Trial · NCT05299242
The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"
NCT05299242, Phase 2, Phase 3, Completed, University of Oxford; results first posted 2025-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study". Trials, record NCT05299242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05299242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"
- NCT number
- NCT05299242
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Frozen Shoulder
- Interventions
- Adalimumab Injection, Placebo
- First posted
- 2022-03-28
- Last updated
- 2025-01-27
- Results first posted
- 2025-01-27
- Limitations and caveats
This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Eligible With Pain Predominant Frozen Shoulder | 3 Months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Consenting to be Included in the Trial | 3 Months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Time From Randomisation to First Injection | 2 weeks | All participants received their treatment as allocated and in line with the trial protocol. One participant in the adalimumab group received their injection 18 days post- randomisation as they were not available until then. | days | MEAN |
| PRIMARY | Time From First Injection to Second Injection | 6 weeks | All participants received their treatment as allocated and in line with the trial protocol. | days | MEAN |
| PRIMARY | Shoulder Pain and Disability Index (SPADI) Score | Baseline and 3 months | score on a scale | MEAN | |
| SECONDARY | Pain (Shoulder Pain And Disability Index, 5-item Subscale) | Baseline and 3 months | score on a scale | MEAN | |
| SECONDARY | Function (Shoulder Pain And Disability Index, 8-item Subscale) | Baseline and 3 months | score on a scale | MEAN | |
| SECONDARY | Fear Avoidance Belief Questionnaire | Baseline and 3 months | score on a scale | MEAN | |
| SECONDARY | Pain Self Efficacy Questionnaire | Baseline and 3 months | score on a scale | MEAN | |
| SECONDARY | Insomnia Severity Index | Baseline and 3 months | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Eligible With Pain Predominant Frozen Shoulder | All Screened Participants | 39 | Participants | ||
| Number of Participants Consenting to be Included in the Trial | Eligible Participants | 9 | Participants | ||
| Time From Randomisation to First Injection | Adalimumab | 12.3 | Standard Deviation 4.8 | days | |
| Time From Randomisation to First Injection | Placebo | 7.2 | Standard Deviation 4.1 | days | |
| Time From First Injection to Second Injection | Adalimumab | 18.5 | Standard Deviation 3.3 | days | |
| Time From First Injection to Second Injection | Placebo | 20.8 | Standard Deviation 5.9 | days | |
| Shoulder Pain and Disability Index (SPADI) Score | Adalimumab | Baseline | 70.8 | Standard Deviation 16.6 | score on a scale |
| Shoulder Pain and Disability Index (SPADI) Score | Placebo | Baseline | 55.4 | Standard Deviation 21.5 | score on a scale |
| Shoulder Pain and Disability Index (SPADI) Score | Adalimumab | 3 months | 40.1 | Standard Deviation 30.0 | score on a scale |
| Shoulder Pain and Disability Index (SPADI) Score | Placebo | 3 months | 45.8 | Standard Deviation 25.3 | score on a scale |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab | 4 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Adalimumab | 4 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Adalimumab | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, other adverse events | Adalimumab | 0 | 4 |
| Total, other adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | Adalimumab | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 5 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adalimumab vs Placebo: deaths from any cause | Trial comparisons |
| Adalimumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05299242
GET https://conductscience.org/api/trials/v1/NCT05299242/results?page=2