Trigger FingerNCT05383040
Percutaneous Release vs Steroid Injection for Trigger Finger
A study testing Percutaneous release in people with Trigger Finger, run by Armed Police Force Hospital, Nepal at 1 site in Nepal.
Trial summary
Trigger fingers (TF) is the common cause of pain and disturbed function of hand. Many studies show that percutaneous release of A1 pulley has better outcome than the steroid injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Percutaneous release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2022to 2 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 years and above
- Duration of symptoms :≥ 3 months
- Triggering in any of the digits of hand
- Trigger finger type II-IV based on Quinnell classification
Who cannot join
- There is prior treatment for trigger finger, or Trigger thumb
- There had been previous surgery or other hand pathology such as rheumatoid arthritis, osteoarthritis, Dupuytren's contracture and diabetic mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Percutaneous Release and Local Steroid Injection for the Treatment of Trigger Fingers: A Randomized Clinical Trial
Trigger fingers (TF) is the common cause of pain and disturbed function of hand. Many studies show that percutaneous release of A1 pulley has better outcome than the steroid injection. However, over the past many years, steroid injection has been considered as the choice of treatment after the failure of conservative treatment methods. The aim of this study is to assess the effect of percutaneous release of A1 pulley compared with the local Steroid injection in the treatment of trigger fingers.
This study is based on a randomized clinical trial to compare the effect of the percutaneous release of A1 pulley with steroid injection in trigger fingers. A total of 112 participants aged 18 years and above suffering from trigger fingers with failed conservative treatment will be intervened randomly (56 participants in injection group and 56 participants in percutaneous release group). The Quinnell's classification, VAS scoring system and active range of movement in the affected site will be assessed at the baseline and the same criteria will be at one month and three month as end line assessment. Statistical analyses will be performed using independent t-test and Mann Whitney U test to compare between the two means. The outcome of this study will help to guide the physicians to choose the better therapeutic approach among the patients suffering from trigger fingers.
Read the detailed description
Stenosing flexor tenosynovitis also known as trigger finger. It is a common clinical condition where there is locking and clicking during flexion and extension of the involved digit or even locking. The trigger ring finger is the first commonest, and the trigger thumb is the second commonest of trigger fingers. Flexor tendon gliding motion is dependent on a 'Critical Tendon Sheath Caliber Tolerance' which allows passage of flexor tendon through the A1 pulley in the Metacarpophalangeal joint.
The prevalence of trigger finger is 2 % in the general population, which is most common in women in the fifth or sixth decade of life. The possibility of a trigger finger is between 2 and 3% during the lifetime, which increases up to 10 % in diabetic patients. The trigger finger in diabetic patients suffered from worse renal function and glycemic control, along with a higher incidence of cardiovascular disease. The causes of Trigger finger are still not well known, some factors may increase the risk of developing the condition such as forceful hand activities (mechanical irritation, congenital and medical conditions (Diabetes and Rheumatoid arthritis). Trigger thumb is caused by thickening of flexor tendon gliding at the tendon A1 pulley interface or thickening of A1 pulley.
Diagnosis is primarily made based on physical examination. The patients often present with pain or clicking at the metacarpal head, which causes difficulty in holding or grasping objects. In most advanced cases, there is locking in flexion or extension position.
Nowadays, the morphological changes in the case of trigger fingers can be ruled out by high-resolution ultrasonography with a high-frequency transducer, and it has been found that the cut-off for pathological findings is a 20% increase in tendon thickness compared to the contralateral tendon. The average width and thickness of the A1 pulley are 7.1 mm and less than 1 mm respectively.
Treatment of Trigger fingers includes conservative such as splinting, oral medications, injection, and surgical management such as open release, and percutaneous release. Steroid injection has been serving us as a traditional way of injection therapy for many years for those who are not getting better with oral medications and physiotherapy. Steroid injection is effective because of its anti-inflammatory properties.
The first percutaneous release was performed in 1958 and the success rate was 100% without any reported complications. Percutaneous A1 pulley release has been the method of choice for patients who does not respond to conservative treatment (local steroid) with low complication rates.
There is a concern regarding percutaneous release in the thumb, where tendon sheath and neurovascular bundle are in proximity.
The technique of local steroid injection into the flexor sheath was described by Howard in 1953. It has become an accepted initial treatment for trigger fingers largely due to its use within the outpatient department and its low complication rate.
- Conditions
- Trigger Finger
- Being tested
- Percutaneous release
- Keywords
- Trigger fingers, Trigger digits, Steroid injection, Percutaneous release
- 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.
Percutaneous releaseProcedure or surgery
Percutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous release | Experimental | Percutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed. Receives: Procedure: Percutaneous release |
| Steroid injection | No intervention | The steroid injection mixed with 1 ml of methyl prednisone (40mg) with 0.5 ml of 2% plain lidocaine will be inserted into the flexor tendon sheath over the A1 pulley, which will also be performed in the operation theater for patient safety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility improvement
Compare the effects of percutaneous release versus steroid injection on functional mobility at baseline, one month and three months.
Measured: 3 months
Pain reduction
Compare the effects of percutaneous release versus steroid injection on pain reduction at baseline, one month and three months.
Measured: 3 months
Secondary outcomes (2)
Decrease in the thickness of the A1 pulley
Compare the effects of percutaneous release versus steroid injection on decrease in the thickness at baseline, one month and three months.
Measured: 3 months
Recurrence of problem within 3 months
Compare the effects of percutaneous release with steroid injection on problem recurrence in three months.
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 posted19 May 2022
- Study start1 Jun 2022
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A hospital-based randomized clinical trial study will be carried out to compare the effect of percutaneous release of A1 pulley with steroid injection in the treatment for trigger finger.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Police Force Hospital, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dev Ram Sunuwar, Armed Police Force Hospital, Nepal
- Investigators
- Mandeep Karki, MS, Principal investigator, Nepal Orthopedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383040
- Sponsor's protocol ID
- Trigger finger
- Status last verified
- Feb 2023
- First submitted
- 17 May 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore JS. Flexor tendon entrapment of the digits (trigger finger and trigger thumb). J Occup Environ Med. 2000 May;42(5):526-45. doi: 10.1097/00043764-200005000-00012.
PubMed 10824306Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.
PubMed 14599834Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.
PubMed 19468879Mineoka Y, Ishii M, Hashimoto Y, Yuge H, Toyoda M, Nakamura N, Katsumi Y, Fukui M. Trigger finger is associated with risk of incident cardiovascular disease in individuals with type 2 diabetes: a retrospective cohort study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e002070. doi: 10.1136/bmjdrc-2020-002070.
PubMed 33832915David M, Rangaraju M, Raine A. Acquired triggering of the fingers and thumb in adults. BMJ. 2017 Nov 30;359:j5285. doi: 10.1136/bmj.j5285. No abstract available.
PubMed 29191846Lunsford D, Valdes K, Hengy S. Conservative management of trigger finger: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):212-221. doi: 10.1016/j.jht.2017.10.016. Epub 2017 Dec 28.
PubMed 29290504Takahashi M, Sato R, Kondo K, Sairyo K. Morphological alterations of the tendon and pulley on ultrasound after intrasynovial injection of betamethasone for trigger digit. Ultrasonography. 2018 Apr;37(2):134-139. doi: 10.14366/usg.17038. Epub 2017 Jul 25.
PubMed 28870061Pan M, Sheng S, Fan Z, Lu H, Yang H, Yan F, E Z. Ultrasound-Guided Percutaneous Release of A1 Pulley by Using a Needle Knife: A Prospective Study of 41 Cases. Front Pharmacol. 2019 Mar 26;10:267. doi: 10.3389/fphar.2019.00267. eCollection 2019.
PubMed 30971922Bianchi S, Gitto S, Draghi F. Ultrasound Features of Trigger Finger: Review of the Literature. J Ultrasound Med. 2019 Dec;38(12):3141-3154. doi: 10.1002/jum.15025. Epub 2019 May 20.
PubMed 31106876LORTHIOIR J Jr. Surgical treatment of trigger-finger by a subcutaneous method. J Bone Joint Surg Am. 1958 Jul;40-A(4):793-5. No abstract available.
PubMed 13549516Blumberg N, Arbel R, Dekel S. Percutaneous release of trigger digits. J Hand Surg Br. 2001 Jun;26(3):256-7. doi: 10.1054/jhsb.2001.0569.
PubMed 11386779Park MJ, Oh I, Ha KI. A1 pulley release of locked trigger digit by percutaneous technique. J Hand Surg Br. 2004 Oct;29(5):502-5. doi: 10.1016/j.jhsb.2004.03.015.
PubMed 15336757Ragoowansi R, Acornley A, Khoo CT. Percutaneous trigger finger release: the 'lift-cut' technique. Br J Plast Surg. 2005 Sep;58(6):817-21. doi: 10.1016/j.bjps.2005.04.003.
PubMed 15936736Eastwood DM, Gupta KJ, Johnson DP. Percutaneous release of the trigger finger: an office procedure. J Hand Surg Am. 1992 Jan;17(1):114-7. doi: 10.1016/0363-5023(92)90125-9.
PubMed 1538091Lyu SR. Closed division of the flexor tendon sheath for trigger finger. J Bone Joint Surg Br. 1992 May;74(3):418-20. doi: 10.1302/0301-620X.74B3.1587893.
PubMed 1587893
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Percutaneous Release and Local Steroid Injection for the Treatment of Trigger Fingers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05383040
- Acronym / sponsor ID
- Trigger finger
- Conditions
- Trigger Finger
- Keywords
- Trigger fingers, Trigger digits, Steroid injection, Percutaneous release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Armed Police Force Hospital, NepalOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 19 May 2022 (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.
Trigger fingers (TF) is the common cause of pain and disturbed function of hand. Many studies show that percutaneous release of A1 pulley has better outcome than the steroid injection. However, over the past many years, steroid injection has been considered as the choice of treatment after the failure of conservative treatment methods. The aim of this study is to assess the effect of percutaneous release of A1 pulley compared with the local Steroid injection in the treatment of trigger fingers.
This study is based on a randomized clinical trial to compare the effect of the percutaneous release of A1 pulley with steroid injection in trigger fingers. A total of 112 participants aged 18 years and above suffering from trigger fingers with failed conservative treatment will be intervened randomly (56 participants in injection group and 56 participants in percutaneous release group). The Quinnell's classification, VAS scoring system and active range of movement in the affected site will be assessed at the baseline and the same criteria will be at one month and three month as end line assessment. Statistical analyses will be performed using independent t-test and Mann Whitney U test to compare between the two means. The outcome of this study will help to guide the physicians to choose the better therapeutic approach among the patients suffering from trigger fingers.
Detailed description
Stenosing flexor tenosynovitis also known as trigger finger. It is a common clinical condition where there is locking and clicking during flexion and extension of the involved digit or even locking. The trigger ring finger is the first commonest, and the trigger thumb is the second commonest of trigger fingers. Flexor tendon gliding motion is dependent on a 'Critical Tendon Sheath Caliber Tolerance' which allows passage of flexor tendon through the A1 pulley in the Metacarpophalangeal joint.
The prevalence of trigger finger is 2 % in the general population, which is most common in women in the fifth or sixth decade of life. The possibility of a trigger finger is between 2 and 3% during the lifetime, which increases up to 10 % in diabetic patients. The trigger finger in diabetic patients suffered from worse renal function and glycemic control, along with a higher incidence of cardiovascular disease. The causes of Trigger finger are still not well known, some factors may increase the risk of developing the condition such as forceful hand activities (mechanical irritation, congenital and medical conditions (Diabetes and Rheumatoid arthritis). Trigger thumb is caused by thickening of flexor tendon gliding at the tendon A1 pulley interface or thickening of A1 pulley.
Diagnosis is primarily made based on physical examination. The patients often present with pain or clicking at the metacarpal head, which causes difficulty in holding or grasping objects. In most advanced cases, there is locking in flexion or extension position.
Nowadays, the morphological changes in the case of trigger fingers can be ruled out by high-resolution ultrasonography with a high-frequency transducer, and it has been found that the cut-off for pathological findings is a 20% increase in tendon thickness compared to the contralateral tendon. The average width and thickness of the A1 pulley are 7.1 mm and less than 1 mm respectively.
Treatment of Trigger fingers includes conservative such as splinting, oral medications, injection, and surgical management such as open release, and percutaneous release. Steroid injection has been serving us as a traditional way of injection therapy for many years for those who are not getting better with oral medications and physiotherapy. Steroid injection is effective because of its anti-inflammatory properties.
The first percutaneous release was performed in 1958 and the success rate was 100% without any reported complications. Percutaneous A1 pulley release has been the method of choice for patients who does not respond to conservative treatment (local steroid) with low complication rates.
There is a concern regarding percutaneous release in the thumb, where tendon sheath and neurovascular bundle are in proximity.
The technique of local steroid injection into the flexor sheath was described by Howard in 1953. It has become an accepted initial treatment for trigger fingers largely due to its use within the outpatient department and its low complication rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A hospital-based randomized clinical trial study will be carried out to compare the effect of percutaneous release of A1 pulley with steroid injection in the treatment for trigger finger.
| Arm | Type | Receives |
|---|---|---|
| percutaneous release | Experimental | Procedure: Percutaneous releasePercutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed. |
| Steroid injection | No intervention | –The steroid injection mixed with 1 ml of methyl prednisone (40mg) with 0.5 ml of 2% plain lidocaine will be inserted into the flexor tendon sheath over the A1 pulley, which will also be performed in the operation theater for patient safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 years and above
- Duration of symptoms :≥ 3 months
- Triggering in any of the digits of hand
- Trigger finger type II-IV based on Quinnell classification
Key exclusion criteria (2 listed)
- There is prior treatment for trigger finger, or Trigger thumb
- There had been previous surgery or other hand pathology such as rheumatoid arthritis, osteoarthritis, Dupuytren's contracture and diabetic mellitus.
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 |
|---|---|---|
| Percutaneous releasePercutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed. | Procedure or surgery | percutaneous release |
Primary outcome
Functional mobility improvement
Time frame: 3 months
Compare the effects of percutaneous release versus steroid injection on functional mobility at baseline, one month and three months.
Pain reduction
Time frame: 3 months
Compare the effects of percutaneous release versus steroid injection on pain reduction at baseline, one month and three months.
2 secondary outcomes
Decrease in the thickness of the A1 pulley
Time frame: 3 months
Recurrence of problem within 3 months
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 27 Feb 2023.
- Results publication: PubMed 10824306Moore JS. Flexor tendon entrapment of the digits (trigger finger and trigger thumb). J Occup Environ Med. 2000 May;42(5):526-45. doi: 10.1097/00043764-200005000-00012.
- Results publication: PubMed 14599834Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.
- Results publication: PubMed 19468879Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.
- Results publication: PubMed 33832915Mineoka Y, Ishii M, Hashimoto Y, Yuge H, Toyoda M, Nakamura N, Katsumi Y, Fukui M. Trigger finger is associated with risk of incident cardiovascular disease in individuals with type 2 diabetes: a retrospective cohort study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e002070. doi: 10.1136/bmjdrc-2020-002070.
- Results publication: PubMed 29191846David M, Rangaraju M, Raine A. Acquired triggering of the fingers and thumb in adults. BMJ. 2017 Nov 30;359:j5285. doi: 10.1136/bmj.j5285. No abstract available.
- Results publication: PubMed 29290504Lunsford D, Valdes K, Hengy S. Conservative management of trigger finger: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):212-221. doi: 10.1016/j.jht.2017.10.016. Epub 2017 Dec 28.
- Results publication: PubMed 28870061Takahashi M, Sato R, Kondo K, Sairyo K. Morphological alterations of the tendon and pulley on ultrasound after intrasynovial injection of betamethasone for trigger digit. Ultrasonography. 2018 Apr;37(2):134-139. doi: 10.14366/usg.17038. Epub 2017 Jul 25.
- Results publication: PubMed 30971922Pan M, Sheng S, Fan Z, Lu H, Yang H, Yan F, E Z. Ultrasound-Guided Percutaneous Release of A1 Pulley by Using a Needle Knife: A Prospective Study of 41 Cases. Front Pharmacol. 2019 Mar 26;10:267. doi: 10.3389/fphar.2019.00267. eCollection 2019.
- Results publication: PubMed 31106876Bianchi S, Gitto S, Draghi F. Ultrasound Features of Trigger Finger: Review of the Literature. J Ultrasound Med. 2019 Dec;38(12):3141-3154. doi: 10.1002/jum.15025. Epub 2019 May 20.
- Results publication: PubMed 13549516LORTHIOIR J Jr. Surgical treatment of trigger-finger by a subcutaneous method. J Bone Joint Surg Am. 1958 Jul;40-A(4):793-5. No abstract available.
- Results publication: PubMed 11386779Blumberg N, Arbel R, Dekel S. Percutaneous release of trigger digits. J Hand Surg Br. 2001 Jun;26(3):256-7. doi: 10.1054/jhsb.2001.0569.
- Results publication: PubMed 15336757Park MJ, Oh I, Ha KI. A1 pulley release of locked trigger digit by percutaneous technique. J Hand Surg Br. 2004 Oct;29(5):502-5. doi: 10.1016/j.jhsb.2004.03.015.
- 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.
Mandeep Karki, MS principal investigator
Nepal Orthopedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous release in people with Trigger Finger, run by Armed Police Force Hospital, Nepal at 1 site in Nepal.
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 4 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: finished, as of the sponsor's last update on 27 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 1 site in Nepal. 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?
Functional mobility improvement (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05383040, which also lists 25 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 Feb 2023.