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The effects of an exergame on the pain and muscle strength in people with neck osteoarthritis

Protocol summary

Study aim
The aim of this pilot study was to design an exergame and clinical evaluation of its effect on pain sensation and muscle strength in people with cervical osteoarthritis
Design
This was a parallel-group clinical study. Subjects were randomly divided into two groups by drawing a concealed envelop from a bag.
Settings and conduct
This study was a parallel-groups clinical trial. Participants were allocated into two groups using a stratified randomization method (the severity of the lesion was the stratification factor). Participants were recruited through a convenience sampling method and from outpatient clinic of the Shariati Hospital, Isfahan, Iran. There was no blinding for participants and assessor.
Participants/Inclusion and exclusion criteria
Patients with a history of clinical symptoms such as mild and moderate spondylosis, neck pain (at least score 3 for pain intensity based on the visual analog scale, muscle spasm in the neck or shoulder and the numbness in the hands were included in this study. Individuals with severe neck spondylosis, spinal stenosis, history of neck fracture or spine surgery, cervical osteoarthritis(grade 4), spinal canal stenosis, history of spinal fracture or surgery, severe osteoporosis, neurological disease, cardiovascular dysfunction, pregnancy, and spinal deformities were excluded .
Intervention groups
Intervention group received the conventional physiotherapy modalities that were delivered with isometric exercise through the computerized game (exergame). Control group received The conventional physiotherapy protocols for neck pain followed with hand-resisted isometric exercise.
Main outcome variables
Neck function, pain intensity, and isometric strength of neck muscles were measured before and after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150210021034N6
Registration date: 2020-02-06, 1398/11/17
Registration timing: retrospective

Last update: 2020-02-06, 1398/11/17
Update count: 0
Registration date
2020-02-06, 1398/11/17
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
2018-12-22, 1397/10/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
2019-05-10, 1398/02/20
Actual recruitment end date
2019-07-21, 1398/04/30
Trial completion date
2019-07-21, 1398/04/30
Scientific title
The effects of an exergame on the pain and muscle strength in people with neck osteoarthritis
Public title
Effects of therapeutic game for neck pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with clinical symptoms of mild and moderate neck osteoarthritis Neck pain (if pain is scored at least 3 on visual analouge scale) Muscle spasm Sensory loss in the arm Shoulder or scapular muscles pain
Exclusion criteria:
People with severe neck osteoarthritis Canal stenosis A history of vertebral fracture Severe osteoporosis Rheumatoid arthritis Neurological disease Cardiovascular disease Pregnancy Spinal deformities
Age
From 27 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was stratified by severity of the lesion (mild/moderate) to pursue equal distribution of the degrees of severity for both intervention and control groups. Randomization in each stratum was carried out by having a piece of paper that has the phrase "intervention (exergame+physiotherapy)" and "control (hand exercise+physiotherapy)" placed inside an envelope. The outside of the envelops were sequentially numbered. After participants have been enrolled in the study and consented, a sequence number envelope on the stack will be randomly drawn and opened to determine the study group that the participant will enter.
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 University of Esfahan
Street address
Daneshgah Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2019-11-06, 1398/08/15
Ethics committee reference number
IR.UI.REC.1398.047

Health conditions studied

1

Description of health condition studied
People with grade 2 (mild) and grade 3 (moderate) cervical spondylosis
ICD-10 code
M43.02
ICD-10 code description
Spondylolysis, cervical region

Primary outcomes

1

Description
Neck function
Timepoint
The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions.
Method of measurement
Neck was assessed using the "Neck disability index".

2

Description
Pain intensity
Timepoint
The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions.
Method of measurement
Pain intensity was measured using "visual analogue scale".

3

Description
Isometric strength of neck muscles
Timepoint
The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions.
Method of measurement
The isometric strength of neck muscles were measured using a digital force dynamometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The conventional physiotherapy modalities were delivered with isometric exercise through the computerized game (exergame). The conventional physiotherapy included heating through a towel at 74 degrees of Celsius, transcutaneous electrical stimulation (pulse duration:100-110 ms; frequency: 70-80 Hz), ultrasound modality (pulse wave with intensity of 1.25-1.5 W/cm2; duration: 5 min), and stretching of the upper trapezius muscle (10-30 seconds; 3-5 repeats). The exergame included software and a glove as a controller of the game. The isometric neck exercises are carried out while the patient was playing the game. The hand pressure against the head was applied in four directions. This pressure was holding 10 seconds to control the motion of the game character in the game's path.
Category
Rehabilitation

2

Description
Control group: The conventional physiotherapy protocols for neck pain followed with hand-resisted isometric exercise. The conventional physiotherapy was the same as explained for the exergame group. The participants were instructed to apply pressure by their hand against the head and hold it for 10 s in four directions. Each pressure repeated five times, and two minutes rest was given after each exercise set. People carried out the exercise three times a day and repeated it every other day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mehdi Naghosi
Street address
Charbagh Bala St.
City
Isfahan
Province
Isfehan
Postal code
1411713135
Phone
+98 31 3627 2001
Fax
+98 31 3624 3028
Email
shariati_isf.hos@tamin.ir
Web page address
https://www.tamin.ir/news/service/172

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Houshang Talebi
Street address
Daneshgah St.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Fax
+98 31 3668 7396
Email
info@ui.ac.ir
Web page address
http://ui2.ui.ac.ir/
Grant name
Postgraduate studies
Grant code / Reference number
1398.047
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
0098 31 7925235
Fax
+98 31 3668 7220
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://rehab.mui.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 914 044 8890
Fax
+98 31 3668 7220
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://rehab.mui.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demneh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5235
Fax
+98 31 3668 7270
Email
sadeghi@rehab.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study data (excluding the personal details) can be shred with other researchers or systematic reviewers.
When the data will become available and for how long
No limit was set.
To whom data/document is available
No specific limitation is considered.
Under which criteria data/document could be used
No terms and conditions is considered for sharing the data.
From where data/document is obtainable
People can sent their request to the correspondence and obtain the data.
What processes are involved for a request to access data/document
Request can be sent through an email.
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