Trial · NCT05299242
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Eligible With Pain Predominant Frozen Shoulder | 3 Months | Ability to screen and identify potential participants with pain-predominant early stage frozen shoulder (i.e. within approximately 3 months of onset of symptoms). |
| Primary | Number of Participants Consenting to be Included in the Trial | 3 Months | Willingness of eligible participants to consent and be randomised to intervention. |
| Primary | Time From Randomisation to First Injection | 2 weeks | Practicalities of delivering the intervention, including time to first injection (within 2 weeks of randomisation). |
| Primary | Time From First Injection to Second Injection | 6 weeks | Practicalities of delivering the intervention, including time between first injection and second injection (within 4-6 weeks of randomisation). |
| Primary | Shoulder Pain and Disability Index (SPADI) Score | Baseline and 3 months | Score ranges from 0 to 100, lower scores indicate better outcome. |
| Secondary | Pain (Shoulder Pain And Disability Index, 5-item Subscale) | Baseline and 3 months | Score ranges from 0 to 100, lower scores indicate better outcome. |
| Secondary | Function (Shoulder Pain And Disability Index, 8-item Subscale) | Baseline and 3 months | Score ranges from 0 to 100, lower scores indicate better outcome. |
| Secondary | Fear Avoidance Belief Questionnaire | Baseline and 3 months | Score ranges from 0 to 24, higher scores indicate better outcomes. |
| Secondary | Pain Self Efficacy Questionnaire | Baseline and 3 months | Score ranges from 0 to 12, higher scores indicate better outcomes. |
| Secondary | Insomnia Severity Index | Baseline and 3 months | Sleep disturbance measured using the Insomnia Severity Index, score ranges from 0 to 28, higher scores indicate worse outcomes. |
| Secondary | Return to Desired Activities (RDA) | Baseline and 3 months | Return to desired activities measured using an adapted version of the Disabilities of the Arm, Shoulder and Hand (QUICKDASH) questionnaire. Score ranges from 3 to 15, lower scores indicate better outcomes. |
| Secondary | Global Impression of Change | 3 months | This was measured using the Likert scale. Score ranges from -5 (very much worse) to +5 (completely recovered) with a value of 0 suggesting no change. Higher scores indicate better outcomes. |
| Secondary | Health Resource Use | 3 months | Consultation with primary and secondary care, additional physiotherapy, injection use, or alternative therapies for index shoulder |
| Secondary | Adverse Events Graded 3 or Above | Consent to 3 months follow-up | Any adverse event (graded 3 or above) that has resulted from the trial. The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was used to guide recording adverse events including grading of the event. Grade 3: Severe symptoms or medically significant but not life-threatening but may be disabling or limit self care in Activities of Daily Living. Grade 4: Life threatening consequences; urgent or emergent intervention needed. Grade 5: Death related to or due to adverse event. |
| Secondary | Shoulder Range of Movement | Baseline and 3 months | Clinician assessed (goniometry measured) active shoulder flexion, extension, abduction, internal and external rotation. Range of flexion and abduction: 0-180 degrees. Range of extension, internal rotation and external rotation: 0-90 degrees. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT05299242/registered