A comparison between thumb spica cast and Corticosteroid injection vs. Corticosteroid injection in pain and functional outcomes of patients with De Quervain disease.
(1) Objectives: A comparison between thumb spica cast and Corticosteroid injection vs. Corticosteroid injection in treatment of patients with de Quervain disease.(2) Design: Randomized clinical trial. (3)Setting and conduct: Group A will receive thumb spica cast for 3 weeks and "Methyl-prednisolon acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% (60 mg) will be injected in maximal point tenderness, In group B "Methyl-prednisolon acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% (60 mg) will be injected. VAS and Quick DASH questionnaires will completed again after 3 weeks. Also, each patient will fill demographic questionnaire including age, gender, first refer time, involved hand, dominant hand and characteristic of disease. (4) Inclusion criteria: All patients should have 4 criteria: Pain at the radial wrist; Tenderness at the first dorsal extensor compartment; A positive Finkelstein test; VAS score more than 6. Exclusion criteria: Pregnancy and history of rheumatoid arthritis. (5) Intervention: Intervention group: Thumb spica cast and Corticosteroid injection, Control group: Corticosteroid injection. (6) Main outcome measures: primary outcome is Lack of the 4 criteria: Pain at the radial wrist; Tenderness at the first dorsal extensor compartment; A positive Finkelstein test; and VAS score more than 6 will be considered as successful treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109177274N2
Registration date:2012-02-01, 1390/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2011-12-06, 1390/09/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between thumb spica cast and Corticosteroid injection vs. Corticosteroid injection in pain and functional outcomes of patients with De Quervain disease.
Public title
A comparison between casting and Corton injection vs. Corton injection in treatment of patients with wrist tendinitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients should have 4 criteria: Pain at the radial wrist; Tenderness at the first dorsal extensor compartment; A positive Finkelstein test; and VAS score more than 6.
Exclusion criteria: Pregnancy; and history of rheumatoid arthritis.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue Rasht Guilan Iran, Islamic Republic Of
City
Rasht
Postal code
Approval date
2011-12-01, 1390/09/10
Ethics committee reference number
1901055802
Health conditions studied
1
Description of health condition studied
de Quervain's tenosynovitis
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
successful treatment that explained as lack of the three criteria: 1) Pain at the radial wrist. 2) Tenderness at the first dorsal extensor compartment. 3) A positive Finkelstein test.
Timepoint
refer time and 3 weeks after treatment
Method of measurement
History and physical examination
Secondary outcomes
1
Description
pain severity
Timepoint
before treatment and 3 weeks after treatment
Method of measurement
value-added service (VAS) score
2
Description
disability of elbow score
Timepoint
before treatment and 3 weeks after treatment
Method of measurement
The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)
Intervention groups
1
Description
Intervention Group: All patients in this group will be provided with one dose injection of "Methyl-prednisolon acetate" 40 milligrams plus 1 milliliter of "lidocaine"2 %( 60 milligrams) in the maximal point tenderness. After injection, all involved wrists will be immobilized using fiberglass thumb spica casts.
Category
Treatment - Other
2
Description
Control group: All patients in this group will be provided with one dose injection of "Methyl-prednisolon acetate" 40 milligrams plus 1 milliliter of "lidocaine"2% (60 milligrams) in the maximal point tenderness.