Comparison of the effect of virtual reality and conventional proprioceptive training in neck region on pain, functional variables and balance in patients with cervical radiculopathy
Comparison of the effect of virtual reality and conventional proprioceptive training in neck region on pain, functional variables and balance in patients with cervical radiculopathy
Design
A randomized clinical trial Sampling allocated in 3 groups with 15 subjects, assessor blind and block randomization
Settings and conduct
45 patients will be randomly assigned to conventional or virtual reality based exercises group or control group. The virtual reality group will perform the computer game. The stages of the game are designed easy to hard sequentially. Movement and position sense, gaze stability, head-eye coordination exercises will be performed by patients in conventional group. all groups will perform control group exercises in 2 sets of 8 repetitions and will mark in their daily check list. Exercise regimes are of 10 sessions each lasting 20 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 40-60 years old with more than 3 month history of pain between 30-60 out of 100 according to visual analoge scale in neck or upper limb with numbness or tingling or weakness in one or two hand whom refered by specialist
Neck disability index 15-25 score out of 50
At least 4/5 degree heag repositioning error in 4 direction
Exclusion criteria:
Positive vertebral artery
Steroidal injection
History of surgery
Upper motor neuron lesion
Medical red flags
People with thorasic outlet syndrom, tennis elbow and carpal tunnel syndrom
Intervention groups
3Groups: Virtual reality training, Conventional proprioception training and control
Main outcome variables
Pain, Disability, Proprioception (position sense)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041897N1
Registration date:2019-04-10, 1398/01/21
Registration timing:prospective
Last update:2019-04-10, 1398/01/21
Update count:0
Registration date
2019-04-10, 1398/01/21
Registrant information
Name
sara shabakhti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 4984
Email address
stud2560308071@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of virtual reality and conventional proprioceptive training in neck region on pain, functional variables and balance in patients with cervical radiculopathy
Public title
Comparison of the effect of computer game and conventional proprioceptive training in neck region on pain, disability and balance in patients with cervical radicular pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40-60 years old
pain history more than 3 month
The average of the highest and lowest pain in the past day was at least 30 to a maximum of 60 out of 100 mm according to Visual Analoge Scale in neck or upper limb with numbness or tingling or weakness in one or two hands
refered by specialist with cervical radiculoathy diagnosis
3 out of 4 tests become positive: spurling test, distraction test, upper limb tension test 1. cervical rotation less than 60 degree
have moderate disability according to neck disability index between 15 to 25 out of 50 score
have at least 4.5 degree head reposistioning error in 4 directions( Flextion, Extension, Rotation to right and left)
Exclusion criteria:
Positive Vertebral Artery test
Steroidal injection in recent two past weeks
history of neck or thorasic surgery
myelopathy
Upper motor neuron lesion sign & symptom for example: stroke ,Multiple sclerosis and amyotrophic lateral sclerosis
medical red flags like: tumor, fracture, Rheumatoid arthritis and Long-term use of steroid medications
People with thorasic outlet syndrome, tennis elbow and carpal tunnel syndrome
Taking effective balance medication over the past 72 hours
Vestibular problems
People who Regularly used analgesic and anti-inflammatory drugs due to neck problem.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
People through Block Randomization and sealed opaque envelopes concealment fall into three groups
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor as well as data analyzer will be blinded to the group allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz School of Rehabilitation Sciences
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
shiraz
Province
Fars
Postal code
33669-71947
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1397.002
Health conditions studied
1
Description of health condition studied
Cervical Radiculopathy
ICD-10 code
M50.1
ICD-10 code description
Cervical disc disorder with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 48 hr after intervention & a month later
Method of measurement
Visual Analoge Scale
2
Description
Disability
Timepoint
Before intervention, 48 hr after intervention & a month later
Method of measurement
Neck Disability Index questionnaire
3
Description
Head Reposition Error
Timepoint
Before intervention, 48 hr after intervention & a month later
Method of measurement
Laser pointer & Graded page
Secondary outcomes
1
Description
Balance
Timepoint
Before intervention, 48 hours after intervention & a month later
Method of measurement
Modified Star Excursion Balance test
2
Description
Kinsiophobia
Timepoint
Before intervention, 48 hours after intervention & a month later
Method of measurement
Tampa Scale of Kinsiophobia questionnaire
3
Description
Neuromuscular control of head and neck movements
Timepoint
Before intervention, 48 hours after intervention & a month later
Method of measurement
Time of movement duty
Intervention groups
1
Description
Control group: This group do the isometric neck exercise, deep neck flexor strengthening exercise, shoulder and scapular strengthening exercise for 10 sessions, three times a week in home. It will check by the physiotherapist once weekly.
Category
Rehabilitation
2
Description
First intervention group: This group do home exercises plus a computar game designed to improve cervicocephalic kinesthesia, eye-head coordination, reflexes related to head and neck, eye and vestibular system with their head and neck movements.The stages of the game are designed easy to difficult sequentially. Ten exercise sessions each lasted 20 minutes is programed. 5 minutes warm up exercises will be performed at the beginning of each session.
Category
Rehabilitation
3
Description
Second intervention group: This group do home exercises plus conventional neck proprioceptive exercises including: The combination of joint position sense and movement sense training (by using laser beam fixed on the head), gaze stability training, eye and head coordination training will be performed in each session and they will be progressed in the next sessions. The duration of each training session and the number of training sessions are the same as first intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Shiraz university of medical sciences
Full name of responsible person
Sara Shabakhti
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 35 3624 0227
Email
sara.shabakhti@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ghasemi Unes
Street address
Floor 7, Center Bilding of Shiraz Univercity of Medical Science, beside Helale Ahmar, Zand street