Clinical trial NCT06092489: Chronic Rotator Cuff-related Shoulder Pain and Graded Motor Imagery
Official title: The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Chronic Rotator Cuff-related Shoulder Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Shoulder Pain
Keywords: chronic pain
shoulder pain
graded motor imagery
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 rotator cuff-related 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.


Eligibility criteria: Inclusion Criteria:

Age 18-65 years Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes Pain at rest maximum 2 out of 10 on verbal numerical rating scale Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test

Exclusion Criteria:

Bilateral shoulder pain Corticosteroid injections less than 6 weeks prior to the enrolment Participants who were pregnant, Mini Mental State Examination score \>24 Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test) Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) Primary diagnosis of acromioclavicular pathology, shoulder instability Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication Participants performing overhead sport activities for more than 4hours/week

Primary outcomes:
measure: The Numerical Rating Scale (NPRS-11)
timeFrame: Change from baseline range of motion at 6th week
measure: The Shoulder Pain and Disability Index
timeFrame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
measure: Global Rating of Change scale
timeFrame: Change from baseline Global Rating of Change scale at 6th week
measure: Central Sensitization Scale
timeFrame: Change from baseline score of Central Sensitization Scale scale at 6th week
Secondary outcomes:
measure: Range of motion
timeFrame: Change from baseline range of motion at 6th week]
measure: Pressure Pain Threshold
timeFrame: Change from baseline Pressure Pain Threshold at 6th week
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline score of Pain Catastrophizing Scale at 6th week
measure: Fear avoidance belief questionnaire (FABQ)
timeFrame: Change from baseline score of Fear avoidance belief questionnaire at 6th week
measure: The two-point discrimination test
timeFrame: Change from baseline two-point discrimination at 6th week
measure: Left/right discrimination (Lateralization)
timeFrame: Change from baseline Left/right discrimination at 6th week
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)
timeFrame: Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University
Study officials:
affiliation: Acibadem University
name: Nuray ALACA
role: PRINCIPAL_INVESTIGATOR
References: