Inflammatory ArthritisC-GLOVESNCT01874067
C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
An observational study of Inflammatory Arthritis and Rheumatoid Arthritis, run by University of Salford at 5 sites in United Kingdom.
Trial summary
This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand pain, swelling and stiffness. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inflammatory Arthritis, Rheumatoid Arthritis, Hand Osteoarthritis
- What is being tested?
- Arthritis glove
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Oct 2013to Mar 2015
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatology Occupational Therapy and Hand Therapy out-patient departments
Who may be able to join
- experiencing hand pain and swelling
Who cannot join
- unable to give informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Occupational Therapy, Leighton Hospital
Crewe, Cheshire, CW1 4QJ
Occupational Therapy, Victoria Infirmary
Northwich, Cheshire, CW8 1AW
Occupational Therapy, Southport District General Hospital
Southport, Merseyside, PR8 6PN
Ocupational Therapy, St Helens Hospital
St Helens, Knowsley, WA9 3DA
Occupational Therapy Department, Stepping Hill Hospital
Stockport, Greater Manchester, SK2 7JE
About this study
Official title: C-GLOVES: an Evaluation of the Effectiveness of Compression Gloves in Arthritis: a Feasibility Study
This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand pain, swelling and stiffness. People find they help but there is little research testing this. Of the five small studies published: two found little or no benefit; one found similar effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if gloves work helps therapists and patients judge if they will help.
This is a feasibility study to help us plan a future trial testing if arthritis gloves work for people with arthritis. We aim to find out: the rate we can recruit people to the study; if OTs can assess people's hands and provide gloves as agreed; how many people do we need to take part in a trial; what do people think (if any) is the gloves' most important effect and how long should we test them for? We will analyse the data to see what effect the gloves have.
The study will last 12 months. People will get arthritis gloves as part of their usual care. The OTs have agreed a standard way of assessing and providing the gloves to ensure best practice across departments. The assessments include: difficulties using hands, pain and stiffness levels, and measuring hand and finger joint size and movement. People can take part if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter length gloves; can attend the usual 4 week review appointment for re-assessment; will allow us to use their anonymized hand assessments. We will also interview some people about their views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.
Read the detailed description
Design:
An observational study of usual care providing arthritis gloves with pre- and 4 weeks post-treatment assessment. Participants are screened and recruited (if eligible and consenting) as they attend for glove provision as part of routine care. (Participants are not randomly assigned).
Intervention:
Three-quarter length finger Isotoner glove(s) for one or both hands, as required. The participating OTs determine if patients meet their agreed criteria for gloves as part of usual care. Usually at the same appointment the OT then assesses for and provides these using the assessment and treatment protocols agreed by North West England College of Occupational Therapists Specialist Section - Rheumatology (NWCOTSS-R) members as part of their usual care. Four weeks later, patients attend a review appointment (as part of their usual care) for re-assessment of their hand(s), and to identify any effects the gloves have had and if any problems arose meaning glove wear should be stopped or the wear regimen altered. Normally the patient attends for two appointments only.
Occupational therapist (OT) training
The members of the NWCOTSS-R group agreed the glove provision criteria, hand assessment and treatment protocols and glove instruction sheet in order to improve standards of usual care in glove provision across Rheumatology OT departments. Prior to recruitment commencing, the participating OTs attended a training meeting to ensure they:
- performed the hand assessments (i.e. swelling, finger flexion and Grip Ability Test) reliably.
- Know how to correctly size and fit the gloves following training by an experienced Rheumatology OT
- understand the study procedures, know how to take study specific consent and complete study site documentation.
A standardised assessment kit and manual was provided to the OTs by the University research centre.
Study criteria:
Inclusion:
- Meet the criteria agreed by NWCOTSS-R members for receiving compression gloves as part of usual OT care.
- Adults with either:
- early inflammatory, probable or definite RA, diagnosed by a Rheumatology Consultant ii. hand OA, diagnosed by a GP, Consultant or Advanced Practitioner.
- Willing and able to wear three-quarter length Isotoner glove(s), following the glove fitting process.
- Willing to attend for the glove review appointment (part of usual care) approximately four weeks following glove provision.
Exclusion:
- Has a terminal illness, or other health or personal issues, such that the OT considers the patient's participation may be an undue burden.
- Has any other condition which could alter hand symptoms and function between assessments (eg stroke, multiple sclerosis)
- In early IA/RA or hand OA: received an intra-articular or intra-muscular steroid injection or started a new anti-inflammatory drug within the last 4 weeks
- In established RA only: started a new DMARD within the last 6 weeks
Sample size:
40 people from each of the: early IA or RA; and Hand OA, condition groups will be recruited. As this is a feasibility study no sample size has been calculated.
- Being tested
- Arthritis glove
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis gloveDevice
Isotoner three-quarter finger arthritis glove
| Study group | Role | What they receive |
|---|---|---|
| Arthritis glove | Early inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain Receives: Device: Arthritis glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand pain on movement
10 point numeric rating scale of hand pain during moderate activities (eg housework, gardening, work) with end points of no to severe pain
Measured: 4 weeks
Secondary outcomes (2)
Measure of Activity Performance in the Hand: patient reported outcome
patient reported outcome of hand function
Measured: 4 weeks
Grip Ability Test
objective measure of hand function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Hammond, University of Salford
- Investigators
- Alison Hammond, PhD, Principal investigator, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874067
- Sponsor's protocol ID
- C-GLOVES v2 26.7.13
- Other IDs
- 13/EM/0253
- Acronym
- C-GLOVES
- Status last verified
- Feb 2023
- First submitted
- 6 Jun 2013
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. A Pre-Test Post-test pilot trial of compression gloves in early inflammatory and rheumatoid arthritis. Rheumatology 54(S1):i111-112, 2015. doi:10.1093/rheumatology/kev089.045
Hammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. The Effect of Compression Gloves in Hand Osteoarthritis: A Pre-Pest-Test Trial. Arthritis and Rheumatism 66(11 Supplement): S436, 2014
Hammond A, Prior Y. Compression gloves for patients with hand arthritis (C-GLOVES): A feasibility study. Hand Ther. 2021 Mar;26(1):26-37. doi: 10.1177/1758998320986829. Epub 2021 Jan 12.
PubMed 37905193Hammond A, Prior Y. Arthritis glove provision in rheumatoid arthritis and hand osteoarthritis: A survey of United Kingdom rheumatology occupational therapists. Hand Ther. 2022 Mar;27(1):3-13. doi: 10.1177/17589983211060620. Epub 2022 Jan 5.
PubMed 37904793
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-GLOVES: an Evaluation of the Effectiveness of Compression Gloves in Arthritis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT01874067
- Acronym / sponsor ID
- C-GLOVES / C-GLOVES v2 26.7.13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jun 2013 (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.
This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand pain, swelling and stiffness. People find they help but there is little research testing this. Of the five small studies published: two found little or no benefit; one found similar effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if gloves work helps therapists and patients judge if they will help.
This is a feasibility study to help us plan a future trial testing if arthritis gloves work for people with arthritis. We aim to find out: the rate we can recruit people to the study; if OTs can assess people's hands and provide gloves as agreed; how many people do we need to take part in a trial; what do people think (if any) is the gloves' most important effect and how long should we test them for? We will analyse the data to see what effect the gloves have.
The study will last 12 months. People will get arthritis gloves as part of their usual care. The OTs have agreed a standard way of assessing and providing the gloves to ensure best practice across departments. The assessments include: difficulties using hands, pain and stiffness levels, and measuring hand and finger joint size and movement. People can take part if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter length gloves; can attend the usual 4 week review appointment for re-assessment; will allow us to use their anonymized hand assessments. We will also interview some people about their views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.
Detailed description
Design:
An observational study of usual care providing arthritis gloves with pre- and 4 weeks post-treatment assessment. Participants are screened and recruited (if eligible and consenting) as they attend for glove provision as part of routine care. (Participants are not randomly assigned).
Intervention:
Three-quarter length finger Isotoner glove(s) for one or both hands, as required. The participating OTs determine if patients meet their agreed criteria for gloves as part of usual care. Usually at the same appointment the OT then assesses for and provides these using the assessment and treatment protocols agreed by North West England College of Occupational Therapists Specialist Section - Rheumatology (NWCOTSS-R) members as part of their usual care. Four weeks later, patients attend a review appointment (as part of their usual care) for re-assessment of their hand(s), and to identify any effects the gloves have had and if any problems arose meaning glove wear should be stopped or the wear regimen altered. Normally the patient attends for two appointments only.
Occupational therapist (OT) training
The members of the NWCOTSS-R group agreed the glove provision criteria, hand assessment and treatment protocols and glove instruction sheet in order to improve standards of usual care in glove provision across Rheumatology OT departments. Prior to recruitment commencing, the participating OTs attended a training meeting to ensure they:
- performed the hand assessments (i.e. swelling, finger flexion and Grip Ability Test) reliably.
- Know how to correctly size and fit the gloves following training by an experienced Rheumatology OT
- understand the study procedures, know how to take study specific consent and complete study site documentation.
A standardised assessment kit and manual was provided to the OTs by the University research centre.
Study criteria:
Inclusion:
- Meet the criteria agreed by NWCOTSS-R members for receiving compression gloves as part of usual OT care.
- Adults with either:
- early inflammatory, probable or definite RA, diagnosed by a Rheumatology Consultant ii. hand OA, diagnosed by a GP, Consultant or Advanced Practitioner.
- Willing and able to wear three-quarter length Isotoner glove(s), following the glove fitting process.
- Willing to attend for the glove review appointment (part of usual care) approximately four weeks following glove provision.
Exclusion:
- Has a terminal illness, or other health or personal issues, such that the OT considers the patient's participation may be an undue burden.
- Has any other condition which could alter hand symptoms and function between assessments (eg stroke, multiple sclerosis)
- In early IA/RA or hand OA: received an intra-articular or intra-muscular steroid injection or started a new anti-inflammatory drug within the last 4 weeks
- In established RA only: started a new DMARD within the last 6 weeks
Sample size:
40 people from each of the: early IA or RA; and Hand OA, condition groups will be recruited. As this is a feasibility study no sample size has been calculated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthritis glove | – | Device: Arthritis gloveEarly inflammatory, rheumatoid or hand osteoarthritis with hand/wrist swelling and pain |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatology Occupational Therapy and Hand Therapy out-patient departments
Key inclusion criteria (1 listed)
- experiencing hand pain and swelling
Key exclusion criteria (1 listed)
- unable to give informed consent
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 |
|---|---|---|
| Arthritis gloveIsotoner three-quarter finger arthritis glove | Device | Arthritis glove |
Primary outcome
Hand pain on movement
Time frame: 4 weeks
10 point numeric rating scale of hand pain during moderate activities (eg housework, gardening, work) with end points of no to severe pain
2 secondary outcomes
Measure of Activity Performance in the Hand: patient reported outcome
Time frame: 4 weeks
Grip Ability Test
Time frame: 4 weeks
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 10 Feb 2023.
- BackgroundHammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. A Pre-Test Post-test pilot trial of compression gloves in early inflammatory and rheumatoid arthritis. Rheumatology 54(S1):i111-112, 2015. doi:10.1093/rheumatology/kev089.045
- BackgroundHammond A, Prior Y, Jones V, Dooley M, Hough Y, Jacklin A. The Effect of Compression Gloves in Hand Osteoarthritis: A Pre-Pest-Test Trial. Arthritis and Rheumatism 66(11 Supplement): S436, 2014
- Background: PubMed 37905193Hammond A, Prior Y. Compression gloves for patients with hand arthritis (C-GLOVES): A feasibility study. Hand Ther. 2021 Mar;26(1):26-37. doi: 10.1177/1758998320986829. Epub 2021 Jan 12.
- Background: PubMed 37904793Hammond A, Prior Y. Arthritis glove provision in rheumatoid arthritis and hand osteoarthritis: A survey of United Kingdom rheumatology occupational therapists. Hand Ther. 2022 Mar;27(1):3-13. doi: 10.1177/17589983211060620. Epub 2022 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
Alison Hammond, PhD principal investigator
University of Salford
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Arthritis and Rheumatoid Arthritis, run by University of Salford at 5 sites 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 1 inclusion and 1 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
Hand pain on movement (time frame: 4 weeks). 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 NCT01874067, which also lists 4 linked publications.
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 10 Feb 2023.