Aim of this study is to investigate the short and long term effectiveness of a multidisciplinary self-management program (by an occupational therapist and a specialized nurse) on limitations in activities and pain.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in percentage patients that is clinical responder in pain
(Visual Analogue Scale (VAS)), physical functioning (The Australian Canadian
(AUSCAN) questionnaire for Hand OA) and self perceived effect (patient global
assessment (PGA)) according to the OMERACT OARSI responders criteria.
Secondary outcome
Handfunction
- Dutch AIMS2 subscale hand and fingers
Quality of Life / impact of hand OA
- The Canadian Occupational Performance Measure (COPM) ). A *patient oriented*
measurement designed to identify the
perceived main problems of patients
- Impact of handproblems: Subscale of the Dutch-AIMS2:
- SF-36 questionnaire
Pain
- Pain Coping Inventory (PCI);
- Tender joint count (hand joints).
Overig
- Self-efficacy: Arthritis self-efficacy scale and Dutch General Self-efficacy
scale;
- Gripstrength in Nm: pinch and gripstrength.
Background summary
In the recently published EULAR guidelines for management of hand OA it is
strongly recommended to treat al patients with hand OA with a combination of
pharmacological and non-pharmacological interventions. However, research on the
effectiveness of non pharmacological interventions is very limited. In the
EULAR recommendations is recommended to treat patients with a non-
pharmacological intervention existing of education and hand exercises. However,
this recommendation is based on one low quality study with limited patients.
Study objective
Aim of this study is to investigate the short and long term effectiveness of a
multidisciplinary self-management program (by an occupational therapist and a
specialized nurse) on limitations in activities and pain.
Study design
A single blind randomized controlled trial. The experimental intervention is a
multidisciplinary treatment program for hand OA. The control group starts with
a three months waiting time followed by the same multidisciplinary treatment
program. After the intervention patients will be randomized into a group who
receive an additional booster session or not. The assessor is blinded towards
the results of the randomization procedure.
Intervention
Multidisciplinary self-management treatment (occupational therapist and a
specialized nurse) existing of four group sessions, 2.5 hours each. The
content of the treatment program includes information about OA and treatment
options; principles of joint protection; education about active coping
strategies; range of motion and strengthening exercises; and, if considered
necessary, advice about orthoses in patients with OA of CMC I. Depending on the
results of the randomization procedure patients follow an additional booster
session. In the additional booster session the successes and failures of
patients to implement strategies to cope with pain and limitations in their
daily life will be discussed. Furthermore, the major topics addressed in the
first four sessions will be repeated.
Study burden and risks
The burden for patients in this study will be low. The outcome measures are
widely accepted questionnaires. The blood test (taken at study entry) will be
obtained by a trained employee. One standard X-ray (both hands) will be
obtained before the start of the study.
Postbus 9011
6500 GM Nijmegen
NL
Postbus 9011
6500 GM Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Hand OA according to the ACR classification tree for symptomatic Hand OA: Hand pain, aching, or stiffness during most days and 3 or 4 of the following features:
Hard tissue enlargement of 2 or more of 10 selected joints*
Hard tissue enlargement of 2 or more DIP joints
Fewer than 3 swollen MCP joints
Deformity of at least 1 of 10 selected joints*
* The 10 selected joints are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands.
- Score at AUSCAN > 1 ;
- Pain in hand(s) is main problem;
- Refered by a rheuamtologist (secundary care);
Exclusion criteria
- Other rheumatic diseases like rheumatoid artritis, fibromyalgia, gout, psoriatic arthritis;
- Compression syndrome of n. medianus;
- Psychiatric problems;
- Prothesis of one or more joints of the hand/wrist;
- Red flags
- Persons who are not willing to participate in a group intervention
- insufficient ability to read and communicate in Dutch to fullfill questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20186.091.07 |