De Quervain DiseaseNCT04384536
Evaluation of Effectiveness of Local Anesthetic Injection in Patients With De Quervain Tenosynovitis
A study testing Neural therapy application in people with De Quervain Disease, run by Hüma Bölük Şenlikci at 1 site in Turkey (Türkiye).
Trial summary
De Quervain tenosynovitis is the most common cause of lateral wrist pain. It occurs with stenosis of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal extensor compartment of wrist. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Neural therapy application
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Mar 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients are diagnosed clinically using the Finkelstein test (in which the patient flexes the thumb and wraps the fingers over thumb, then the physician stabilizes the forearm and ulnarly deviates the wrist)
- The presence of pain over the abductor pollicis longus and extensor pollicis brevis tendons is accepted as positivity
- Patients between 18-65 years and presence of positive Finkelstein test are included the study.
Who cannot join
- Patients are excluded from the study if they have chronic widespread or local musculoskeletal pain due to rheumatological (i.e., fibromyalgia, rheumatoid arthritis), neurological diseases (i.e., multiple sclerosis, cervical discopathy or plexopathy), trauma or surgery to the related region (wrist, elbow or hand), or are aged <18 years or >65 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başkent University Ankara Hospital
Ankara, 00650
About this study
Official title: Effectiveness of Neural Therapy in Patients With De Quervain Tenosynovitis
De Quervain tenosynovitis is the most common cause of lateral wrist pain. It occurs with stenosis of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal extensor compartment of wrist. When these muscles are contracted, thumb extension is observed, so repeated ulnar deviation and thumb extension exacerbates pain. It is seen more commonly in middle-aged females and in the dominant hand.
Although it has been shown that fibrous tissue deposits cause thickening of the tendon sheaths, the etiology of de Quervain tenosynovitis is unclear. The prevalence of de Quervain tenosynovitis has been reported to be 0.5% in males and 1.3% in females.
Read more
Diagnosis of de Quervain tenosynovitis is based on clinical examination. The Finkelstein test is the provocation of pain with wrist ulnar deviation. Plain radiography may be useful for differential diagnosis. Conservative treatment of rest, non-steroidal anti-inflammatory drugs (NSAID), and physical therapy is applied first, then there may be a need for corticosteroid injections, and in resistant cases, surgery.
Neural therapy (NT) is a type of regulatory therapy using local anesthesia for the management of chronic musculoskeletal pain. NT includes local therapy (eg,infiltration of trigger points) and segmental therapy (eg, sympathetic ganglia, nerve roots, and peripheral nerves) . To the best of our knowledge, the effect of neural therapy on patients with De Quervain tenosynovitis has not been previously evaluated. Therefore, the aim of this study was to highlight the effect of neural therapy on this condition.
Read the detailed description
In each session, 20 ml of local anesthetic (1:100 mixture of 10 mg/mL procaine) was used. Local injections, C5-T8 segmental injections, trigger point injections of the forearm muscles and stellate ganglion injections were applied in each session, using a 27-gauge, 4-6 cm needle. The local injection was applied first in the first extensor compartment at the point of maximal tenderness and was directed proximally toward the radial styloid (3 mL of the mixture). Then the forearm muscles were investigated by palpation to determine the trigger points. If any trigger point was detected, approximately 5 mL lidocaine was injected to that point. C5-T8 segmental injections were applied intradermally to each spinous process and to 0.5-2 cm lateral of each process on the affected side (approximately 0.25-0.5 ml per injection). Finally, the stellate ganglion injection was applied using Fischer's modified technique. The sternocleidomastoid muscle was palpated by the physician between the middle and distal third, gently pulling the muscle laterally with the neurovascular bundle. Following palpation of the anterior tubercle of the transverse process of the sixth cervical vertebra, the cervical spine was extended and rotated 45° to the opposite side. The needle entry point was 1 mm below the tubercle, then the needle was directed 45° caudally, 45° medially and 45° dorsally. If the aspiration was negative, 3mL procaine was injected
- Conditions
- De Quervain Disease
- Being tested
- Neural therapy application
- Keywords
- De Quervain tenosynovitis, Local anesthetics, neural therapy
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural therapy applicationProcedure or surgery
Local injections, C5-T8 segmental injections, trigger point injections of the forearm muscles and stellate ganglion injections are applied in each session, using a 27-gauge, 4-6 cm needle. The local injection is applied first in the first extensor compartment at the point of maximal tenderness and is directed proximally toward the radial styloid.trigger point is detected, approximately 5 mL lidocaine was injected to that point. C5-T8 segmental injections are applied intradermally to each spinous process and to 0.5-2 cm lateral of each process on the affected side. Finally, the stellate ganglion injection is applied using Fischer's modified technique.
| Study group | Role | What they receive |
|---|---|---|
| Neural therapy group | Experimental | Neural therapy group underwent local anesthetics injections by the same physician. Local injections, segmental injections and injection of trigger points of the forearm are done. The patients are evaluated at the beginning of the study and after 4 weeks of follow-up. Pre and post-treatment visual analog scale and Duruöz Hand Index scores are obtained. Receives: Procedure: Neural therapy application |
| Control group | No intervention | Control group used thumb spica splint and had rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
A 10-cm VAS was used by patients for the self-assessment of pain intensity associated with tenosynovitis. Patients were asked to score the level of pain severity on a scale marked from 0-10 where 0= no pain and 10= intolerable pain
Measured: a month follow-up
Duruöz Hand index (DHI)
The DHI is a self-reporting scale for the evaluation of hand functions, which was first developed in 1996 for patients with rheumatoid arthritis. It consists of 18 items in 5 domains of kitchen tasks, personal hygiene, dressing, office tasks and others. Each item is scored between 0-5, to give a total score of 0-90, with higher scores indicating increased hand disability
Measured: a month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jan 2020
- Primary completion15 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for De Quervain DiseaseStudies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hüma Bölük Şenlikci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hüma Bölük Şenlikci, Baskent University Ankara Hospital
- Investigators
- Hüma Bölük-Şenlikci, MD, Study director, Başkent University Medical School Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384536
- Sponsor's protocol ID
- 26379996/79
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Before publication it would not be appropriate to share data with other researchers
Publications
Ippolito JA, Hauser S, Patel J, Vosbikian M, Ahmed I. Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial. Hand (N Y). 2020 Mar;15(2):215-219. doi: 10.1177/1558944718791187. Epub 2018 Jul 30.
PubMed 30060681Pensak MJ, Bayron J, Wolf JM. Current treatment of de Quervain tendinopathy. J Hand Surg Am. 2013 Nov;38(11):2247-9; quiz 2250. doi: 10.1016/j.jhsa.2013.06.003. Epub 2013 Jul 24. No abstract available.
PubMed 23890846Kuo YL, Hsu CC, Kuo LC, Wu PT, Shao CJ, Wu KC, Wu TT, Jou IM. Inflammation is present in de Quervain Disease--correlation study between biochemical and histopathological evaluation. Ann Plast Surg. 2015 May;74 Suppl 2:S146-51. doi: 10.1097/SAP.0000000000000459.
PubMed 25650747Egli S, Pfister M, Ludin SM, Puente de la Vega K, Busato A, Fischer L. Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients. BMC Complement Altern Med. 2015 Jun 27;15:200. doi: 10.1186/s12906-015-0735-z.
PubMed 26115657
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neural Therapy in Patients With De Quervain Tenosynovitis
- ClinicalTrials.gov ID
- NCT04384536
- Acronym / sponsor ID
- 26379996/79
- Conditions
- De Quervain Disease
- Keywords
- De Quervain tenosynovitis, Local anesthetics, neural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hüma Bölük ŞenlikciUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 12 May 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.
De Quervain tenosynovitis is the most common cause of lateral wrist pain. It occurs with stenosis of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal extensor compartment of wrist. When these muscles are contracted, thumb extension is observed, so repeated ulnar deviation and thumb extension exacerbates pain. It is seen more commonly in middle-aged females and in the dominant hand.
Although it has been shown that fibrous tissue deposits cause thickening of the tendon sheaths, the etiology of de Quervain tenosynovitis is unclear. The prevalence of de Quervain tenosynovitis has been reported to be 0.5% in males and 1.3% in females.
Diagnosis of de Quervain tenosynovitis is based on clinical examination. The Finkelstein test is the provocation of pain with wrist ulnar deviation. Plain radiography may be useful for differential diagnosis. Conservative treatment of rest, non-steroidal anti-inflammatory drugs (NSAID), and physical therapy is applied first, then there may be a need for corticosteroid injections, and in resistant cases, surgery.
Neural therapy (NT) is a type of regulatory therapy using local anesthesia for the management of chronic musculoskeletal pain. NT includes local therapy (eg,infiltration of trigger points) and segmental therapy (eg, sympathetic ganglia, nerve roots, and peripheral nerves) . To the best of our knowledge, the effect of neural therapy on patients with De Quervain tenosynovitis has not been previously evaluated. Therefore, the aim of this study was to highlight the effect of neural therapy on this condition.
Detailed description
In each session, 20 ml of local anesthetic (1:100 mixture of 10 mg/mL procaine) was used. Local injections, C5-T8 segmental injections, trigger point injections of the forearm muscles and stellate ganglion injections were applied in each session, using a 27-gauge, 4-6 cm needle. The local injection was applied first in the first extensor compartment at the point of maximal tenderness and was directed proximally toward the radial styloid (3 mL of the mixture). Then the forearm muscles were investigated by palpation to determine the trigger points. If any trigger point was detected, approximately 5 mL lidocaine was injected to that point. C5-T8 segmental injections were applied intradermally to each spinous process and to 0.5-2 cm lateral of each process on the affected side (approximately 0.25-0.5 ml per injection). Finally, the stellate ganglion injection was applied using Fischer's modified technique. The sternocleidomastoid muscle was palpated by the physician between the middle and distal third, gently pulling the muscle laterally with the neurovascular bundle. Following palpation of the anterior tubercle of the transverse process of the sixth cervical vertebra, the cervical spine was extended and rotated 45° to the opposite side. The needle entry point was 1 mm below the tubercle, then the needle was directed 45° caudally, 45° medially and 45° dorsally. If the aspiration was negative, 3mL procaine was injected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural therapy group | Experimental | Procedure: Neural therapy applicationNeural therapy group underwent local anesthetics injections by the same physician. Local injections, segmental injections and injection of trigger points of the forearm are done. The patients are evaluated at the beginning of the study and after 4 weeks of follow-up. Pre and post-treatment visual analog scale and Duruöz Hand Index scores are obtained. |
| Control group | No intervention | –Control group used thumb spica splint and had rest |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients are diagnosed clinically using the Finkelstein test (in which the patient flexes the thumb and wraps the fingers over thumb, then the physician stabilizes the forearm and ulnarly deviates the wrist)
- The presence of pain over the abductor pollicis longus and extensor pollicis brevis tendons is accepted as positivity
- Patients between 18-65 years and presence of positive Finkelstein test are included the study.
Key exclusion criteria (1 listed)
- Patients are excluded from the study if they have chronic widespread or local musculoskeletal pain due to rheumatological (i.e., fibromyalgia, rheumatoid arthritis), neurological diseases (i.e., multiple sclerosis, cervical discopathy or plexopathy), trauma or surgery to the related region (wrist, elbow or hand), or are aged <18 years or >65 years
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 |
|---|---|---|
| Neural therapy applicationLocal injections, C5-T8 segmental injections, trigger point injections of the forearm muscles and stellate ganglion injections are applied in each session, using a 27-gauge, 4-6 cm needle. The local injection is applied first in the first extensor compartment at the point of maximal tenderness and is directed proximally toward the radial styloid.trigger point is detected, approximately 5 mL lidocaine was injected to that point. C5-T8 segmental injections are applied intradermally to each spinous process and to 0.5-2 cm lateral of each process on the affected side. Finally, the stellate ganglion injection is applied using Fischer's modified technique. | Procedure or surgery | Neural therapy group |
Primary outcome
Visual analog scale (VAS)
Time frame: a month follow-up
A 10-cm VAS was used by patients for the self-assessment of pain intensity associated with tenosynovitis. Patients were asked to score the level of pain severity on a scale marked from 0-10 where 0= no pain and 10= intolerable pain
Duruöz Hand index (DHI)
Time frame: a month follow-up
The DHI is a self-reporting scale for the evaluation of hand functions, which was first developed in 1996 for patients with rheumatoid arthritis. It consists of 18 items in 5 domains of kitchen tasks, personal hygiene, dressing, office tasks and others. Each item is scored between 0-5, to give a total score of 0-90, with higher scores indicating increased hand disability
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 13 May 2020.
- Background: PubMed 30060681Ippolito JA, Hauser S, Patel J, Vosbikian M, Ahmed I. Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial. Hand (N Y). 2020 Mar;15(2):215-219. doi: 10.1177/1558944718791187. Epub 2018 Jul 30.
- Background: PubMed 23890846Pensak MJ, Bayron J, Wolf JM. Current treatment of de Quervain tendinopathy. J Hand Surg Am. 2013 Nov;38(11):2247-9; quiz 2250. doi: 10.1016/j.jhsa.2013.06.003. Epub 2013 Jul 24. No abstract available.
- Background: PubMed 25650747Kuo YL, Hsu CC, Kuo LC, Wu PT, Shao CJ, Wu KC, Wu TT, Jou IM. Inflammation is present in de Quervain Disease--correlation study between biochemical and histopathological evaluation. Ann Plast Surg. 2015 May;74 Suppl 2:S146-51. doi: 10.1097/SAP.0000000000000459.
- Results publication: PubMed 26115657Egli S, Pfister M, Ludin SM, Puente de la Vega K, Busato A, Fischer L. Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients. BMC Complement Altern Med. 2015 Jun 27;15:200. doi: 10.1186/s12906-015-0735-z.
- Individual participant dataSharing planned: No. Before publication it would not be appropriate to share data with other researchers
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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.
Hüma Bölük-Şenlikci, MD study director
Başkent University Medical School 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 Neural therapy application in people with De Quervain Disease, run by Hüma Bölük Şenlikci at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 13 May 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 Turkey (Türkiye). 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?
Visual analog scale (VAS) (time frame: a month follow-up). 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 NCT04384536, which also lists 4 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 13 May 2020.