An interventional study of Neural therapy application in De Quervain Disease, sponsored by Hüma Bölük Şenlikci. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Hüma Bölük Şenlikci · Not applicable, Interventional, and Treatment
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.
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
30 studies on the registry are indexed under De Quervain Disease; 7 are open to participants now.
This study's enrollment of 36 is below the median of 55 across 26 interventional studies indexed under De Quervain Disease.
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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.
Procedure: Neural therapy application
Control group used thumb spica splint and had rest
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.
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
Time frame: 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
Time frame: a month follow-up
Plan to share: No — Before publication it would not be appropriate to share data with other researchers
Ran from Jan 2020 to primary completion in Mar 2020, 2 months.
Of 16 interventional studies with no phase under De Quervain Disease, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 28. This study's 2 months is below that.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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