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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
40mg in 0.8ml preparation in vials from Fresenius Kabi Ltd
Saline \[0.9% NaCl\]
Good Hope Hospital
Sutton Coldfield, Birmingham, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, Hastings, United Kingdom
Grantham & District Hospital, United Lincolnshire Hospitals
Grantham, Lincolnshire, United Kingdom
Sandwell General Hospital
West Bromwich, West Midlands, United Kingdom
Number of Participants Eligible With Pain Predominant Frozen Shoulder
Ability to screen and identify potential participants with pain-predominant early stage frozen shoulder (i.e. within approximately 3 months of onset of symptoms).
Time frame: 3 Months
Number of Participants Consenting to be Included in the Trial
Willingness of eligible participants to consent and be randomised to intervention.
Time frame: 3 Months
Time From Randomisation to First Injection
Practicalities of delivering the intervention, including time to first injection (within 2 weeks of randomisation).
Time frame: 2 weeks
Time From First Injection to Second Injection
Practicalities of delivering the intervention, including time between first injection and second injection (within 4-6 weeks of randomisation).
Time frame: 6 weeks
Shoulder Pain and Disability Index (SPADI) Score
Score ranges from 0 to 100, lower scores indicate better outcome.
Time frame: Baseline and 3 months
Pain (Shoulder Pain And Disability Index, 5-item Subscale)
Score ranges from 0 to 100, lower scores indicate better outcome.
Time frame: Baseline and 3 months
Function (Shoulder Pain And Disability Index, 8-item Subscale)
Score ranges from 0 to 100, lower scores indicate better outcome.
Time frame: Baseline and 3 months
Fear Avoidance Belief Questionnaire
Score ranges from 0 to 24, higher scores indicate better outcomes.
Time frame: Baseline and 3 months
Pain Self Efficacy Questionnaire
Score ranges from 0 to 12, higher scores indicate better outcomes.
Time frame: Baseline and 3 months
Insomnia Severity Index
Sleep disturbance measured using the Insomnia Severity Index, score ranges from 0 to 28, higher scores indicate worse outcomes.
Time frame: Baseline and 3 months
Return to Desired Activities (RDA)
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.
Time frame: Baseline and 3 months
Global Impression of Change
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.
Time frame: 3 months
Health Resource Use
Consultation with primary and secondary care, additional physiotherapy, injection use, or alternative therapies for index shoulder
Time frame: 3 months
Adverse Events Graded 3 or Above
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.
Time frame: Consent to 3 months follow-up
Shoulder Range of Movement
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.
Time frame: Baseline and 3 months
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