Osteoarthritis ThumbNCT03327480
The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis
A study testing orthosis in people with Osteoarthritis Thumb, run by Diskapi Teaching and Research Hospital.
Trial summary
The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Nov 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being aged between 18 and 70
- Grade 1 or 2 thumb osteoarthritis
Who cannot join
- The other hand disorders such as fracture and carpal tunnel syndrome
- Previous hand surgery
About this study
Official title: The Effects of Hand Orthosis in Thumb Osteoarthritis
The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis
Read the detailed description
The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.
- Conditions
- Osteoarthritis Thumb
- Being tested
- orthosis
- Keywords
- osteoarthritis thumb, orthosis, functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthosisOther
Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis
| Study group | Role | What they receive |
|---|---|---|
| neoprene CMC orthosis | Experimental | We will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2 Receives: Other: orthosis |
| thermoplastic CMC orthosis | Experimental | We will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2 Receives: Other: orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUSCAN (Australian Canadian Oateoarthritis Hand Index)
This scale is used to assess of pain, disability and stiffness. Change is being assesed. Total score is ranged between 0-90.
Measured: before the treatment, end of the sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Can, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327480
- Sponsor's protocol ID
- Aslı Can
- Status last verified
- Oct 2017
- First submitted
- 14 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hand Orthosis in Thumb Osteoarthritis
- ClinicalTrials.gov ID
- NCT03327480
- Acronym / sponsor ID
- Aslı Can
- Conditions
- Osteoarthritis Thumb
- Keywords
- osteoarthritis thumb, orthosis, functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 31 Oct 2017 (actual)
- 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.
The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis
Detailed description
The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled prospective trial
| Arm | Type | Receives |
|---|---|---|
| neoprene CMC orthosis | Experimental | Other: orthosisWe will prescribe a neopren CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2 |
| thermoplastic CMC orthosis | Experimental | Other: orthosisWe will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being aged between 18 and 70
- Grade 1 or 2 thumb osteoarthritis
Key exclusion criteria (2 listed)
- The other hand disorders such as fracture and carpal tunnel syndrome
- Previous hand surgery
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 |
|---|---|---|
| orthosisGroup 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis | Other | neoprene CMC orthosis, thermoplastic CMC orthosis |
Primary outcome
AUSCAN (Australian Canadian Oateoarthritis Hand Index)
Time frame: before the treatment, end of the sixth week
This scale is used to assess of pain, disability and stiffness. Change is being assesed. Total score is ranged between 0-90.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing orthosis in people with Osteoarthritis Thumb, run by Diskapi Teaching and Research Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
AUSCAN (Australian Canadian Oateoarthritis Hand Index) (time frame: before the treatment, end of the sixth week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2017.