Trigger FingerEarly Phase 1NCT04645303
Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger
A Early Phase 1 study testing hyaluronic acid (20 mg/2 mL) and Triamcinolone acetonide 10mg/ml in people with Trigger Finger, run by Dubai Health Authority at 1 site in United Arab Emirates.
Trial summary
The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- hyaluronic acid (20 mg/2 mL) and Triamcinolone acetonide 10mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 6 Nov 2020to 4 Jun 2021
- Phase
- Early Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years)
- Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound.
Who cannot join
- Quinnell's classification grade IV (contracture)
- Prior injection within 6 months
- Prior operation of the affected finger
- Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and
- History of diabetes, hypothyroidism, and
- Rheumatic or connective tissue disease
Show all 10Show fewer
- Allergy to triamcinolone or hyaluronic acid
- Pregnancy
- Secondary triggering e.g. Trauma, infection
- Trigger finger symptoms duration >6 months
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Hospital- Dubai Health Authority
Dubai
442195718 ext. 00971, mmabdulla@dha.gov.ae
Sahar Khalil, SSR
About this study
Official title: Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study
The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance
Read the detailed description
A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance
- Conditions
- Trigger Finger
- Being tested
- hyaluronic acid (20 mg/2 mL), Triamcinolone acetonide 10mg/ml
- Keywords
- Trigger finger, Hyaluronic Acid, Corticosteroid, Ultrasound-guided injection
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid (20 mg/2 mL)Drug
Also called Hyalgan 20 mg in 2 ML Prefilled Syringe
A1-Pulley infiltration for trigger finger
Triamcinolone acetonide 10mg/mlDrug
Also called Kenalog 10 mg/ml
A1-Pulley infiltration for trigger finger
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | 1mL of hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1-pulley. Receives: Drug: hyaluronic acid (20 mg/2 mL) |
| Triamcinolone acetonide | Active comparator | 1 mL of Triamcinolone acetonide 10mg/ml infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1 pulley. Receives: Drug: Triamcinolone acetonide 10mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quinnell trigger finger grading system:
Change in Quinnell grading overtime within 3 months after injection. Trigger fingers are rated as follows: Grade 0: normal finger movements, Grade 1: uneven finger movements, Grade 2: actively correctable triggering, Grade 3: passively correctable triggering, and Grade 4: locked digit.
Measured: 1 and 3 months post-injection
Secondary outcomes (6)
Visual analogue scale (VAS) of pain
Change in pain Visual analogue scale will be recorded. The patient marks on the 100 mm in length line the point that he/she feels to represent his/her perception of pain at the current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks ( a higher score indicates greater pain intensity). Categorization of none, mild, moderate and severe pain will be also used (none = 0, mild = 1-4, moderate = 5-6, and severe = 7-10).
Measured: 1 and 3 months post-injection
Frequency of tender trigger nodules
Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation
Measured: 1 and 3 months post-injection
The Quick Disability of the Arm, Shoulder and Hand score
Patients will be asked to fill a questionnaire form. It is an 11-item form that assesses the upper limb function on a scale of 1-5, with scores ranging from 11 to 55, with the higher scores representing more disability and worse upper limb function.
Measured: 1 and 3 months post-injection
Changes in Grip strength
Measured by the dynamometer strength test (Jamar grip dynamometer)
Measured: 1 and 3 months post-injection
Patient satisfaction with therapy
Participating patients will be asked to classify their result into 1 of 4 categories: (1) complete resolution of symptoms, (2) improved result, but incomplete resolution of symptoms, not warranting further treatment, (3) partial response, but unsatisfactory, warranting further treatment, and (4) no response.
Measured: 1 and 3 months post-injection
Ultrasound evaluation of A1-Pulley
Detailed ultrasonography evaluation of A1-Pulley. Comparing the A1-Pulley ultrasonographic parameters over 3 months after injection (at the follow-up appointment)
Measured: 1 and 3 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start6 Nov 2020
- Primary completion5 Apr 2021 (estimated)
- Study completion4 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dubai Health Authority
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sahar Said Khalil, Dubai Health Authority
- Investigators
- Sahar S Khalil, SSR, Principal investigator, Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospitalMohamed M Abdulla, Consultant, Study chair, Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645303
- Sponsor's protocol ID
- DSREC-12/2019_03
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu DH, Tsai MW, Lin SH, Chou CL, Chiu JW, Chiang CC, Kao CL. Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2120-7. doi: 10.1016/j.apmr.2015.08.421. Epub 2015 Sep 1.
PubMed 26340807Callegari L, Spano E, Bini A, Valli F, Genovese E, Fugazzola C. Ultrasound-guided injection of a corticosteroid and hyaluronic acid: a potential new approach to the treatment of trigger finger. Drugs R D. 2011;11(2):137-45. doi: 10.2165/11591220-000000000-00000.
PubMed 21545190Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014:783632. doi: 10.1155/2014/783632. Epub 2014 May 8.
PubMed 24895610
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04645303
- Acronym / sponsor ID
- DSREC-12/2019_03
- Conditions
- Trigger Finger
- Keywords
- Trigger finger, Hyaluronic Acid, Corticosteroid, Ultrasound-guided injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dubai Health AuthorityOther government
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 5 Apr 2021 (estimated)
- Study completion
- 4 Jun 2021 (estimated)
- First posted
- 27 Nov 2020 (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 aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance
Detailed description
A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Drug: hyaluronic acid (20 mg/2 mL)1mL of hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1-pulley. |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone acetonide 10mg/ml1 mL of Triamcinolone acetonide 10mg/ml infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1 pulley. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (>18 years)
- Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound.
Key exclusion criteria (10 listed)
- Quinnell's classification grade IV (contracture)
- Prior injection within 6 months
- Prior operation of the affected finger
- Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and
- History of diabetes, hypothyroidism, and
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 |
|---|---|---|
| hyaluronic acid (20 mg/2 mL)Also: Hyalgan 20 mg in 2 ML Prefilled SyringeA1-Pulley infiltration for trigger finger | Drug | Hyaluronic acid |
| Triamcinolone acetonide 10mg/mlAlso: Kenalog 10 mg/mlA1-Pulley infiltration for trigger finger | Drug | Triamcinolone acetonide |
Primary outcome
Change in Quinnell trigger finger grading system:
Time frame: 1 and 3 months post-injection
Change in Quinnell grading overtime within 3 months after injection. Trigger fingers are rated as follows: Grade 0: normal finger movements, Grade 1: uneven finger movements, Grade 2: actively correctable triggering, Grade 3: passively correctable triggering, and Grade 4: locked digit.
6 secondary outcomes
Visual analogue scale (VAS) of pain
Time frame: 1 and 3 months post-injection
Frequency of tender trigger nodules
Time frame: 1 and 3 months post-injection
The Quick Disability of the Arm, Shoulder and Hand score
Time frame: 1 and 3 months post-injection
Changes in Grip strength
Time frame: 1 and 3 months post-injection
Patient satisfaction with therapy
Time frame: 1 and 3 months post-injection
Ultrasound evaluation of A1-Pulley
Time frame: 1 and 3 months post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Background: PubMed 26340807Liu DH, Tsai MW, Lin SH, Chou CL, Chiu JW, Chiang CC, Kao CL. Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2120-7. doi: 10.1016/j.apmr.2015.08.421. Epub 2015 Sep 1.
- Background: PubMed 21545190Callegari L, Spano E, Bini A, Valli F, Genovese E, Fugazzola C. Ultrasound-guided injection of a corticosteroid and hyaluronic acid: a potential new approach to the treatment of trigger finger. Drugs R D. 2011;11(2):137-45. doi: 10.2165/11591220-000000000-00000.
- Background: PubMed 24895610Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014:783632. doi: 10.1155/2014/783632. Epub 2014 May 8.
- Individual participant dataSharing planned: No
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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.
Sahar S Khalil, SSR principal investigator
Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospital
Mohamed M Abdulla, Consultant study chair
Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hyaluronic acid (20 mg/2 mL) and Triamcinolone acetonide 10mg/ml in people with Trigger Finger, run by Dubai Health Authority at 1 site in United Arab Emirates.
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 10 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 27 Nov 2020. 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 Arab Emirates. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sahar S Khalil, SSR (00971557557453, sskhalil@dha.gov.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quinnell trigger finger grading system: (time frame: 1 and 3 months post-injection). 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 NCT04645303, which also lists 3 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 27 Nov 2020.