Investigating the effect of radial shockwave therapy in the treatment of trigger finger
Design
The randomized clinical trial has a control group, the randomization method is performed in the form of restricted randomization and random allocation rule.
The sample size in each group is 19 people.
Settings and conduct
The study population is the patients referred to the physical medicine and rehabilitation clinic of Firouzgar Hospital. In all patients outcome measures checked before treatment and after completing the 6-week treatment period and 3 months after the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with an age greater than or equal to 18 years and
- Trigger finger grade two or three
Exclusion criteria:
- Patients who have been previously treated with Physiotherapy, corticosteroids and surgery
- Patients with local infection, malignancy, rheumatoid arthritis, pregnancy and arrhythmia
- Patients with musculoskeletal problems or nerve damage in the upper limb
- Not using a splint during 6 weeks of treatment
Intervention groups
In one group of patients, it is prescribed for the treatment of trigger finger splint. The prescribed splint in these patients places the MCP joint in 15 degrees of flexion and the patient is taught to use it day and night (24 hours) for 6 weeks. During the treatment, in order to follow up the patients' use of the splint, the researcher calls them by phone.
In the other group, patients are treated with radial shockwave in 6 sessions with one-week intervals.
In this group, in addition to shockwave treatment, trigger finger splint is also prescribed for the patients, similar to the first group.
Main outcome variables
Frequency of triggering ،Severity of triggering ،Functional impact of triggering,Pain score,Disability of upper limb
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230405057829N1
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Simin Sajadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 375 2812
Email address
dr.sajadi_pmr@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Radial shockwave therapy in trigger finger treatment
Public title
Effect of Radial shockwave therapy in trigger finger treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Patients with trigger finger grade two or three
Exclusion criteria:
Patients who have been previously treated with PT, corticosteroids and surgery
Patients with local infection, malignancy, rheumatoid arthritis, pregnancy and arrhythmia
Patients with musculoskeletal problems or nerve injury in the upper limb
Not using a splint during 6 weeks of treatment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is performed as restricted randomization and random allocation rule. In this method, equal number of each group (according to the amount of sample size) are written on papers of the same size and design, numbers 1 and 2 (representing the first and second group) and inside non-transparent envelopes. that it is not possible to see inside the envelope) is placed and the sufferers are asked to choose one of them randomly after moving the envelopes.
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 of Iran University of Medical Sciences
Street address
Baharestan Square,Shafa hospital
City
Tehran
Province
Tehran
Postal code
1157637131
Approval date
2022-10-17, 1401/07/25
Ethics committee reference number
IR.IUMS.FMD.REC.1401.383
Health conditions studied
1
Description of health condition studied
Trigger Finger
ICD-10 code
M65.3
ICD-10 code description
Nodular tendinous disease
Primary outcomes
1
Description
The intensity of the patient's pain is based on scoring from one to ten
Timepoint
Before the treatment and after completing the 6-week treatment period and 3 months after the treatment
Method of measurement
How much the patient knows the intensity of his pain and gives a score to his current pain from 0 (no pain) to 10 (the most severe pain that a person can experience in his lifetime). We ask the patient to indicate his pain level on a special 10 cm ruler
2
Description
Frequency of triggering
Timepoint
Before the treatment and after completing the 6-week treatment period and 3 months after the treatment
Method of measurement
The patient gives a score from zero to ten on the number of times the trigger finger gets stuck. Zero is the least disorder and ten is the most severe condition.
3
Description
Functional impact of triggering
Timepoint
Before the treatment and after completing the 6-week treatment period and 3 months after the treatment
Method of measurement
The patient scores the dysfunction caused by trigger finger from 0 to 10. 0 is the least disorder and 10 is the most severe
4
Description
Severity of triggering
Timepoint
Before the treatment and after completing the 6-week treatment period and 3 months after the treatment
Method of measurement
The patient scores the severity of the locking of the trigger finger from zero to ten. Zero is the least disorder and ten is the most severe condition
5
Description
Disability of upper limb
Timepoint
Before the treatment and after completing the 6-week treatment period and 3 months after the treatment
Method of measurement
Quick dash questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are treated with radial shockwave in 6 sessions with one-week intervals, and the shockwave treatment protocol includes 1500 shocks, 2.5 bar energy and 15 Hz frequency. In this group, in addition to shockwave treatment for trigger finger patients A splint is also prescribed.
Category
Treatment - Devices
2
Description
Control group: In this group of patients, trigger finger splint is prescribed for treatment. The prescribed splint in these patients places the MCP joint in 15 degrees of flexion and the patient is taught to use it day and night (24 hours) for 6 weeks. During the treatment, in order to follow up the patients' use of the splint, the researcher calls them by phone
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Maede Mollaei
Street address
Firuzgar hospital,Behafarin street,valiasr square
City
tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۸۷۱۱
Phone
+98 21 8214 1000
Email
maedemolaei415@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein keivani
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?