Impact of pain modulation on shoulder pain management.

Does pain modulation influence clinical outcomes in patients with musculoskeletal shoulder pain: A prospective cohort study identifying responders and non-responders

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000114145

Enrollment

119

Registered

2019-01-24

Start date

2019-08-09

Completion date

2022-12-23

Last updated

2024-06-10

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

Conditions

None listed

Brief summary

The primary aims of this study are to: 1) Evaluate pain modulation capacity in people with musculoskeletal shoulder pain; and 2) Investigate the effects of pain modulation on treatment outcomes in people with musculoskeletal shoulder pain. Study design: Prospective longitudinal cohort study with 6-month, 12-month, and 24-month follow up Outcome measures will be collected at baseline and at 6, 12, and 24 months follow up. These include: 1) Demographic, condition history information, physical screening (baseline) 2) Pain modulation tests (predictors, therefore only collected at baseline) and psychosocial questionnaires (baseline) 3) The outcomes to determine treatment effect are the Shoulder Pain & Disability Index and the Global Rating of Change (GROC) score, evaluated at baseline (Shoulder Pain & Disability Index only), and 6, 12, and 24 months follow up. Individuals aged 18-75 years who have a referral for treatment of musculoskeletal shoulder pain will be included in this study. Following baseline assessment, patients will undergo usual care for their shoulder pain, and clinical outcomes (global rating of change; pain and disability) will be collected at 6, 12, and 24 months follow up. The type of treatment received will be elicited from participants at follow up and extracted/confirmed from medical records.

Interventions

Usual care for musculoskeletal shoulder pain within an orthopaedic department in a tertiary care hospital. For example, usual treatment may include conservative (physiotherapy), injection therapy, surgery. Outcome assessment of predictor and confounding variables will occur at baseline, and clinical outcomes assessment will occur at 6, 12, and 24 months follow up.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

- Aged 18 - 75 years - Have a referral to the hospital Orthopaedic Department for shoulder pain - Have the ability to read trial literature (in English) and give consent

Exclusion criteria

- any inflammatory arthritis such as rheumatoid arthritis, - neurological impairment (e.g., stroke, brain injury, nerve injury), - known malignancy, - currently taking neuropathic or opioid pain medication (e.g., gabapentin, pregabalin), - uncontrolled high blood pressure, - history of cardiac disease, - haemophilia, - current pregnancy or breast feeding, - any open wounds or other contraindications (e.g., Raynaud's disease) that will prevent the person from immersing their hand in cold water

Outcome results