Shoulder Impingement Syndrome and Graded Motor Imagery

NCT06092502 | Recruiting

• 1 other identifier: ATADEK-2023/11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Keywords

Shoulder Pain; graded motor imagery

Outcome Measures

Primary Outcomes (4)

• 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.

  Change from baseline range of motion at 6th week

• 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

• 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.

  Change from baseline Global Rating of Change scale at 6th week

• 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 Outcomes (7)

• Range of motion

  Change from baseline range of motion at 6th week

• Pressure Pain Threshold

  Change from baseline Pressure Pain Threshold at 6th week

• Pain Catastrophizing Scale

  Change from baseline score of Pain Catastrophizing Scale at 6th week

• Fear avoidance belief questionnaire (FABQ)

  Change from baseline score of Fear avoidance belief questionnaire at 6th week

• The two-point discrimination test

  Change from baseline two-point discrimination at 6th week

Study Arms (2)

Traditional Physiotherapy Program

ACTIVE COMPARATOR

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

Other: Traditional Physiotherapy Program

Traditional Physiotherapy Program and Graded Motor Imagery Therapy

EXPERIMENTAL

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.

Other: Graded Motor Imagery; Other: Traditional Physiotherapy Program

Interventions

Graded Motor Imagery 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.

Also known as: Traditional Physiotherapy Program

Traditional Physiotherapy Program and Graded Motor Imagery Therapy

Traditional Physiotherapy Program OTHER

This protocol included stretching and strengthening exercises

Traditional Physiotherapy Program; Traditional Physiotherapy Program and Graded Motor Imagery Therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuray Alaca: lead

Study Sites (1)

Nuray ALACA

Istanbul, +90, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Central Study Contacts

Nuray ALACA

CONTACT

+905324251290; nuray.alaca@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Nuray Alaca, Head of Physiotherapy and Rehabilitation Department

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: October 13, 2023
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

TU (1)