Frozen shoulder, e.g. adhesive capsulitis
Conditions
Interventions
Trade Name: Humira
Pharmaceutical Form: Solution for injection
Trade Name: Diprospan
Xylocain 1 %
Pharmaceutical Form: Solution for injection
Sponsors
Pierre Schydlowsky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The diagnosis of adhesive capsulitis. Pain and stiffness of the shoulder predominantly for 3 weeks or more. Restriction of passive motion by more than 30 degrees in 2 or more planes. Age over 18 years. Pain defined as defined as a "Constant score" less or equal to 20 in "Subjective assessment" of "Pain" (maximum score 35). A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)]Use of reliable method of contraception e.g. intra-uterine devices or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential during the entire study and 150 days after cessation of study medication. Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections. Able and willing to give written informed consent and to comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Positive serology for hepatitis B or C indicating active infection. History of positive HIV status, tuberculosis, histoplasmosis or listeriosis. Subjects with latent TB (positive PPD skin test and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB. Persistent or recurrent infections or severe infections requiring hospitalisation or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrolment. History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma or cervical dysplasia. Co morbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), active inflammatory bowel disease, recent stroke (within three months), chronic leg ulcer and any other condition (e.g. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. Female subjects who are pregnant or breastfeeding. History of clinically significant drug or alcohol abuse in the last year. History of or current acute or chronic inflammatory joint disease of origin other than adhesive capsulitis, e.g. radiological evidence of osteoarthritis of the glenohumeral joint on X-ray, ultrasonographic evidence of complete rotatorcuff tear. Previous diagnosis or signs of central nervous system demyelinating diseases (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the improvement of motion in patients with adhesive capsulitis receiving adalimumab in comparison to patients receiving standard therapy. ;Secondary Objective: Secondary to evaluate the sustainability of a potential improvement in motion and the relief of patient experienced pain.;Primary end point(s): Proportion of patients achieving a 50% improvement in passive motion in more than 2 planes at Week 8. Safety will be evaluated by number and severity of AEs reported during the study period. | — |
Countries
Denmark
Outcome results
None listed