Osteoarthritis Thumb
Conditions
Keywords
thumb, pain, inflammation, steroids, RCT, Occupational Therapy, Carpometacarpal-1, HappyHands, CMC-1, Picasso, intraarticular corticosteroid injections, IACS injections, thumb base pain, triamcinolone acetonide, Kenacort-T, osteoarthritis, OA
Brief summary
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
Detailed description
The primary aim of the PICASSO trial is to examine the efficacy and safety of intraarticular corticosteroid injections and a multimodal occupational therapy intervention in patients with CMC-1 OA (Phase 1). By comparing available non-pharmacological and pharmacological treatments head-to-head, our results will be of interest to the range of health professionals who are involved in the management of CMC-1 OA patients. By including patients who are likely to benefit from the intervention (painful and inflammatory CMC-1 OA), appropriate dosage of drug and ultrasound-guided injections, our trial is more guarded against possible false negative results than previous studies. We will also explore predictors for treatment effects. Due to the heterogeneous presentation of OA, it is unlikely that one treatment will fit all, and treatment should be tailored to the patients´ clinical presentation. Second, we will explore the long-term safety of IACS, and whether the occupational therapy intervention can prevent or halt CMC-1 subluxation (Phase 2).
Interventions
DRUGInjection of triamcinolone acetonide into the CMC-1 joint
intraarticular injection with triamcinolone acetonide
BEHAVIORALMultimodal Occupational therapy for CMC-1 joint OA
Patient education, instructions about hand exercises, orthosis and training
DRUGPlacebo
Intraarticular injection with saline
Sponsors
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
Helse Stavanger HF
Haugesund Rheumatism Hospital
St. Olavs Hospital
Nordlandssykehuset HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participants and the occupational therapist who examine the patients are blinded for the content of the intraarticular injections. The rheumatologist who perform the intraarticular injection will not be blinded for the content.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\- Adult (40-85 years of age) men and women In target CMC-1 joint: * OA confirmed by radiographs or ultrasound examination, and * Inflammation by ultrasound (grey scale synovitis grade 1-3), and * Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at rest or during activities at both pre-screening and screening. * Patient is assessed as eligible for the proposed use of Kenacort-T
Exclusion criteria
* Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks * Intraarticular injections in the target CMC-1 joint in the last 12 weeks * More than 3 previous IACS in the target CMC-1 joint * Use of oral, intramuscular or intravenous steroids in the last 12 weeks * Previous surgery of the target CMC-1 joint * Planned hand surgery in the coming 24 weeks * Do not want to quit using oral or topical NSAIDs on the hands (such as ibuprofen, diclofenac, etoricoxib, naproxen) in the next 12 weeks * Systemic inflammatory joint diseases (such as rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis/trigger finger) * Diagnosis of fibromyalgia * Diagnosis of psoriasis * Infection, skin disease or wounds at joint injection site * Serious comorbidities, cognitive dysfunction, substance/alcohol abuse or any other medical condition that makes adherence to the study protocol difficult * Severe or uncontrolled infections * Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid) * Included in another clinical study * Use of digitalis glycosides * Patients vaccinated or immunized with live virus vaccines in the last 2 weeks * Not being able to talk or understand Norwegian * Known pregnancy or planned pregnancy in the next 6 months * Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during activities in thumb base joint | 4 and 12 weeks | Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during activities in thumb base joint | All visits | Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable. |
| Pain at rest in thumb base joint | Week 00, 04, 12, 24, 104 | Change in thumb base joint pain at rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable. |
| Pain during activities in finger joints | Week 00, 04, 12, 24, 104 | Change in finger joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable. |
| Pain at rest in finger joints | Week 00, 04, 12, 24, 104 | Change in finger joint pain in rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable. |
| AUSCAN (Australian/Canadian hand index) | Week 00, 04,12, 24 and 104 | Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales. Sum scores for pain (range: 0-20), stiffness (range: 0-4) and function (range: 0-36) can be calculated with higher scores representing worse health. |
| OMERACT-OARSI criteria responders | Week 00, 04, 12, 24, 104 | Number of OMERACT-OARSI criteria responders |
| MAP-Hand | Week 00, 04,12, 24 and 104 | Change in measure of activity performance of the hand |
| Patient-reported overall disease activity | Week 00, 04, 12, 24, 104 | Change in patient-reported overall disease activity in hands last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no disease activity and 10 being the worst disease activity imaginable. |
| Assessor-reported overall disease activity | Week 00, 04, 12, 24, 104 | Change in assessor-reported overall disease activity in hands on a 0-10 Numeric Rating Scale (NRS). 0 being no disease activity and 10 being the worst disease activity imaginable. |
| Pain in finger joints (hand figure) | Week 00, 04, 12, 24, 104 | Change in pain in finger joints last 24 hours (hand figure) |
| Grip strength | Week 00, 04, 12, 24, 104 | Change in grip strength |
| Use of analgesics | Week 00, 04, 12, 24, and 104 | Change in use of analgesics |
| Use of NSAIDs | Week 00, 04, 12, 24, and 104 | Change in use of non-steroidal anti-inflammatory drugs (NSAIDs) |
| Arthritis self-efficacy scale | Week 00, 04, 12, 24, 104 | Change in arthritis self-efficacy scale. The response categories are 10-100 with 10 points increment between each response category. A sum score is created based on the average of the five questions. Higher scores represent better self-efficacy. |
| Patient satisfaction | Week 04, 12 | Number of responders regarding self-reported perceived effect of treatment (yes/no). Patient satisfaction will be assessed with a question about whether the participants believe that they have had effect of the received treatment. |
| EuroQol 5 dimensions 5-levels (EQ-5D-5L) | Week 00, 04, 12, 24,104 | Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. On the EQ-VAS the participant is instructed to self-rate their health on a 0-100 scale, where 0=worst health and 100=best health. |
| Tender hand joints | Week 00, 04, 12, 24, 104 | Change in number of tender hand joints |
| Swollen hand joints | Week 00, 04, 12, 24, 104 | Change in number of swollen hand joints |
| Ultrasound synovitis in the CMC-1 joint | Week 00, 04,12, 24, 104. Will also be assessed in relation to additional injections in Phase 2. | Change in ultrasound synovitis in the CMC-1 joint |
| Synovitis in the CMC-1 joint | Week 00, 04 | Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI |
| Bone marrow lesions in the CMC-1 joint | Week 00, 04 | Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI |
| Structural progression | Week 00, 104 | Change in structural progression by Kellgren-Lawrence |
| Osteophytes | Week 00, 104 | Change in osteophytes by OARSI atlas |
| Joint space narrowing | Week 00, 104 | Change in joint space narrowing by OARSI atlas |
| Subluxation of the CMC-1 joint | Week 00, 104 | Change in subluxation of the CMC-1 joint |
| Adverse events | Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2. | Number of adverse events |
| Serious adverse events | Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2. | Number of serious adverse events |
| Withdrawals because of adverse events | Week 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2. | Number of withdrawals because of adverse events |
| Use of healthcare services | Week 00, 12, 24, 104 | Questions about use of healthcare services |
Countries
Norway
Contacts
CONTACTIda Kristin Haugen, MD, PhD
CONTACTMarthe Gløersen, MD
STUDY_DIRECTORIda Kristin Haugen, MD, PhD
Diakonhjemmet Hospital
PRINCIPAL_INVESTIGATORMarte Ingeborg Sæther
Martina Hansens Hospital
PRINCIPAL_INVESTIGATORElisabet Esperø
Haugesund Rheumatism Hospital
PRINCIPAL_INVESTIGATORKatrine Brække Norheim
Helse Stavanger HF
PRINCIPAL_INVESTIGATORMari Hoff
St. Olavs Hospital
PRINCIPAL_INVESTIGATORGöran Karlsson
Nordland Hospital
Outcome results
None listed