Assessing the immediate effect of two counter-force orthoses for improvement of sensori-motor abilities of the hand in patients with lateral elbow tendinopathy
Design
Cross-over Randomized controlled trial with 50 participants enrolled between Aug 2017 to Jan 2018.
Settings and conduct
This was a randomized controlled crossover study, during which participants acted as their own controls (no orthosis) and compare to two counterforce orthoses (including a forearm band and an elbow sleeve) in a single session. The order of intervention and testing conditions were randomized and determined by taking a concealed draw from a bag. The testing protocol was started after orthoses were fitted and 5 minutes acclimatization. Participants were given about 5 minutes rest and the crossed-over to the second orthosis. For all measurements, the test was explained and demonstrated to the participant.
Participants/Inclusion and exclusion criteria
Lateral elbow tendinopathy was diagnosed using three following criteria: 1) pain on palpation of the lateral epicondyle, 2) elbow pain aggravated with resisted wrist extension, and 3) pain on resistive middle finger extension. Participants tested positive in all three criteria were included. People with history of surgery, fracture, dislocation, or injection to the elbow less than 6 weeks prior were excluded.
Intervention groups
Two frequently used counterforce orthoses in lateral elbow tendinopathy were compared with “no orthosis” condition: forearm band and elbow sleeve .
Main outcome variables
Pain severity, elbow proprioception, hand grip strength, and finger dexterity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N1
Registration date:2018-05-17, 1397/02/27
Registration timing:retrospective
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
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
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-08-11, 1396/05/20
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
The immediate sensori-motor effects of elbow orthoses in people with lateral elbow tendinopathy: A randomized cross-over study
Public title
The sensori-motor effects of elbow orthoses in tennis elbow
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pain on palpation of the lateral epicondyle.
Elbow pain aggravated with resisted wrist extension.
Pain on resistive middle finger extension
Exclusion criteria:
People with history of surgery, fracture, dislocation, or injection to the elbow less than 6 weeks prior were excluded
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The order of intervention and testing conditions were randomized and determined by taking a concealed draw from a bag.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.MUI-REC-1396.3.216
Health conditions studied
1
Description of health condition studied
Tennis elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
Pain
Timepoint
5 minutes after each intervention was applied.
Method of measurement
The pain severity was measured using a 10-cm visual analogue scale (VAS) in which 0 represented “no pain” and 10 indicated “the most severe pain” .
2
Description
Hand grip strength
Timepoint
5 minutes after each intervention was applied.
Method of measurement
Pain-free grip on the involved side was measured using a digital handgrip dynamometer (YDM-110, Yagami Ltd, Tokyo, Japan). Each participant stood with shoulder in neutral, elbow in extension and forearm in neutral position of supination/pronation then slowly squeeze the dynamometer handle until they felt pain at elbow
3
Description
Elbow joint position sense
Timepoint
5 minutes after each intervention was applied.
Method of measurement
Elbow proprioception was evaluated by the measurement of joint position sense. For this purpose, the ability of active angle reproduction was measured at the involved elbow. The participant sat on a chair and the arm is kept undisturbed and parallel to the floor using an adjustable arm support attached to the chair’s handle. The participant’s eyes were closed during proprioception testing. The examiner kept the forearm and started slowly moving the elbow from 90º toward extension until elbow reached in 70º of flexion. The elbow was kept at 70º for 20 seconds and participant was asked to memorize this position. The elbow returned to 90º and participant was asked to reproduce the target angle (70º of flexion). The active angle reproduction test was also employed when elbow moving toward flexion direction. Participants were asked to move their elbow from 90º toward further flexion until reached target angle was set at 110º of flexion.
Secondary outcomes
1
Description
Finger dexterity
Timepoint
5 minutes after intervention was applied.
Method of measurement
The finger dexterity was evaluated using “nine-hole peg test”. The testing instrument consist of a wooden board with nine hole and a counterpart has a shallow round dish contained nine pegs. The hole-board was centered in front of participant and shallow dish was on the involved side. Participant took the pegs one by one and put them in the holes, as quickly as could. They then removed the pegs one by one and replaced them in the shallow round dish. The time was recorded using a stopwatch from the moment participant reach the first peg until the last peg was put back in the dish.
Intervention groups
1
Description
Intervention group: The forearm band was an 8-cm-wide neoprene band fitted 2.5 cm below the elbow. A double layered neoprene pad was incorporated in the forearm band to apply a direct pressure to the origin of the extensor muscles. The elbow strap had a 5-cm-wide non-elastic strap to adjust the pressure on the pad.
Category
Rehabilitation
2
Description
Intervention group: The elbow sleeve was a neoprene support circumferentially contained the arm approximately 15 cm above and below the elbow. The elbow sleeve was fitted on the arm using two 5-cm-wide non-elastic straps above and below the elbow. Both types of counterforce orthoses had a range of available sizes to accommodate different participants’ sizes.