Effectiveness of splinting in the treatment of trigger finger
| ISRCTN | ISRCTN77451014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77451014 |
- Submission date
- 21/09/2022
- Registration date
- 28/09/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aim
Trigger finger is a common clinical disorder that affects about 2.6% of the general population and is characterized by clicking and/or catching during finger movement. A trigger finger often results in pain and functional limitations, which often affect one’s performance in activities of daily living, work, and leisure. Hand therapy and splinting offer alternative options for patients who do not wish to endure steroid injections or surgery. Hand therapy intervention and splinting are non-invasive and may provide relief for the idiopathic trigger finger. However, the evidence for their effectiveness remains limited. The aim of the study is to evaluate the effect of hand therapy in comparison to hand therapy and the use of a splint in the treatment of trigger fingers.
Who can participate?
Individuals with a trigger finger
What does studying involve?
An occupational therapist assesses the hand’s movement and pain and will provide intervention (either a finger splint or an exercise program). The study will run in Kuwait, and each participant will be followed for six months
What are the benefits and risks of taking part in this study?
This study will help us understand which treatment method is more effective in treating trigger fingers. There are no risks to participating in this study.
Where is the study run from?
Physical Medicine & Rehabilitation Hospital (Kuwait)
When is the study starting and how long is it expected to run for?
September 2020 to August 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammed Sh. Nadar (Kuwait)
mohammed.nadar@ku.edu.kw
Contact information
Principal Investigator
Occupational Therapy Department
Faculty of Allied Health Sciences
Kuwait University
Jabriah
00000
Kuwait
 ORCID ID |
0000-0003-4281-5630 |
|---|---|
| Phone | +965 2463 3491 |
| mohammed.nadar@ku.edu.kw |
Study information
| Study design | Double-blind randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Splinting versus exercise for the treatment of adult idiopathic trigger fingers |
| Study objectives | Splinting is more effective than hand therapy in treating adult idiopathic trigger finger |
| Ethics approval(s) | Approved 25/04/2022, Kuwait University Health Sciences Center Ethical Committee (Centre for Research Support & Conferences, Office of the Vice Dean for Research & Postgraduate Studies, HSC, Faculty of Medicine, P.O. Box 24923, Safat 13110, Kuwait; +965 24634524; hsc.ethicalcommitee@ku.edu.kw), ref: VDR/EC – 4019 |
| Health condition(s) or problem(s) studied | Idiopathic trigger finger |
| Intervention | The study has two groups: 1. The hand therapy control group 2. The experimental group, with splinting of the proximal interphalangeal (PIP) joint of the involved finger, in addition to the hand therapy program. A simple randomization procedure of computer-generated random numbers was used to assign patients to hand therapy alone versus hand therapy in combination with joint blocking splinting trial arms. The participants from both groups were required to attend one session of therapy per week, for six consecutive weeks, in addition to following a hand therapy home program. The participants were instructed to perform their therapy program three times a day as a home program. For the experimental splint group, the participants received a static ready-made Oval-8 splint that immobilizes the PIP joint of the involved digit at approximately zero degrees, while maintaining the metacarpophalangeal (MCP) and distal interphalangeal (DIP) joints unrestricted. The PIP joint was immobilized day and night for 6 weeks. The splint allowed full movement of the MCP and DIP joints. In addition to the splint, the experimental group received the same hand therapy intervention as the control group. At a four-month follow-up, the discharged participants were asked to return to the clinic for a final assessment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Proximal interphalangeal joint blocking splint |
| Primary outcome measure | The outcome measures were collected at baseline, 6 weeks, and 4 months: 1. Pain measured using a Numeric Pain Rating Scale (NPRS) 2. Severity of triggering measured using Green's classification of triggering 3. Upper extremity function in daily life activities measured using the short-form version of the Disabilities of the Arm Shoulder and Hand (QuickDASH). |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2020 |
| Completion date | 30/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 49 |
| Key inclusion criteria | 1. Confirmed clinical diagnosis of trigger finger at the A1 pulley 2. Affecting a single digit 3. Trigger finger of idiopathic origin 4. Green’s grade 2 or 3 |
| Key exclusion criteria | 1. Trigger thumb 2. Multiple digit involvements 3. Presence of an associated condition (i.e., diabetes mellitus, de Quervain's tenosynovitis, carpal tunnel syndrome, osteoarthritis, rheumatoid arthritis, gout, or hypothyroidism) 4. Caused by trauma (i.e., presence of chronic trauma or repetitive strain) 5. Use of a nonsteroidal anti-inflammatory drug (NSAID) 6. Previous treatments for the involved trigger digit |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 15/08/2022 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Andalous
00000
Kuwait
Sponsor information
University/education
Fourth Ring Rd
Jabriya
00000
Kuwait
| Phone | +965 24633489 |
|---|---|
| naser.alotaibi@ku.edu.kw | |
| Website | http://kuweb.ku.edu.kw/ku/index.htm |
"ROR" |
https://ror.org/021e5j056 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planning publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon reasonable request from the study author (Mohammed Nadar, mohammed.nadar@ku.edu.kw). The data can be available in Excell format, with no time restriction, to any researcher. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/10/2023 | 29/12/2023 | Yes | No |
Editorial Notes
29/12/2023: Publication reference added.
28/09/2022: Trial's existence confirmed by the Kuwait University Health Sciences Center Ethical Committee.
