Central Sensitisation Clinical Trial
Official title:
Evaluation of the Segmental Distribution of Pain Hypersensitivity Among Patients With Central Sensitization Associated With Chronic Subacromial Pain Syndrome
NCT number | NCT06139120 |
Other study ID # | 125/14 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 20, 2022 |
Est. completion date | December 30, 2022 |
Verified date | November 2023 |
Source | Cukurova University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This study aimed to determine the distribution of pain sensitivity according to body segments in patients with central sensitization associated with chronic subacromial pain syndrome (SPS).This cross-sectional study included patients with chronic SPS and central sensitization (patient group) and the same number of healthy participants as controls. The presence of central sensitization was determined using the Central Sensitization Inventory. To determine the segmental distribution of pain sensitivity, pressure pain threshold measurements were performed bilaterally from the shoulder, forearm, and leg.
Status | Completed |
Enrollment | 116 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - To be diagnosed with chronic (= 3 months) unilateral SPS according to clinical examination (the Hawkins-Kennedy test and the painful arc test) and/or imaging. - To be scored = 40 on CSI Exclusion Criteria: i) Bilateral shoulder pain syndrome, ii) History ofshoulder surgery, iii) Osteoarthritis of the glenohumeral joint on direct radiography, v)concomitant diseases with the potential risk of development of central/peripheral sensitization [diseases specified in CSI part B, vi) symptomatic lateral/central spinal stenosis, myelopathy, or radiculopathy, vii) history of centrally acting drug use (e.g.,pregabalin, gabapentin, amitriptyline, duloxetine, and opioid) viii) alcohol/substance abuse. |
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University | Adana |
Lead Sponsor | Collaborator |
---|---|
Cukurova University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure pain threshold (PPT) measurement | PPT is the lowest amount of pressure at which pain is felt. The current study used a manual algometer (Force Dial FDK 20, Wagner, Greenwich, USA) with a rubber tip and a surface area of 1 cm2 for PPT measurements. The measurements were performed bilaterally from the shoulder (midpoint of deltoid muscle), forearm (midpoint of brachioradialis muscle), and leg (midpoint of tibialis anterior muscle). | Baseline | |
Primary | Central sensitization inventory (CSI) | The CSI was used to determine the presence of central sensitization in the participants. The CSI contains 25 items related to central sensitization symptoms scored on a four-point Likert scale, with the total score ranging from 0 to 100. A cutoff score of 40 or greatest indicates the presence of central sensitization. | Baseline |
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