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Subacromial Pain Syndrome and Graded Motor Imagery

Primary Purpose

Shoulder Pain, Shoulder Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graded Motor Imagery
Traditional Physiotherapy Program
Sponsored by
Nuray Alaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, graded motor imagery

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 20-50 years of age with complaints of shoulder pain in the anterio-lateral region lasting more than 6 weeks, with a positive Neer impingement test and/or a positive Hawkins-Kennedy test Additionally, patients must have at least one of the symptoms listed. These symptoms are: painful arch on active shoulder elevation, pain with resisted shoulder external rotation in abduction at 90°, and a positive empty can test. Exclusion Criteria: Having had a steroid injection into the shoulder within the last 3 months Previous surgery on the neck, thoracic spine or shoulder Red flags (e.g. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, history of long-term steroid use) History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, frozen shoulder, or cervical or thoracic surgery History of full-thickness rotator cuff tear History of cervical disc herniation in the last 6 weeks History of breast cancer on the involved side Isolated acromioclavicular joint pathology (i.e., pain directly localized over the acromioclavicular joint). Signs of cervical radiculopathy, radiculitis, or referred pain originating from the cervical spine Receiving treatment for shoulder pain in the last 3 months Being currently pregnant (Dunning, 2022) Scoring ≤24 on the Standardized Mini Mental Test was determined.

Sites / Locations

  • Nuray ALACARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Physiotherapy Program

Traditional Physiotherapy Program and Graded Motor Imagery Therapy

Arm Description

This group included strengthening exercises will be applied, including various joint movements and strengthening exercises applied in physiotherapy clinics.

The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.

Outcomes

Primary Outcome Measures

The Numerical Rating Scale (NPRS-11)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
The Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Global Rating of Change scale (Patient Satisfaction)
Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.
Central Sensitization Scale
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.

Secondary Outcome Measures

Range of motion
Shoulder range of motion is the capability of a joint to go through its complete spectrum of movements.
Pressure Pain Threshold
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.The person may score a total of 52 (Pain Catastrophizing Scale). A high score indicates a high level of catastrophic.
Fear avoidance belief questionnaire (FABQ)
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
The two-point discrimination test
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.
Left/right discrimination (Lateralization)
Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.

Full Information

First Posted
October 13, 2023
Last Updated
October 18, 2023
Sponsor
Nuray Alaca
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1. Study Identification

Unique Protocol Identification Number
NCT06092502
Brief Title
Subacromial Pain Syndrome and Graded Motor Imagery
Official Title
The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Subacromial Pain Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
April 13, 2024 (Anticipated)
Study Completion Date
December 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nuray Alaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Graded motor imagery (GMI): used successfully in chronic, complex and painful clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. There is only one study in the literature on subacromial pain syndrome (SAS), which is the most common cause of shoulder pain and causes radiator cuff problems. Stage 2 SAS patients were included in the study and only one phase of GMI treatment was used in addition to the traditional physiotherapy program. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in SAS shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes in central nervous system such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in SAS on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement Syndrome
Keywords
Shoulder Pain, graded motor imagery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Physiotherapy Program
Arm Type
Active Comparator
Arm Description
This group included strengthening exercises will be applied, including various joint movements and strengthening exercises applied in physiotherapy clinics.
Arm Title
Traditional Physiotherapy Program and Graded Motor Imagery Therapy
Arm Type
Experimental
Arm Description
The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery
Other Intervention Name(s)
Traditional Physiotherapy Program
Intervention Description
The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.
Intervention Type
Other
Intervention Name(s)
Traditional Physiotherapy Program
Intervention Description
This protocol included stretching and strengthening exercises
Primary Outcome Measure Information:
Title
The Numerical Rating Scale (NPRS-11)
Description
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Time Frame
Change from baseline range of motion at 6th week
Title
The Shoulder Pain and Disability Index
Description
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Time Frame
Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Title
Global Rating of Change scale (Patient Satisfaction)
Description
Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.
Time Frame
Change from baseline Global Rating of Change scale at 6th week
Title
Central Sensitization Scale
Description
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
Time Frame
Change from baseline score of Central Sensitization Scale scale at 6th week
Secondary Outcome Measure Information:
Title
Range of motion
Description
Shoulder range of motion is the capability of a joint to go through its complete spectrum of movements.
Time Frame
Change from baseline range of motion at 6th week
Title
Pressure Pain Threshold
Description
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Time Frame
Change from baseline Pressure Pain Threshold at 6th week
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.The person may score a total of 52 (Pain Catastrophizing Scale). A high score indicates a high level of catastrophic.
Time Frame
Change from baseline score of Pain Catastrophizing Scale at 6th week
Title
Fear avoidance belief questionnaire (FABQ)
Description
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Time Frame
Change from baseline score of Fear avoidance belief questionnaire at 6th week
Title
The two-point discrimination test
Description
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.
Time Frame
Change from baseline two-point discrimination at 6th week
Title
Left/right discrimination (Lateralization)
Description
Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".
Time Frame
Change from baseline Left/right discrimination at 6th week
Title
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Description
Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.
Time Frame
Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20-50 years of age with complaints of shoulder pain in the anterio-lateral region lasting more than 6 weeks, with a positive Neer impingement test and/or a positive Hawkins-Kennedy test Additionally, patients must have at least one of the symptoms listed. These symptoms are: painful arch on active shoulder elevation, pain with resisted shoulder external rotation in abduction at 90°, and a positive empty can test. Exclusion Criteria: Having had a steroid injection into the shoulder within the last 3 months Previous surgery on the neck, thoracic spine or shoulder Red flags (e.g. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, history of long-term steroid use) History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, frozen shoulder, or cervical or thoracic surgery History of full-thickness rotator cuff tear History of cervical disc herniation in the last 6 weeks History of breast cancer on the involved side Isolated acromioclavicular joint pathology (i.e., pain directly localized over the acromioclavicular joint). Signs of cervical radiculopathy, radiculitis, or referred pain originating from the cervical spine Receiving treatment for shoulder pain in the last 3 months Being currently pregnant (Dunning, 2022) Scoring ≤24 on the Standardized Mini Mental Test was determined.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuray ALACA
Phone
+905324251290
Email
nuray.alaca@acibadem.edu.tr
Facility Information:
Facility Name
Nuray ALACA
City
Istanbul
ZIP/Postal Code
+90
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray ALACA
Phone
+905324251290
Email
nuray.alaca@acibadem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Subacromial Pain Syndrome and Graded Motor Imagery

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