The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-21

Study Completion Date

2023-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Frozen shoulder is a common condition affecting approximately 9% of people aged 25-64 years. During the early phase the pain is usually unbearable and the later restriction in movement is severely limiting. It occurs when the flexible tissue (capsule) that surrounds the shoulder joint becomes inflamed, thickened and tight. The pain can be very severe and lasts 3-9 months, followed by a 4-12 month period of increasing stiffness, after which the condition usually improves. Frozen shoulder often affects a person's ability to sleep, carry out everyday activities, and work. Current treatments include rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. If stiffness persists, surgery is sometimes recommended. However, there is no evidence that any of these treatments lead to significant benefit in the long term, with many being ineffective. The aim of this study is to find out if it is possible to run a larger trial to test whether an injection of adalimumab can reduce pain and prevent the disease from getting worse, if given during the early painful phase of frozen shoulder. The investigators need to conduct this smaller study first to be sure it's possible to identify and treat people with early stage frozen shoulder, before they conduct a much larger trial to find out if this treatment works.

In this study the investigators will include 84 adults from 5 sites with painful early stage frozen shoulder who have not yet received treatment. People will be randomised to receive either an injection of the drug adalimumab or a dummy injection of saline (placebo) directly into the shoulder joint, both guided by ultrasound. All participants will also receive standardized advice on how to manage their shoulder pain. The investigators will assess participants before treatment and three months later. Adalimumab has been used very successfully to treat other inflammatory diseases such as rheumatoid arthritis. This study has been funded by the NIHR RfPB programme and 180 Life Sciences.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome

NCT01554670

Rotator Cuff Shoulder Syndrome and Allied Disorders

COMPLETED PHASE4

The Study of Different Treatment Programs for Patients With Frozen Shoulder

NCT01249040

Frozen Shoulder

UNKNOWN NA

A Trial Comparing Glenohumeral Joint Steroid Injection Versus Suprascapular Nerve Block in Patients With Frozen Shoulder

NCT04965376

Frozen Shoulder

UNKNOWN PHASE4

Pain Managment in Chronic Shoulder Pain

NCT06106490

Chronic Pain Management

RECRUITING NA

Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

NCT03232749

Osteoarthritis of the Glenohumeral Joint

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frozen Shoulder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Participants will be randomised to either receive Adalimumab or Placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The participant will be blinded along with the assessor and other site staff. The injector and pharmacy will not be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Participants will receive 2 injections of adalimumab. First injection: 160mg in 3.2ml Second injection approximately 2-3 weeks later 80mg in 1.6ml

Group Type ACTIVE_COMPARATOR

Adalimumab Injection

Intervention Type DRUG

40mg in 0.8ml preparation in vials from Fresenius Kabi Ltd

Arm B

Participants will receive 2 injections of placebo First injection: 3.2ml Second injection approximately 2-3 weeks later 1.6ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline \[0.9% NaCl\]

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adalimumab Injection

40mg in 0.8ml preparation in vials from Fresenius Kabi Ltd

Intervention Type DRUG

Placebo

Saline \[0.9% NaCl\]

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Men and women aged 18 years and above.
2. With a new episode of shoulder pain attributable to pain-predominant stage of frozen shoulder (i.e. within approximately 3 months of onset of symptoms) diagnosed using criteria set out in the BESS guidelines (33) (Appendix 1);
3. Who are not being considered for surgery;
4. Able to understand spoken and written English;
5. Willing and able to give informed consent for trial participation and comply with all study requirements and time line;
6. Willing to allow his or her General Practitioner be notified of participation in the trial.
7. If female and of child-bearing potential OR if male and their partner is of child-bearing potential - willing to use effective contraception throughout the treatment period and for 5 months after the last injection.-

Exclusion Criteria

1. Those with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g. recent breast cancer surgery or radiotherapy);
2. Those with a neurological disease affecting the shoulder;
3. Those with bilateral concurrent frozen shoulder;
4. Those with other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out in the BESS guidelines (33);
5. Those who have received corticosteroid injection for shoulder pain in the last 12 weeks to either shoulder;
6. Those currently taking any anti-TNF drug;
7. Those being treated with coumarin anticoagulants, such as warfarin;
8. Those who have participated in another research study involving an investigational medicinal product in the past 12 weeks;
9. Those with significant renal or hepatic impairment;
10. Those with contra-indications to anti-TNF injection:

10.1 Known allergy to any anti-TNF agent or any of the excipients; 10.2 Known Active tuberculosis (TB) or history of TB. 10.3 Known Active infection (chronic or localised) or known history of recurring infections or condition which may predispose patients to infection, including the use of concomitant immunosuppressive medications; 10.4 Known Moderate to severe heart failure (NYHA class III/IV); 10.5 Those known to have HIV, Hepatitis B or C; 10.6 Those at risk of Hepatitis B infection; 10.7 Those diagnosed with Multiple Sclerosis (MS) or other central or peripheral nervous system demyelinating disorders; 10.8 Those who have ever been diagnosed with cancer, except basal cell carcinoma (BCC); 10.9 Those requiring live vaccination prior to within 12 weeks after of the last trial injection or within the 4 weeks prior to randomisation; 10.10 Those taking biologic DMARDS; 10.11 Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No