The immediate effects of two splinting methods on pain and hand function in people with triangular fibrocartilage complex injury: a randomized crossover study
The objective of this study is to compare the effectiveness of two types of splints, including short cock-up as commonly used static orthosis for the lesion and a newly-design splint (hinged ulnar gutter) on wrist pain and hand function in people with degenerative lesions of triangular fibrocartilage complex.
Design
This is a crossover clinical trial. The sample size was determined based on the previous similar studies and set at 20 participants. All participants were put in a single group and received interventions in a random order. Randomization of intervention was determined by drawing a concealed envelop from a bag.
Settings and conduct
Participants will be recruited from outpatient clinic in Alzahra hospital, Isfahan, Iran through a convenience sampling method.
Participants/Inclusion and exclusion criteria
Inclusion Criterion of the study includes the presence of a damage to triangular fibrocartilage complex of the wrist.
Exclusion Criteria of the study include taking nonsteroidal anti-inflammatory drugs, a history of corticosteroid injections, history of fractures in the forearm and wrist and receiving any concurrent treatment for the lesion.
Intervention groups
In this study, four conditions are allocated to each participants which include the use of a short cock-up, the use of a new wrist splint (hinged ulnar gutter) as the study interventions, and the use of a wristband (placebo) and without a splint as control groups.
Main outcome variables
Pain severity, hand function, grip strength, wrist weight bearing tolerance, and range of motion for the wrist and forearm complex.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N9
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-19, 1399/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effects of two splinting methods on pain and hand function in people with triangular fibrocartilage complex injury: a randomized crossover study
Public title
The immediate effects of two hand splints in people with triangular fibrocartilage complex injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Positive ulnocarpal stress sign
Ulnar side wrist pain because of ulnocarpal abutment syndrome
Exclusion criteria:
Taking NSAIDs medications
Corticosteroid injection
History of wrist and forearm fracture
Receiving concurrent treatments for the lesion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.475
Health conditions studied
1
Description of health condition studied
degenerative injury of triangular fibrocartilage complex
ICD-10 code
S64
ICD-10 code description
Injury of nerves at wrist and hand level
Primary outcomes
1
Description
Pain severity
Timepoint
All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving interventions.
Method of measurement
Pain intensity will be measured using visual analogue scale. Participants indicate their pain level on a 10 cm scale.
2
Description
range of motions at the wrist
Timepoint
All interventions will be done in a session and outcomes will be measured 10 minutes after receiving interventions.
Method of measurement
The passive range of motion will be measured using a digital goniometer.
3
Description
The wrist weight bearing tolerance
Timepoint
All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving trial interventions.
Method of measurement
Participants push on a weight recording scale with the palmar surface of the hand.
4
Description
Hand grip strength
Timepoint
All interventions will be allocated in a session and outcomes will be measured 10 minutes after receiving trial interventions.
Method of measurement
Hand grip on the involved side will be measured using a digital handgrip dynamometer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The short cockup splint made from thermoplastic sheet. This rigid splint covers the volar surface of the hand from the proximal palmar crease to two-third of forearm area. Thumb freely moves in this splint. This splint is custom made for each participant. Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.
Category
Treatment - Devices
2
Description
Intervention group: The hinged ulnar gutter splint consists of two thermoplastic bars placed on the hand and forearm area. This splint fits over ulnar side of the hand and prevents the ulnar deviation of the wrist. The sagital motions of the wrist and thumb movements are not restricted. This splint is custom made for each participant. Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.
Category
Treatment - Devices
3
Description
Control group: The elastic wrist support which covers the middle area of the forearm to palmar surface of the hand and does not apply any mechanical restriction for motions in the hand and forearm.This splint is custom fitted for each participant. Each participant will be given about ten minutes to be accommodated with device then measurements will be carried out while device is worn.