NCT04384536

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 8, 2020

Last Update Submit

May 12, 2020

Conditions

Keywords

De Quervain tenosynovitisLocal anestheticsneural therapy

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    a month follow-up

Study Arms (2)

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.

Procedure: Neural therapy application

Control group

NO INTERVENTION

Control group used thumb spica splint and had rest

Interventions

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.

Neural therapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University Ankara Hospital

Ankara, 00650, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 30060681BACKGROUND
  • Pensak 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.

    PMID: 23890846BACKGROUND
  • Kuo 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.

    PMID: 25650747BACKGROUND
  • Egli 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.

MeSH Terms

Conditions

De Quervain Disease

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Hüma Bölük-Şenlikci, MD

    Başkent University Medical School Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

January 1, 2020

Primary Completion

March 15, 2020

Study Completion

March 30, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Before publication it would not be appropriate to share data with other researchers

Locations