Hand OsteoarthritisPhase 2SPLINTOANCT01249391
Splinting to Treat Hand Osteoarthritis
A Phase 2 study testing Splinting in people with Hand Osteoarthritis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often involved causing pain, progressive loss of hand function and deformity. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 90
- Definite diagnosis of IPJ osteoarthritis (American College of Rheumatology criteria for OA)
- A previous radiograph of the hands with changes consistent with OA
- Either, Intervention group: At least 2 'affected' IPJs (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on Xray)
- OR Control group: At least 1 'affected' IPJ (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on X-ray)
- Stable oral therapy for month prior to study entry e.g. non steroidal anti-inflammatory drugs (NSAIDs)
- Capable of providing written informed consent
Who cannot join
- Contraindication to splinting e.g. allergy to materials
- Planned surgery during study period
- Oral, intramuscular or intraarticular steroids within 3 months of study entry
- Intraarticular hyaluronans to any nominated IP joints within 6 months of study entry
- Not resident in UK
- Pregnancy
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- Other inflammatory arthritis
- History of psoriasis
- Participation in other intervention trials
- Patients with any uncontrolled or severe medical problems which in the opinion of the investigator makes them unsuitable for study participation
- Unable to give informed written consent in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)
Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often involved causing pain, progressive loss of hand function and deformity. Deviation, or bending to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for the individual is common. There are no drugs which can slow the disease process so there is reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic splinting (moulded plastic splints that are custom-made) is employed by hand therapists in other settings, but to the investigators knowledge no studies have formally investigated the effect of splinting in IP OA.
By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting in IP OA is likely. In this study, the investigators want to test whether thermoplastic splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft tissue inflammation, and whether as a consequence 3) pain and overall hand function will be improved.
Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially this will be for distal IP (DIP) joints. In the intervention group (30 patients), an 'intervention' joint for splinting will be identified as the most painful deviated DIP joint in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand will not be splinted but will be monitored as 'control' joints. In the control group (15 patients), an affected joint will be monitored but not splinted. Assessment of joint pain, hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to assess whether any changes are persistent. In this way, the efficacy of splinting of IP joints in OA will be assessed.
- Conditions
- Hand Osteoarthritis
- Being tested
- Splinting
- Keywords
- Hand, osteoarthritis, splint, pain, deformity, function
- Medical subject headings
- Osteoarthritis, Pain, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintingDevice
Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention (splinting) | Active comparator | Splinting of nominated joint in this group Receives: Device: Splinting |
| Control | No intervention | Observation and usual treatment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in nominated joint
Assessed via numerical rating scale
Measured: 3 months
Secondary outcomes (1)
Radiological deviation of nominated joint
Degrees of radial or ulnar deviation of joint will be assessed radiographically.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Investigators
- Fiona Watt, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249391
- Sponsor's protocol ID
- JROHH051
- Acronym
- SPLINTOA
- Status last verified
- Jul 2011
- First submitted
- 25 Nov 2010
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Watt FE, Kennedy DL, Carlisle KE, Freidin AJ, Szydlo RM, Honeyfield L, Satchithananda K, Vincent TL. Night-time immobilization of the distal interphalangeal joint reduces pain and extension deformity in hand osteoarthritis. Rheumatology (Oxford). 2014 Jun;53(6):1142-9. doi: 10.1093/rheumatology/ket455. Epub 2014 Feb 8.
PubMed 24509405
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)
- ClinicalTrials.gov ID
- NCT01249391
- Acronym / sponsor ID
- SPLINTOA / JROHH051
- Conditions
- Hand Osteoarthritis
- Keywords
- Hand, osteoarthritis, splint, pain, deformity, function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often involved causing pain, progressive loss of hand function and deformity. Deviation, or bending to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for the individual is common. There are no drugs which can slow the disease process so there is reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic splinting (moulded plastic splints that are custom-made) is employed by hand therapists in other settings, but to the investigators knowledge no studies have formally investigated the effect of splinting in IP OA.
By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting in IP OA is likely. In this study, the investigators want to test whether thermoplastic splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft tissue inflammation, and whether as a consequence 3) pain and overall hand function will be improved.
Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially this will be for distal IP (DIP) joints. In the intervention group (30 patients), an 'intervention' joint for splinting will be identified as the most painful deviated DIP joint in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand will not be splinted but will be monitored as 'control' joints. In the control group (15 patients), an affected joint will be monitored but not splinted. Assessment of joint pain, hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to assess whether any changes are persistent. In this way, the efficacy of splinting of IP joints in OA will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (splinting) | Active comparator | Device: SplintingSplinting of nominated joint in this group |
| Control | No intervention | –Observation and usual treatment only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 - 90
- Definite diagnosis of IPJ osteoarthritis (American College of Rheumatology criteria for OA)
- A previous radiograph of the hands with changes consistent with OA
- Either, Intervention group: At least 2 'affected' IPJs (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on Xray)
- OR Control group: At least 1 'affected' IPJ (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on X-ray)
Key exclusion criteria (11 listed)
- Contraindication to splinting e.g. allergy to materials
- Planned surgery during study period
- Oral, intramuscular or intraarticular steroids within 3 months of study entry
- Intraarticular hyaluronans to any nominated IP joints within 6 months of study entry
- Not resident in UK
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SplintingGutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months | Device | Intervention (splinting) |
Primary outcome
Pain in nominated joint
Time frame: 3 months
Assessed via numerical rating scale
1 secondary outcome
Radiological deviation of nominated joint
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 24509405Watt FE, Kennedy DL, Carlisle KE, Freidin AJ, Szydlo RM, Honeyfield L, Satchithananda K, Vincent TL. Night-time immobilization of the distal interphalangeal joint reduces pain and extension deformity in hand osteoarthritis. Rheumatology (Oxford). 2014 Jun;53(6):1142-9. doi: 10.1093/rheumatology/ket455. Epub 2014 Feb 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Watt principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Splinting in people with Hand Osteoarthritis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in nominated joint (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.