Ulnar Neuropathy at ElbowNCT02986906
Perineural Injection Therapy for Ulnar Neuropathy at Elbow
A study testing 5% dextrose, 2cc 0.9% normal saline+3cc Triamcinolone (30mg) and Ultrasound in people with Ulnar Neuropathy at Elbow, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulnar Neuropathy at Elbow
- What is being tested?
- 5% dextrose, 2cc 0.9% normal saline+3cc Triamcinolone (30mg) and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2017to 30 Oct 2019
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
Who cannot join
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for ulnar neuropathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886
About this study
Official title: The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.
Read the detailed description
After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.
- Conditions
- Ulnar Neuropathy at Elbow
- Being tested
- 5% dextrose, 2cc 0.9% normal saline+3cc Triamcinolone (30mg), Ultrasound
- Keywords
- ulnar neuropathy at elbow, Dextrose, perineural injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% dextroseDrug
Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
2cc 0.9% normal saline+3cc Triamcinolone (30mg)Drug
Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve
UltrasoundDevice
The ultrasound was used for injection guidance
| Study group | Role | What they receive |
|---|---|---|
| 5% dextrose | Experimental | The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy Receives: Drug: 5% dextrose; Device: Ultrasound |
| 2cc 0.9% normal saline+3cc Triamcinolone (30mg) | Active comparator | The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg) Receives: Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg); Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pain on 1st, 3rd, 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Secondary outcomes (4)
Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection
Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Change from nerve conduction velocity on 1st, 3rd, 6th month after injection
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Change from cross-sectional area on 1st, 3rd, 6th month after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection
The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
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 Ulnar Neuropathy at ElbowStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
- Investigators
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986906
- Sponsor's protocol ID
- PIT for ulnar neuropathy
- Status last verified
- Nov 2019
- First submitted
- 6 Dec 2016
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.
PubMed 26218266Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.
PubMed 1518514Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
PubMed 21623291
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
- ClinicalTrials.gov ID
- NCT02986906
- Acronym / sponsor ID
- PIT for ulnar neuropathy
- Conditions
- Ulnar Neuropathy at Elbow
- Keywords
- ulnar neuropathy at elbow, Dextrose, perineural injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 8 Dec 2016 (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.
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.
Detailed description
After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% dextrose | Experimental | Drug: 5% dextrose, Device: UltrasoundThe perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy |
| 2cc 0.9% normal saline+3cc Triamcinolone (30mg) | Active comparator | Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg), Device: UltrasoundThe Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
Key exclusion criteria (8 listed)
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
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 |
|---|---|---|
| 5% dextroseUltrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve | Drug | 5% dextrose |
| 2cc 0.9% normal saline+3cc Triamcinolone (30mg)Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve | Drug | 2cc 0.9% normal saline+3cc Triamcinolone (30mg) |
| UltrasoundThe ultrasound was used for injection guidance | Device | 2cc 0.9% normal saline+3cc Triamcinolone (30mg), 5% dextrose |
Primary outcome
Change from pain on 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
4 secondary outcomes
Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Change from nerve conduction velocity on 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Change from cross-sectional area on 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
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 20 Nov 2019.
- Results publication: PubMed 26218266Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.
- Results publication: PubMed 1518514Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.
- Results publication: PubMed 21623291Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
- Individual participant dataSharing planned: Yes
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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.
Yung-Tsan Wu, MD principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General 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 5% dextrose, 2cc 0.9% normal saline+3cc Triamcinolone (30mg) and Ultrasound in people with Ulnar Neuropathy at Elbow, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 8 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 20 Nov 2019. 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 Taiwan. 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?
Change from pain on 1st, 3rd, 6th month after injection (time frame: Pre-treatment, 1st, 3rd, 6th month after 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 NCT02986906, 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 20 Nov 2019.