. Neurogenic inflammation can lead to peripheral sensitization and sensitizing the musculoskeletal tissues in the process, and this sensitization will last until the input is removed. Nevertheless, even though peripheral factors are sufficient to perpetuate pain, the role of central mechanisms cannot be excluded as a potential cause of sensitization. Moreover, the evidence is not conclusive about deficiencies in pain modulation processes and presence of central mechanisms in chronic pain conditions. It is well known that chronic shoulder pain presents a multi-factorial nature. Hypersensitivity in this condition has been linked to persistent activation of peripheral nerves, which can result in an increased excitability of the sensory input and reduced inhibitory effect of pain modulatory mechanisms. On the other hand, the role the central sensitization plays is not completely clear in this type of patients, but could also contribute to the hypersensitivity in some patients.However, it has been shown that there is a remarkable variability in the presence of central effects among chronic patients. The aim of this study is to evaluate changes in sensory processing and in pain modulatory mechanisms in individuals with and without shoulder pain.

Conditions

Shoulder Pain; Healthy Volunteers

Keywords

Shoulder pain; Infraspinatus muscle; Muscle pain; Generalized hypersensitivity; Pressure algometry; Conditioned pain modulation

Outcome Measures

Primary Outcomes (2)

• Conditioned pain modulation (CPM)

  CPM will be assessed by immersing the hand up to the wrist in a cold water bath (0.6-0.8°) with a circulating water pump. The dominant arm for healthy and the symptomatic side for unilateral shoulder pain volunteers will be immerse in the cold-water bath. In general, the conditioning stimulus will be applied for 2 min or maximum tolerance (whichever comes first). A computerized, custom-made visual analog scale (VAS) will be used to continuously track the response profile to conditional stimuli across participants during the application of CPM. A numeric rating scale ranging from 0 to 100, where 0 represents no perception, 30 represents pain threshold (defined as the time to reach a painful sensation at the predefined stimulation intensity) and 100 represents the tolerance threshold (defined as the sensation of pain when becomes intolerable). Before and immediately after the immersion, PPT measurements will be assessed on both infraspinatus muscles.

  At baseline and immediately after the cold-water immersion in the first session.

• Pressure pain threshold (PPT)

  Change in the PPT (kPa) will be assessed bilaterally over the medial portion of the infraspinatus muscle using a digital algometer (Somedic SenseLab AB, Sweden) with a 1-cm2 round tip. Pressure will be gradually increased from 0 kPa at a rate of approximately 50 kPa/s (maximal achievable pressure: 2,000 kPa). The volunteers will be asked to press the button when they perceive that the pressure changes to pain, stopping the estimation at this point. The assessment will be repeated 3 times for each sides, alternating sides between measurements. Each measure will be performed at 30-second intervals.

  At baseline and 30 - 60 minutes after the short-wave diathermia in the second session.

Secondary Outcomes (9)

• Thermal sensitivity thresholds

  At baseline in the first session.

• Pain intensity

  At baseline in the first session.

• Shoulder joint position sensation

  At baseline in the first session.

• Myoelectrical activity (EMG)

  At 10 minutes before and 30 - 60 minutes after the application of SWD for control in the second session.

• Pain distribution

  At 15 - 30 minutes before recording of muscle activity for chronic patients and 30 - 60 minutes after the application of SWD for control in the second session.

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Short-wave diathermy

Other: Short-wave diathermy

Shoulder Pain

NO INTERVENTION

Volunteers with unilateral shoulder pain

Interventions

Short-wave diathermy OTHER

The SWD will be applied using a CEC M-8 shortwave thermotherapy unit (CEC Electrónica S.R.L., Argentina) that emits RF at a frequency of 27.12 MHz. The device has two rectangular capacitive applicators (18 × 12 cm), which will be placed below and above the dominant shoulder. The coplanar application will be done using the continuous wave mode. The intensity of SWD will be gradually increased until the volunteer perceives a sensation of heat, and once familiar with this perception, the intensity will be increased until a sensation of constant but tolerable pain is evoked. This sensation will be maintained throughout the SWD application, and three repetitions will be performed. Healthy volunteers will be in a lateral supine position, and a cotton towel will be used to absorb perspiration and avoid unwanted heat effects.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers with unilateral shoulder pain and mechanosensitivity in the infraspinatus muscle
• pain lasting more than 6 weeks
• Healthy volunteers

You may not qualify if:

• Previous surgery/trauma in the upper limb
• Previous physiotherapy treatments in the shoulder
• Pain intensity ≤ 2 and \> 9 (VAS)
• History of neurologic disorders
• Systemic disorders
• Cervical spine injuries or postural deformities
• Cortisone injections within the last 6 months
• Unusually strenuous activity 48 h before the testing session
• Glenohumeral instability
• Articular Hyperlaxitude (Beighton \> 4)

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Related Publications (1)

• Mista CA, Laugero SJ, Adur JF, Andersen OK, Biurrun Manresa JA. A new experimental model of muscle pain in humans based on short-wave diathermy. Eur J Pain. 2019 Oct;23(9):1733-1742. doi: 10.1002/ejp.1449. Epub 2019 Jul 24.

  PMID: 31251430 RESULT

MeSH Terms

Conditions

Shoulder Pain; Myalgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PPT measurements and data analysis will be conducted by assessors blind to group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the University Center for Assistance, Teaching and Research

Model Details: This is a case-control study in which the control (healthy volunteers) will receive an intervention (SWD).

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 10, 2022
• Study Start: April 1, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: From first date of publication of journal article.
• Access Criteria: IPD will be provided upon request.

Locations

AR (1)