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The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Program Applied by Telerehabilitation
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • voluntary individuals suffering from neck pain for at least 3 months
  • over the age of 18
  • have a minimum score of 3/10 according to the Numeric Pain Rating Scale
  • who fill out the pain preliminary information form, and who will agree to participate in the study through this form.

Exclusion Criteria:

  • Pregnant women,
  • History of malignancy
  • Congenital deformities or surgery history in the neck or shoulder area
  • perception problems for verbal commands
  • not having internet access
  • not having equipment to make video calls

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Supervised Exercise Group

Exercise Group

Control Group

Arm Description

Telerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes Exercises that will be performed every Monday will be taught and applied face-to-face under the supervision of the therapist with online videoconferencing method. Then, videos of weekly exercises that will be prepared by the therapist will be transmitted online to patients. Patients will be asked to perform these exercises 4 days a week in the same week, on Wednesdays, Fridays and Sundays. Also, a video call will be made on Fridays to evaluate whether the movements are done effectively and correctly, and questions of patients (if any) will be answered. Patients will be informed by the physiotherapist that they should send messages on Wednesdays and Sundays to show that they are doing the exercises. The exercise program of new week will be taught every Monday for 4 weeks, the prepared video will be sent, and the program will be advanced and completed.

Exercise recommendations will be made to this group. Videos and photographs of weekly exercises prepared by the therapist will be sent online to the patient every Monday for 4 weeks, patients will be advised to repeat these exercises 4 days a week.

No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Numeric Pain Rating Scale (NPRS) will be used to evaluate pain subjectively. NPRS is used to evaluate pain. The patient is asked to rate the severity of pain over 10, 0 showing no pain, and 10 showing the worst pain score. Validity and validation of the use of NPRS to evaluate chronic pain in the literature with face-to-face and telepresentation methods. Its reliability has been reported
Deep Neck Flexor Endurance Test
Patients are asked to lie on a flat ground in the form of a "hook" during the online video conference. They are then asked to move their jaws closer to their chests in the Chin Tuck Position, raise their heads approximately 2.5 cm, and remain in this position. If patients experience any pain and fatigue or put their heads back on the floor, the test is terminated. The physiotherapist keeps track of the patient during this period. Two measurements are made, and the long-lasting result is recorded. The validity and reliability of the evaluation has been demonstrated by the online video videoconferencing method.

Secondary Outcome Measures

Neck Disability Index (NDI)
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The NDI consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each question has 6 answer options measuring the severity of pain or limitation. Scoring is done between 0 and 5. The highest score is 50, and the minimum score in 0. According to the total score; 0-4 means no limitation, 5-14 means slight limitation, 15-24 moderate limitation, 25-34 severe limitation, 34 and above completely limitation . The Turkish validity and reliability study of the survey was conducted.
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
There are two versions of this scale as the long (WHOQOLS-100) and short (WHOQOLS-27) form. The scale measures the bodily, spiritual, social, and environmental well-being of the individual, and consists of 26 questions. The Turkish version consists of 27 questions. The 27th question is the national question determining the Environmental Area Score. The scale can be applied to non-elderly adults . The field scores are calculated between 4 and 20 because each field refers to the quality of life in the relevant field independently from each other. As the score increases, the quality of life increases. The Turkish validity and reliability study of the scale was conducted .

Full Information

First Posted
March 31, 2021
Last Updated
April 1, 2021
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04831931
Brief Title
The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain
Official Title
The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Neck pain is a common musculoskeletal problem occurring as one of the first conditions causing decreased quality of life and disability. An estimated 67.5% of people experience neck pain in their lives (5, 6). When the adult population is considered (15-74 years old), the prevalence ranges from 5.9% to 38.7%. Causes of neck pain are largely variable, and include working in unsuitable ergonomic positions, sitting for a long time, and keeping the neck in abnormal physiological position for a long time. Various factors are effective in the chronic stage of neck pain. Neck pain is associated with decreased strength and endurance of the cervical muscles. It was observed that deep flexor muscles are weak and superficial flexor muscle activity is increased in patients with neck pain; and that exercise is effective in reducing neck pain because strength, endurance, and flexibility can be regained in the structures around the damaged tissue. There are several approaches that were found to be effective in the treatment of neck pain. These treatment strategies include physical therapy modalities, manual therapy, therapeutic exercise (stretching, strengthening, and endurance exercises) and home exercise programs. Home exercise programs are used to expand the clinic-based physical therapy approaches to treat neck pain. It was stated that it is now compulsory to develop new rehabilitation models and practices to cope with global increase in elderly population, limited resources allocated to public health, and changes in population needs. Telerehabilitation is recommended as a solution to provide physical therapy services; however, it was reported in previous studies that more studies are required in this field to accept its effectiveness. The purpose of the present study is to examine the effects of 4-week exercise protocol established with stretching, strengthening the scapula muscles for the neck and upper body, neck and core stabilization exercises by ensuring the follow-up of the patients with Telerehabilitation Method on patients' neck pain, Daily Life Activities (DLA), and quality of life by comparing its effects with individuals who apply only home program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Group
Arm Type
Experimental
Arm Description
Telerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes Exercises that will be performed every Monday will be taught and applied face-to-face under the supervision of the therapist with online videoconferencing method. Then, videos of weekly exercises that will be prepared by the therapist will be transmitted online to patients. Patients will be asked to perform these exercises 4 days a week in the same week, on Wednesdays, Fridays and Sundays. Also, a video call will be made on Fridays to evaluate whether the movements are done effectively and correctly, and questions of patients (if any) will be answered. Patients will be informed by the physiotherapist that they should send messages on Wednesdays and Sundays to show that they are doing the exercises. The exercise program of new week will be taught every Monday for 4 weeks, the prepared video will be sent, and the program will be advanced and completed.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise recommendations will be made to this group. Videos and photographs of weekly exercises prepared by the therapist will be sent online to the patient every Monday for 4 weeks, patients will be advised to repeat these exercises 4 days a week.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online.
Intervention Type
Other
Intervention Name(s)
Exercise Program Applied by Telerehabilitation
Intervention Description
Patients will be evaluated 3 times for 4 weeks throughout the study; before the study commences, at the end of 2th and 4th week Exercises will be planned to last for 15 minutes a day, and will be progressed and changed weekly throughout the study period. To the exercise program; It will be created as a progressive program by including stretching, normal range of motion movements, neck, core and scapular stabilization and strengthening exercises and the same program will be given to both groups.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale (NPRS) will be used to evaluate pain subjectively. NPRS is used to evaluate pain. The patient is asked to rate the severity of pain over 10, 0 showing no pain, and 10 showing the worst pain score. Validity and validation of the use of NPRS to evaluate chronic pain in the literature with face-to-face and telepresentation methods. Its reliability has been reported
Time Frame
4 weeks
Title
Deep Neck Flexor Endurance Test
Description
Patients are asked to lie on a flat ground in the form of a "hook" during the online video conference. They are then asked to move their jaws closer to their chests in the Chin Tuck Position, raise their heads approximately 2.5 cm, and remain in this position. If patients experience any pain and fatigue or put their heads back on the floor, the test is terminated. The physiotherapist keeps track of the patient during this period. Two measurements are made, and the long-lasting result is recorded. The validity and reliability of the evaluation has been demonstrated by the online video videoconferencing method.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The NDI consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each question has 6 answer options measuring the severity of pain or limitation. Scoring is done between 0 and 5. The highest score is 50, and the minimum score in 0. According to the total score; 0-4 means no limitation, 5-14 means slight limitation, 15-24 moderate limitation, 25-34 severe limitation, 34 and above completely limitation . The Turkish validity and reliability study of the survey was conducted.
Time Frame
4 weeks
Title
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Description
There are two versions of this scale as the long (WHOQOLS-100) and short (WHOQOLS-27) form. The scale measures the bodily, spiritual, social, and environmental well-being of the individual, and consists of 26 questions. The Turkish version consists of 27 questions. The 27th question is the national question determining the Environmental Area Score. The scale can be applied to non-elderly adults . The field scores are calculated between 4 and 20 because each field refers to the quality of life in the relevant field independently from each other. As the score increases, the quality of life increases. The Turkish validity and reliability study of the scale was conducted .
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: voluntary individuals suffering from neck pain for at least 3 months over the age of 18 have a minimum score of 3/10 according to the Numeric Pain Rating Scale who fill out the pain preliminary information form, and who will agree to participate in the study through this form. Exclusion Criteria: Pregnant women, History of malignancy Congenital deformities or surgery history in the neck or shoulder area perception problems for verbal commands not having internet access not having equipment to make video calls
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain

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