Do patients with shoulder complaints need a cervical assessment?

Do patients with localized shoulder pain benefit from cervical-thoracic spine assessment? A mechanical diagnosis and therapy-based prospective cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN42480272

Enrollment

Registered

2025-04-24

Start date

2016-09-26

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized shoulder pain Musculoskeletal Diseases

Interventions

This was a prospective, single-group, test-retest study conducted in five outpatient physiotherapy clinics in Belgium. The study aimed to explore the immediate effects of a Mechanical Diagnosis and Th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary complaint of shoulder pain 2. Pain localized to the shoulder region, specifically the deltoid area 3. Age 18 years or older 4. Ability to read and write Dutch 5. Ability to reproduce shoulder symptoms during clinical mechanical testing 6. Neck Disability Index (NDI) score =15/100. This threshold was used to exclude patients with significant neck-related disability.

Exclusion criteria

Exclusion criteria: 1. Neck Disability Index (NDI) score >15/100 2. To exclude individuals with significant cervical spine involvement 3. Known or suspected specific shoulder or neck pathology, including: 3.1. Cervical spinal stenosis or nerve root compression 3.2. Shoulder or cervical fractures 3.3. Adhesive capsulitis (frozen shoulder) 3.4 History of cervical or shoulder surgery within the previous 6 months 3.5. Recent traumatic injury affecting the shoulder or cervical spine 3.6. Signs or symptoms of cervical radiculopathy 4. Serious comorbidities that could interfere with participation, such as: 4.1. Active cancer or metastases 4.2. AIDS or immunodeficiency 4.3. History of cerebrovascular accident (stroke) 4.4. Psychiatric or cognitive disorders that could impair understanding or compliance 5. Inability to demonstrate reproducible shoulder symptoms during baseline mechanical examination 6. Inability to provide informed consent or complete questionnaires in Dutch

Design outcomes

Primary

Measure	Time frame
1. Change in clinical shoulder test results measured using five standardized physical tests: 1.1. Hand-to-Scapula (HTS) test 1.2. Neer test 1.3. Hawkins-Kennedy test 1.4. Jobe (Empty Can) test 1.5. Active shoulder abduction test Each test is assessed for pain provocation and functional limitation at baseline (prior to intervention) and immediately post-intervention, both on Day One of the clinical assessment. 2. Pain intensity is measured using the Numeric Pain Rating Scale (NPRS; 0–10) during each shoulder test at baseline and immediately after MDT intervention, both on Day One 3. Shoulder range of motion is measured using a goniometer (specifically for active abduction) at baseline and immediately after intervention, both on Day One 4. Hand-to-Scapula (HTS) functional level is recorded using a 5-point ordinal scale at baseline and immediately post-intervention, both on Day One A test was considered improved if: 1. Pain provocation decreased by =2 points on a Numeric Pain Rating Scale (NPRS; 0–10) during the test, or 2. Functional improvement was recorded: 2.1. =20% improvement in active range of motion (measured with a goniometer) 2.2. =1-point improvement on the HTS 5-point functional rating scale	—

Measure

Time frame

1. Change in clinical shoulder test results measured using five standardized physical tests: 1.1. Hand-to-Scapula (HTS) test 1.2. Neer test 1.3. Hawkins-Kennedy test 1.4. Jobe (Empty Can) test 1.5. Active shoulder abduction test Each test is assessed for pain provocation and functional limitation at baseline (prior to intervention) and immediately post-intervention, both on Day One of the clinical assessment. 2. Pain intensity is measured using the Numeric Pain Rating Scale (NPRS; 0–10) during each shoulder test at baseline and immediately after MDT intervention, both on Day One 3. Shoulder range of motion is measured using a goniometer (specifically for active abduction) at baseline and immediately after intervention, both on Day One 4. Hand-to-Scapula (HTS) functional level is recorded using a 5-point ordinal scale at baseline and immediately post-intervention, both on Day One A test was considered improved if: 1. Pain provocation decreased by =2 points on a Numeric Pain Rating Scale (NPRS; 0–10) during the test, or 2. Functional improvement was recorded: 2.1. =20% improvement in active range of motion (measured with a goniometer) 2.2. =1-point improvement on the HTS 5-point functional rating scale

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Secondary

Measure	Time frame
1. Global perceived effect (GPE) on pain and function is self-reported by participants using a percentage improvement scale immediately post-intervention on Day One. A change of =20% is considered clinically meaningful. 2. MDT classification outcome is recorded by the treating therapist during the MDT assessment session on Day One. Based on the principles of Mechanical Diagnosis and Therapy (MDT), patients are classified as: 2.1. Cervical Derangement (CD) 2.2. Cervical Non-Derangement (CND) Classification is guided by the presence or absence of a Directional Preference (DP) — a repeated movement direction that leads to symptom reduction, centralization, or improved function. Questionnaires used in the study: These were all completed at baseline (Day One) by the participant before the clinical shoulder and MDT assessments: 1. Neck-related disability (to screen out patients with significant cervical impairment) assessed using the Neck Disability Index (NDI) 2. Shoulder pain and functional impairment evaluated using the Shoulder Pain and Disability Index (SPADI) at baseline. 3. Shoulder function measured using the Simple Shoulder Test (SST) at baseline 4. General health-related quality of life measured using the RAND-36 Health Survey at baseline	—

Measure

Time frame

1. Global perceived effect (GPE) on pain and function is self-reported by participants using a percentage improvement scale immediately post-intervention on Day One. A change of =20% is considered clinically meaningful. 2. MDT classification outcome is recorded by the treating therapist during the MDT assessment session on Day One. Based on the principles of Mechanical Diagnosis and Therapy (MDT), patients are classified as: 2.1. Cervical Derangement (CD) 2.2. Cervical Non-Derangement (CND) Classification is guided by the presence or absence of a Directional Preference (DP) — a repeated movement direction that leads to symptom reduction, centralization, or improved function. Questionnaires used in the study: These were all completed at baseline (Day One) by the participant before the clinical shoulder and MDT assessments: 1. Neck-related disability (to screen out patients with significant cervical impairment) assessed using the Neck Disability Index (NDI) 2. Shoulder pain and functional impairment evaluated using the Shoulder Pain and Disability Index (SPADI) at baseline. 3. Shoulder function measured using the Simple Shoulder Test (SST) at baseline 4. General health-related quality of life measured using the RAND-36 Health Survey at baseline

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Countries

Belgium

Contacts

Public ContactDavid Vandeput

david.vandeput@kuleuven.be+32 (0)472651625

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026