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Evaluation of Effectiveness of Local Anesthetic Injection in Patients With De Quervain Tenosynovitis

Primary Purpose

De Quervain Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neural therapy application
Sponsored by
Hüma Bölük Şenlikci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for De Quervain Disease focused on measuring De Quervain tenosynovitis, Local anesthetics, neural therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- 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

Sites / Locations

  • Başkent University Ankara Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neural therapy group

Control group

Arm Description

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.

Control group used thumb spica splint and had rest

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2020
Last Updated
May 12, 2020
Sponsor
Hüma Bölük Şenlikci
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1. Study Identification

Unique Protocol Identification Number
NCT04384536
Brief Title
Evaluation of Effectiveness of Local Anesthetic Injection in Patients With De Quervain Tenosynovitis
Official Title
Effectiveness of Neural Therapy in Patients With De Quervain Tenosynovitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hüma Bölük Şenlikci

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
Keywords
De Quervain tenosynovitis, Local anesthetics, neural therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neural therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group used thumb spica splint and had rest
Intervention Type
Procedure
Intervention Name(s)
Neural therapy application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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
Title
Duruöz Hand index (DHI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hüma Bölük-Şenlikci, MD
Organizational Affiliation
Başkent University Medical School Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Başkent University Ankara Hospital
City
Ankara
ZIP/Postal Code
00650
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Before publication it would not be appropriate to share data with other researchers
Citations:
PubMed Identifier
30060681
Citation
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.
Results Reference
background
PubMed Identifier
23890846
Citation
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.
Results Reference
background
PubMed Identifier
25650747
Citation
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.
Results Reference
background
PubMed Identifier
26115657
Citation
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.
Results Reference
result

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Evaluation of Effectiveness of Local Anesthetic Injection in Patients With De Quervain Tenosynovitis

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