Rotator Cuff LesionNCT06404125
Investigation of the Effect of Central Sensitization Symptom Severity on Steroid Injection Results in Shoulder Pain
An observational study of Rotator Cuff Lesion and Subacromial Impingement Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of the presence and severity of pre-treatment central sensitization on the results of subacromial/ intra-articular shoulder injection in patients with rotator cuff lesion/subacromial impingement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Lesion, Subacromial Impingement Syndrome, Shoulder Pain
- What is being tested?
- Range of Motion of Shoulde Joint, Hand Grip Test and Numeric Rating Scale
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rotator cuff lesion patients aged between 18-65 years old, who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection visiting our physical medicine and rehabilitation outpatient clinic between March 2023 and June 2024.
Who may be able to join
- Clinically and radiographically confirmed rotator cuff pathology
- Being between the ages of 18-65
- Non-response to medical treatment
- Being literate
- To agree to participate in the study
Who cannot join
- History of shoulder trauma and previous shoulder surgery
- Injection in the shoulder area in the last 3 months
- History of active cancer, systemic inflammatory disease and infection
- Pregnancy
- Under 18 and over 65 years of age
- Illiteracy
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Üsküdar, 34674
About this study
Official title: Investigation of the Effect of Pre-treatment Central Sensitization Severity on Steroid Injection Results in Rotator Cuff-induced Shoulder Pain
The aim of this study was to investigate the effect of the presence and severity of pre-treatment central sensitization on the results of subacromial/ intra-articular shoulder injection in patients with rotator cuff lesion/subacromial impingement. The hypothesis of the study is that the treatment response will decrease in patients with pre-injection central sensitization.
There are many studies investigating the frequency of central sensitization in various shoulder pathologies. However, the effect of this condition, which is likely to be associated with chronic pain in these patients, on treatment response is unknown. The effect on the results of shoulder injection, one of the most common procedures in physical therapy practice, will be investigated.
Read the detailed description
Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. Although some of the patients with shoulder pain show complete recovery, pain persists in some of them. One of the most common sources of pain in these patients is subacromial impingement syndrome (SIS) leading to rotator cuff pathology. The multifactorial nature of pain in these patients makes the treatment of SIS difficult.
Central sensitization (CS) has been reported as one of the factors associated with persistence of pain in patients with shoulder pain in different etiologies, especially in the SIS. CS can be summarized as an increase in the response of neurons located in the central nervous system to subthreshold stimuli and is the source of chronic pain in many diseases. A decrease in the pressure pain threshold was observed in the painful shoulder of 58 patients with experimental pain response in the shoulder.
In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, while SS was found in 11-24% of patients. The authors emphasized the significant correlation of CS with poor treatment response. There is increasing evidence that CS negatively affects various pain treatment responses, including surgery. Considering the frequency of CS in patients with shoulder pain, it is likely to have a negative impact on treatment response in these patients as well. One of the most common treatments for SIS is subacromial/ intra-articular shoulder injection. Although several factors have been identified in the prediction of shoulder injection outcomes, the effect of pain sensitization on these procedures is not yet known.
This study was designed as a prospective single-center study. Patients aged 18-65 years with rotator cuff lesions lasting more than three months and presenting to our physical medicine and rehabilitation outpatient clinic will be included. Patients who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection. Injection preference will be determined according to the patient primary complaint and lesion and will be administered into the subacromial space or into the shoulder joint. There is no additional interventional procedure due to the study. Patients will be divided into 2 groups with and without central sensitization. A total of 18 patients were planned for each group. The study will be conducted between March 2023 and June 2024.
Within the scope of the study, age, gender, body mass index, marital status, education level and occupation of the participants will be recorded as demographic data. Clinical evaluation includes pain duration, treatments received, pain intensity (numeric pain scale 0-10), disease-related MRI/USG findings and the following evaluations.
All patients will be evaluated before injection, 1 week, 1 and 3 months after injection. Within the scope of evaluation, Central Sensitization Scale, Quick DASH, SF-36 and Hospital Anxiety and Depression questionnaire, pressure pain threshold, goniometric shoulder range of motion measurement, hand grip strength (with Jamar hydraulic hand dynamometer), numeric pain scale (no pain: 0- unbearable pain: 10) and pain intensity will be recorded at each visit.
Data analysis will be performed by using the Statistical Package for the Social Sciences (SPSS, version 23.0, IBM Corp., Armonk, NY, USA).
- Being tested
- Range of Motion of Shoulde Joint, Hand Grip Test, Numeric Rating Scale, Pain-Pressure Threshold Measurement With an Algometer, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
- Keywords
- central sensitization, chronic pain, Subacromial, Shoulder, Pressure
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Range of Motion of Shoulde JointDiagnostic test
Goniometric measurements will be made for both upper extremities. Flexion, extension, abduction, adduction, internal and external rotation angles of the shoulder complex will be evaluated in the measurement.
Hand Grip TestDiagnostic test
The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 10 seconds. The test will be repeated for both upper extremities separately.
Numeric Rating ScaleDiagnostic test
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
Pain-Pressure Threshold Measurement With an AlgometerDiagnostic test
The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain.
The measurement includes bilateral shoulder region and left forearm as control region and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be:
- Bilateral supraspinatus muscle: 1 cm cranial to the midpoint of the spina scapulae
- Bilateral infraspinatus muscle: Medial edge of the scapula, intersection of the spina scapula and the inferior scapular angle
- Bilateral upper trapezius muscle: MidN point of the line joining the acromion and C7 spinous process
- Left forearm volar face center as control point
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)Diagnostic test
The arm, shoulder and hand problems rapid questionnaire is a shortened version of a questionnaire designed to detect symptoms and loss of function secondary to musculoskeletal problems of the upper extremity. The questionnaire will be used to assess quality of life related to upper extremity function.
Short Form-36Diagnostic test
The scale was developed by Ware in 1987 and consists of 36 questions in which 8 sub-parameters related to the health status of the person are questioned. These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. The Turkish validity and reliability of the scale was performed by Pınar et al. It is one of the leading methods used in the evaluation of quality of life in our country as well as all over the world.
Central Sensitization ScaleDiagnostic test
The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain.
Hospital Anxiety and Depression ScaleDiagnostic test
This scale was developed by Zigmond and Snaith in 1983 to screen anxiety and depression in individuals with physical illness. The scale consists of fourteen questions, seven for anxiety and seven for depression, to be answered on a four-point Likert scale. The Turkish validity and reliability of the scale has been demonstrated and a score above ten for anxiety and seven for depression is considered significant.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Patients without central sensitization) | Patients with rotator cuff lesions lasting more than three months and without central sensitization will be included in group 1. (n=18) Receives: Diagnostic Test: Range of Motion of Shoulde Joint; Diagnostic Test: Hand Grip Test; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer; Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH); Diagnostic Test: Short Form-36; Diagnostic Test: Central Sensitization Scale; Diagnostic Test: Hospital Anxiety and Depression Scale | |
| Group 2 (Patients with central sensitization) | patients with rotator cuff lesions lasting more than three months and central sensitization will be included in group 2. (n=18) Receives: Diagnostic Test: Range of Motion of Shoulde Joint; Diagnostic Test: Hand Grip Test; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer; Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH); Diagnostic Test: Short Form-36; Diagnostic Test: Central Sensitization Scale; Diagnostic Test: Hospital Anxiety and Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Scale
The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain.
Measured: 12 months
Secondary outcomes (7)
Range of Motion of Shoulde Joint
Goniometric measurements will be made for both upper extremities. Flexion, extension, abduction, adduction, internal and external rotation angles of the shoulder complex will be evaluated in the measurement.
Measured: 12 months
Hand Grip Test
The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 10 seconds. The test will be repeated for both upper extremities separately.
Measured: 12 months
Numeric Rating Scale
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
Measured: 12 months
Pain-Pressure Threshold Measurement With an Algometer
The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain. The measurement includes bilateral shoulder region and left forearm as control region and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be: 1. Bilateral supraspinatus muscle: 1 cm cranial to the midpoint of the spina scapulae 2. Bilateral infraspinatus muscle: Medial edge of the scapula, intersection of the spina scapula and the inferior scapular angle 3. Bilateral upper trapezius muscle: MidN point of the line joining the acromion and C7 spinous process 4. Left forearm volar face center as control point
Measured: 12 months
Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
The arm, shoulder and hand problems rapid questionnaire is a shortened version of a questionnaire designed to detect symptoms and loss of function secondary to musculoskeletal problems of the upper extremity. The questionnaire will be used to assess quality of life related to upper extremity function.
Measured: 12 months
Short Form-36
The scale was developed by Ware in 1987 and consists of 36 questions in which 8 sub-parameters related to the health status of the person are questioned. These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. The Turkish validity and reliability of the scale was performed by Pınar et al. It is one of the leading methods used in the evaluation of quality of life in our country as well as all over the world.
Measured: 12 months
Hospital Anxiety and Depression Scale
This scale was developed by Zigmond and Snaith in 1983 to screen anxiety and depression in individuals with physical illness. The scale consists of fourteen questions, seven for anxiety and seven for depression, to be answered on a four-point Likert scale. The Turkish validity and reliability of the scale has been demonstrated and a score above ten for anxiety and seven for depression is considered significant.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Mar 2023
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre Ata, Ass. Prof., Principal investigator, Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404125
- Sponsor's protocol ID
- 23/20
- Status last verified
- Sep 2025
- First submitted
- 3 May 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
PubMed 35382371Walankar PP, Panhale VP, Patil MM. Psychosocial factors, disability and quality of life in chronic shoulder pain patients with central sensitization. Health Psychol Res. 2020 Oct 1;8(2):8874. doi: 10.4081/hpr.2020.8874. eCollection 2020 Oct 5.
PubMed 33123644Previtali D, Bordoni V, Filardo G, Marchettini P, Guerra E, Candrian C. High Rate of Pain Sensitization in Musculoskeletal Shoulder Diseases: A Systematic Review and Meta-analysis. Clin J Pain. 2021 Mar 1;37(3):237-248. doi: 10.1097/AJP.0000000000000914.
PubMed 33399396Coronado RA, Simon CB, Valencia C, George SZ. Experimental pain responses support peripheral and central sensitization in patients with unilateral shoulder pain. Clin J Pain. 2014 Feb;30(2):143-51. doi: 10.1097/AJP.0b013e318287a2a4.
PubMed 23619203Sanchis MN, Lluch E, Nijs J, Struyf F, Kangasperko M. The role of central sensitization in shoulder pain: A systematic literature review. Semin Arthritis Rheum. 2015 Jun;44(6):710-6. doi: 10.1016/j.semarthrit.2014.11.002. Epub 2014 Nov 13.
PubMed 25523242
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Pre-treatment Central Sensitization Severity on Steroid Injection Results in Rotator Cuff-induced Shoulder Pain
- ClinicalTrials.gov ID
- NCT06404125
- Acronym / sponsor ID
- 23/20
- Keywords
- central sensitization, chronic pain, Subacromial, Shoulder, Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the effect of the presence and severity of pre-treatment central sensitization on the results of subacromial/ intra-articular shoulder injection in patients with rotator cuff lesion/subacromial impingement. The hypothesis of the study is that the treatment response will decrease in patients with pre-injection central sensitization.
There are many studies investigating the frequency of central sensitization in various shoulder pathologies. However, the effect of this condition, which is likely to be associated with chronic pain in these patients, on treatment response is unknown. The effect on the results of shoulder injection, one of the most common procedures in physical therapy practice, will be investigated.
Detailed description
Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. Although some of the patients with shoulder pain show complete recovery, pain persists in some of them. One of the most common sources of pain in these patients is subacromial impingement syndrome (SIS) leading to rotator cuff pathology. The multifactorial nature of pain in these patients makes the treatment of SIS difficult.
Central sensitization (CS) has been reported as one of the factors associated with persistence of pain in patients with shoulder pain in different etiologies, especially in the SIS. CS can be summarized as an increase in the response of neurons located in the central nervous system to subthreshold stimuli and is the source of chronic pain in many diseases. A decrease in the pressure pain threshold was observed in the painful shoulder of 58 patients with experimental pain response in the shoulder.
In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, while SS was found in 11-24% of patients. The authors emphasized the significant correlation of CS with poor treatment response. There is increasing evidence that CS negatively affects various pain treatment responses, including surgery. Considering the frequency of CS in patients with shoulder pain, it is likely to have a negative impact on treatment response in these patients as well. One of the most common treatments for SIS is subacromial/ intra-articular shoulder injection. Although several factors have been identified in the prediction of shoulder injection outcomes, the effect of pain sensitization on these procedures is not yet known.
This study was designed as a prospective single-center study. Patients aged 18-65 years with rotator cuff lesions lasting more than three months and presenting to our physical medicine and rehabilitation outpatient clinic will be included. Patients who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection. Injection preference will be determined according to the patient primary complaint and lesion and will be administered into the subacromial space or into the shoulder joint. There is no additional interventional procedure due to the study. Patients will be divided into 2 groups with and without central sensitization. A total of 18 patients were planned for each group. The study will be conducted between March 2023 and June 2024.
Within the scope of the study, age, gender, body mass index, marital status, education level and occupation of the participants will be recorded as demographic data. Clinical evaluation includes pain duration, treatments received, pain intensity (numeric pain scale 0-10), disease-related MRI/USG findings and the following evaluations.
All patients will be evaluated before injection, 1 week, 1 and 3 months after injection. Within the scope of evaluation, Central Sensitization Scale, Quick DASH, SF-36 and Hospital Anxiety and Depression questionnaire, pressure pain threshold, goniometric shoulder range of motion measurement, hand grip strength (with Jamar hydraulic hand dynamometer), numeric pain scale (no pain: 0- unbearable pain: 10) and pain intensity will be recorded at each visit.
Data analysis will be performed by using the Statistical Package for the Social Sciences (SPSS, version 23.0, IBM Corp., Armonk, NY, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Patients without central sensitization) | – | Diagnostic Test: Range of Motion of Shoulde Joint, Diagnostic Test: Hand Grip Test, Diagnostic Test: Numeric Rating Scale, Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer, Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Diagnostic Test: Short Form-36, Diagnostic Test: Central Sensitization Scale, Diagnostic Test: Hospital Anxiety and Depression ScalePatients with rotator cuff lesions lasting more than three months and without central sensitization will be included in group 1. (n=18) |
| Group 2 (Patients with central sensitization) | – | Diagnostic Test: Range of Motion of Shoulde Joint, Diagnostic Test: Hand Grip Test, Diagnostic Test: Numeric Rating Scale, Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer, Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Diagnostic Test: Short Form-36, Diagnostic Test: Central Sensitization Scale, Diagnostic Test: Hospital Anxiety and Depression Scalepatients with rotator cuff lesions lasting more than three months and central sensitization will be included in group 2. (n=18) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rotator cuff lesion patients aged between 18-65 years old, who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection visiting our physical medicine and rehabilitation outpatient clinic between March 2023 and June 2024.
Key inclusion criteria (5 listed)
- Clinically and radiographically confirmed rotator cuff pathology
- Being between the ages of 18-65
- Non-response to medical treatment
- Being literate
- To agree to participate in the study
Key exclusion criteria (7 listed)
- History of shoulder trauma and previous shoulder surgery
- Injection in the shoulder area in the last 3 months
- History of active cancer, systemic inflammatory disease and infection
- Pregnancy
- Under 18 and over 65 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Range of Motion of Shoulde JointGoniometric measurements will be made for both upper extremities. Flexion, extension, abduction, adduction, internal and external rotation angles of the shoulder complex will be evaluated in the measurement. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Hand Grip TestThe purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 10 seconds. The test will be repeated for both upper extremities separately. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Numeric Rating ScaleShoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Pain-Pressure Threshold Measurement With an AlgometerThe measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain. The measurement includes bilateral shoulder region and left forearm as control region and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be: 1. Bilateral supraspinatus muscle: 1 cm cranial to the midpoint of the spina scapulae 2. Bilateral infraspinatus muscle: Medial edge of the scapula, intersection of the spina scapula and the inferior scapular angle 3. Bilateral upper trapezius muscle: MidN point of the line joining the acromion and C7 spinous process 4. Left forearm volar face center as control point | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)The arm, shoulder and hand problems rapid questionnaire is a shortened version of a questionnaire designed to detect symptoms and loss of function secondary to musculoskeletal problems of the upper extremity. The questionnaire will be used to assess quality of life related to upper extremity function. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Short Form-36The scale was developed by Ware in 1987 and consists of 36 questions in which 8 sub-parameters related to the health status of the person are questioned. These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. The Turkish validity and reliability of the scale was performed by Pınar et al. It is one of the leading methods used in the evaluation of quality of life in our country as well as all over the world. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Central Sensitization ScaleThe central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
| Hospital Anxiety and Depression ScaleThis scale was developed by Zigmond and Snaith in 1983 to screen anxiety and depression in individuals with physical illness. The scale consists of fourteen questions, seven for anxiety and seven for depression, to be answered on a four-point Likert scale. The Turkish validity and reliability of the scale has been demonstrated and a score above ten for anxiety and seven for depression is considered significant. | Diagnostic test | Group 1 (Patients without central sensitization), Group 2 (Patients with central sensitization) |
Primary outcome
Central Sensitization Scale
Time frame: 12 months
The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain.
7 secondary outcomes
Range of Motion of Shoulde Joint
Time frame: 12 months
Hand Grip Test
Time frame: 12 months
Numeric Rating Scale
Time frame: 12 months
Pain-Pressure Threshold Measurement With an Algometer
Time frame: 12 months
Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
Time frame: 12 months
Short Form-36
Time frame: 12 months
Hospital Anxiety and Depression Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 35382371Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Results publication: PubMed 33123644Walankar PP, Panhale VP, Patil MM. Psychosocial factors, disability and quality of life in chronic shoulder pain patients with central sensitization. Health Psychol Res. 2020 Oct 1;8(2):8874. doi: 10.4081/hpr.2020.8874. eCollection 2020 Oct 5.
- Results publication: PubMed 33399396Previtali D, Bordoni V, Filardo G, Marchettini P, Guerra E, Candrian C. High Rate of Pain Sensitization in Musculoskeletal Shoulder Diseases: A Systematic Review and Meta-analysis. Clin J Pain. 2021 Mar 1;37(3):237-248. doi: 10.1097/AJP.0000000000000914.
- Results publication: PubMed 23619203Coronado RA, Simon CB, Valencia C, George SZ. Experimental pain responses support peripheral and central sensitization in patients with unilateral shoulder pain. Clin J Pain. 2014 Feb;30(2):143-51. doi: 10.1097/AJP.0b013e318287a2a4.
- Results publication: PubMed 25523242Sanchis MN, Lluch E, Nijs J, Struyf F, Kangasperko M. The role of central sensitization in shoulder pain: A systematic literature review. Semin Arthritis Rheum. 2015 Jun;44(6):710-6. doi: 10.1016/j.semarthrit.2014.11.002. Epub 2014 Nov 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre Ata, Ass. Prof. principal investigator
Sultan 2. Abdulhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Lesion and Subacromial Impingement Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404125, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.