Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05524870
Other study ID # 107/82
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date February 5, 2023

Study information

Verified date November 2023
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways. However, there is no evidence of this mechanism available yet. Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date February 5, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests), - To have <40 score in central sensitization inventory. Exclusion Criteria: - To have bilateral subacromial pain, - To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B) - To have severe osteoarthritis or subluxation in shoulder joint, - To have adhesive capsulitis, - Being treated with physiotherapy for this disorder at least one month before the start of the study. - To have severe cervical or lumbar radiculopathy,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobilization
Movement with mobilization plus exercise

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Central Sensitization Inventory The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization. The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100. Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization. A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization. Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
Primary Pressure-Pain Threshold-Algometer Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. A mechanical pressure algometer is used in this study to assess PPT. This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter. The range of the algometer is 0 to 10 kg with 0.1-kg divisions. Higher scores indicate high PPT. Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
Secondary Quick Disabilities of the Shoulder, Arm and Hand Questionnaire The Quick Disabilities of the Shoulder, Arm and Hand Questionnaire assesses physical functioning and symptoms of the upper limb, yielding a result between 0 and 100% (0% being the best and 100% being the worst outcomes). Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.
See also
  Status Clinical Trial Phase
Completed NCT06139120 - The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome
Completed NCT05062694 - Physical Therapy Management Of The Patient With Central Sensitization
Not yet recruiting NCT05986513 - Brain MRI for Knee OA N/A
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Completed NCT05559021 - What Concept of Manual Therapy is More Effective? N/A
Completed NCT04485078 - Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
Completed NCT05162664 - Presence of Signs of Central Sensitization in Episodic and Chronic Migraine N/A
Recruiting NCT06043141 - Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome
Completed NCT06336278 - Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis
Terminated NCT05022251 - Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Completed NCT04361149 - Motor Unit Abnormalities After Experimentally Induced Sensitization Phase 4
Completed NCT05146960 - Relation Between Temporal Summation and Fatigue N/A
Completed NCT04043962 - Mechanisms Of Change in Adolescent Pain Self-management N/A
Completed NCT03863808 - Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization N/A
Active, not recruiting NCT05169918 - Sensorial Discrimination in Chronic Low Back Pain N/A
Completed NCT03531385 - Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease
Recruiting NCT06169917 - Pain Processing In Relation To Breathing N/A
Not yet recruiting NCT06367998 - Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT05932433 - Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients. N/A
Completed NCT05381012 - Fibromyalgia Syndrome on Patients With Chronic Migraine N/A