Chronic Shoulder Pain and Graded Motor Imagery

Chronic Pain Clinical Trial

Official title:

The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Chronic Shoulder Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092489
• Other study ID #: 2023/21-13
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: December 13, 2024

Study information

• Verified date: February 2024
• Source: Acibadem University
• Contact: Nuray ALACA
• Phone: +905324251290
• Email: nuray.alaca[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Graded motor imagery (GMI) 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. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in chronic shoulder pain 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 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 chronic shoulder pain 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants aged 20-65 with unilateral shoulder pain lasting more than three months

Exclusion Criteria:

• • Complete rotator cuff tear,

• Shoulder instability,

• Shoulder dislocation,

• Hemiplegic shoulder pain,

• Any upper extremity surgery,

• Any systemic condition affecting the neck, back and upper extremity,

• Bilateral shoulder pain,

• Any accompanying cervical pain or injury

Related Conditions & MeSH terms

• Chronic Pain
• Shoulder Pain

Intervention

Other:
• graded motor imagery
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.
• traditional physiotherapy method
This protocol included stretching and strengthening exercises. Self-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Nuray Alaca

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Numerical Rating Scale (NPRS-11)	he 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.	Change from baseline range of motion at 6th week
Primary	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.	Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Primary	Global Rating of Change scale	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.	Change from baseline Global Rating of Change scale at 6th week
Primary	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.	Change from baseline score of Central Sensitization Scale scale at 6th week
Secondary	Range of motion	Shoulder range of motion is the capability of a joint to go through its complete spectrum of movements.	Change from baseline range of motion at 6th week]
Secondary	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).	Change from baseline Pressure Pain Threshold at 6th week
Secondary	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.	Change from baseline score of Pain Catastrophizing Scale at 6th week
Secondary	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)	Change from baseline score of Fear avoidance belief questionnaire at 6th week
Secondary	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	Change from baseline two-point discrimination at 6th week
Secondary	Left/right discrimination (Lateralization)	Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".	Change from baseline Left/right discrimination at 6th week
Secondary	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.	Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week