Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mhealth exercise group
brochure exercise group
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, exercise, digital health, mHealth, adherence
Eligibility Criteria
Inclusion Criteria:
- Neck pain that has been going on for at least 3 months
- Participant can use smart phone,
- No problem affecting reading and answering survey questions
Exclusion Criteria:
- Presence of visual and auditory problems that may prevent the use of the smartphone application
- Torticollis
- Vertigo
- Pregnancy
- Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
- Dementia
- Inflammatory rheumatic disease
- Psychosis and neurological disease diagnosis
- Receiving another treatment or having surgery in 3 months
- Exposure to any neck trauma in the past 6 months
- A past or ongoing cancer history
Sites / Locations
- Marmara UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
mhealth exercise group
brochure exercise group
Arm Description
home exercise program is given to patients via mobile application
home exercise program is given to patients via brochure
Outcomes
Primary Outcome Measures
Change from Visual Analog Scale (VAS) score at 6 Weeks
VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.
Change from Exercise Adherence Scale Points at 6 Weeks
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
Secondary Outcome Measures
Change from Neck Pain and Disability Index Points at 6 Weeks
Neck pain and disability balance consist of 20 items. Scoring of each item is done with a 10 cm visual analog scale and scored between 0 and 5 points. The Turkish version study of Biçer et al. Whose reliability and validity has been proven. It was made by (Biçer 2004). The items evaluate the severity of pain and the effect of pain on professional, recreational, social, daily life activities and their relationship with emotional factors. Thus, it measures the effects of neck pain on functionality, quality of life and disability. The total score is the sum of the points in each item and ranges from 0 to 100. The score evaluation was carried out as follows (Buko 2013).
0-4: no problem 5-14: mild severity problem 15-24: moderate severity problem 25-34: severe problem 35 and above: very severe problem
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834895
Brief Title
Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
Official Title
Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:
Increase exercise adherence with mhealth apps.
To reduce pain and disability of patients with chronic neck pain.
Detailed Description
Neck pain is one of the most common musculoskeletal diseases after low back pain in the community. The incidence of neck pain was reported as %37,2. Neck pain can be caused by trauma, poor posture, degenerative diseases, tumors, muscle stress, wiplash injuries, cervical myelopathy, cervical ligamentous instability, fracture, vascular insufficiency or systemic diseases. Neck pain is classified as acute (less than six weeks), subacute (six to twelve weeks) or chronic (lasting more than twelve weeks). While neck pain is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment.
It is emphasized that home exercise programs for neck pain are effective, but exercise adherence is an important factor. Nowadays, with the rapid development of mobile healthcare applications, digital based exercise applications have started to be used in physiotherapy and rehabilitation. Although it has been shown to be useful in studies examining the effectiveness of mHealth applications for different musculoskeletal problems, these studies are quite limited. Several studies have identified the beneficial effects of digital-based exercises, but no clear evidence of superiority over written or oral home exercise programs. In 2019, a mobile exercise application (Neck Exercise) for neck pain patients was developed as a thesis study at Marmara University Health Sciences Institute. The availability of this mobile application is shown on healthy people. However, its efficacy has not been studied in patients with chronic neck pain. This mobile app includes for the neck spinal stabilization , posture, breathing exercises and exercises for scapula circumference. Each exercise is explained with video. In addition, this application gives reminder signals at user-defined time intervals. Participants with chronic neck pain aged between 18-65 years will be included in the study and randomly divided into two groups. One group will be given home exercises via brochure to the other group via mobile application. Participants will be asked to do home exercises 3 days a week for 6 weeks. Pain, disability and exercise adherence of the participants will be evaluated. The Nordic Musculoskeletal Questionnaire, VAS, neck disability index and exercise adherence scale will be used in the evaluation. Our thesis will be the first study examining the effect of a mobile application developed for neck pain on adherence to home exercises. As a result of study, the researchers aim to save paper by prescribing home exercise programs via mobile application and to promote a platform where users can better understand the exercises.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, exercise, digital health, mHealth, adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mhealth exercise group
Arm Type
Active Comparator
Arm Description
home exercise program is given to patients via mobile application
Arm Title
brochure exercise group
Arm Type
Experimental
Arm Description
home exercise program is given to patients via brochure
Intervention Type
Other
Intervention Name(s)
mhealth exercise group
Intervention Description
Participants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
Intervention Type
Other
Intervention Name(s)
brochure exercise group
Intervention Description
Participants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
Primary Outcome Measure Information:
Title
Change from Visual Analog Scale (VAS) score at 6 Weeks
Description
VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.
Time Frame
Baseline and Week 6
Title
Change from Exercise Adherence Scale Points at 6 Weeks
Description
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change from Neck Pain and Disability Index Points at 6 Weeks
Description
Neck pain and disability balance consist of 20 items. Scoring of each item is done with a 10 cm visual analog scale and scored between 0 and 5 points. The Turkish version study of Biçer et al. Whose reliability and validity has been proven. It was made by (Biçer 2004). The items evaluate the severity of pain and the effect of pain on professional, recreational, social, daily life activities and their relationship with emotional factors. Thus, it measures the effects of neck pain on functionality, quality of life and disability. The total score is the sum of the points in each item and ranges from 0 to 100. The score evaluation was carried out as follows (Buko 2013).
0-4: no problem 5-14: mild severity problem 15-24: moderate severity problem 25-34: severe problem 35 and above: very severe problem
Time Frame
Baseline and Week 6
Other Pre-specified Outcome Measures:
Title
Change from The Nordic Musculoskeletal Questionnaire at 6 Weeks
Description
It is used to question musculoskeletal disorders. The Nordic Musculoskeletal Questionnaire, reliable information about the onset, prevalence and outcome of musculoskeletal pain in nine body areas (neck, shoulders, back, elbows, wrists / hands, waist, hips / thighs, knees, ankles / feet) Provider is a questionnaire that can be filled in by self or personal interview technique. The Nordic Musculoskeletal Questionnaire is a measure that can be used for musculoskeletal pain and related conditions in studies conducted in general and / or general communities. The Scandinavian musculoskeletal system query questions yes / no .
Time Frame
Baseline and Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neck pain that has been going on for at least 3 months
Participant can use smart phone,
No problem affecting reading and answering survey questions
Exclusion Criteria:
Presence of visual and auditory problems that may prevent the use of the smartphone application
Torticollis
Vertigo
Pregnancy
Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
Dementia
Inflammatory rheumatic disease
Psychosis and neurological disease diagnosis
Receiving another treatment or having surgery in 3 months
Exposure to any neck trauma in the past 6 months
A past or ongoing cancer history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda TONGA
Phone
90 216 330 20 70
Email
eda.tonga@marmara.edu.tr
Facility Information:
Facility Name
Marmara University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda TONGA
Email
eda.tonga@marmara.edu.tr
12. IPD Sharing Statement
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Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
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