Chronic Rotator Cuff-related Shoulder Pain and Graded Motor Imagery

NCT ID: NCT06092489

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-07-10

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.

Conditions

Chronic Pain; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traditional Physiotherapy Program

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 . These workouts and workouts are also arranged regularly. After exercise, ice will be applied to the shoulder for 15 minutes.

Group Type: ACTIVE_COMPARATOR

traditional physiotherapy method

Intervention Type: OTHER

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.

Traditional Physiotherapy Program and Graded Motor Imagery Therapy

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.

Group Type: EXPERIMENTAL

graded motor imagery

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuray Alaca

OTHER

Sponsor Role: lead

Responsible Party

Nuray Alaca

Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nuray ALACA

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

Acıbadem University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sirlan S, Alaca N, Yarar HA, Basci O. Graded motor imagery as an adjunct to comprehensive physiotherapy in chronic rotator cuff-related pain: a single blind randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 3;26(1):588. doi: 10.1186/s12891-025-08783-w.

Reference Type: DERIVED

PMID: 40611093 (View on PubMed)

Other Identifiers

2023/21-13

Identifier Type: -

Identifier Source: org_study_id