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Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Rehabiliation Group
Spesific Exercise Group
Control group
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scoring over 4 points in the neck disability questionnaire,
  • Having neck pain for at least 3 months,
  • Agreeing to participate in the study voluntarily,
  • 66 individuals between the ages of 18-65 will be included in the study.

Exclusion Criteria:

  • Undergoing surgery in the cervical region,
  • Having a history of acute trauma in the cervical region,
  • Cervical vertebrae infection,
  • Having a history of malignancy,
  • Have inflammatory arthritis,
  • Fracture, dislocation, tumor, infection,
  • Who are pregnant,
  • Receiving physical therapy within the last 1 year,
  • With neurological deficits,
  • Having a cardiac pacemaker,
  • Patients with severe degeneration on magnetic resonance imaging will be excluded from the study.

Sites / Locations

  • Medamerikan medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Conventional Rehabiliation Group

Spesific Exercise Group

Control Group

Arm Description

Participants 5 days a week for 4 weeks; TENS, US and neck specific exercise program will be applied. Conventional TENS will be applied to the participants with the CefarCompex rehab400 (New Chattanooga Compex Rehab, USA) muscle rehabilitation device. It will be applied with electrodes coated with a special adhesive material for each participant for 20 minutes at a frequency of 60-120 Hz. In the study; 4 channels and 8 electrodes will be used. Electrodes will be placed paravertebrally in the cervicothoracic space, covering the painful area. The dose of the current will be increased as the patients become accustomed to the current intensity. Continuous Ultrasound will be applied to the participants due to chronic neck pain. It will be applied at a frequency of 1MHz and a dose of 1.5 W / cm2 for 5 minutes.

Participants will be given a home exercise program consisting of exercises specifically applied to the neck. Participants will be asked to practice the exercises 5 days a week. The application status of the participants' home exercise program will be followed by the researcher over the phone. Participants who do not practice the home exercise program will be excluded from the study. The exercise program to be applied to the participants in the exercise group is listed below.Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
The scale used to determine the severity of pain is 100mm long, and its two ends are named differently on the vertical or horizontal line. The patient will be asked to mark a point on this line corresponding to the intensity of pain he / she feels.The distance between the marked point and the lowest end of the line (0 = no pain) will be measured in millimeters and the numerical value found will be recorded.
Neck Disability Index
The Neck Disability Index scale, developed by Dr. Howard Vernon in 1980, was validated and reliable in 2012 by Kesiktaş et al. The scale evaluating the effects of neck pain on individuals' daily life activities consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study will be asked to score between 0 (no disability) and 5 (complete disability) for each title. The total score ranges from 0 (no disability) to 50 (complete disability). There is no 0-4 limitation in scoring the scale; 5-14: mild disability; 15-24: moderate disability; 25-34: Severe Disability; 35 and above are considered as Totally Disability.
Tampa Kinesiophobia Scale
Developed to measure the fear of motion / re-injury, this scale includes the injury / re-injury and fear-avoidance parameters in work-related activities. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used on the scale consisting of 17 questions. The Turkish validity and reliability of the scale has been proven. The person gets a total score between 17-68. The high score the person gets on the scale indicates that her kinesiophobia is also high.
10 Meter Walk Test
It will be used to evaluate participants' single-task and double-task walking speed (Wa . The only task is to assess walking speed. In the ten-meter walking test, the person will be asked to walk at his / her own normal pace without speaking anything in the previously measured ten-meter field. The time will be started when the person's foot is on the starting line and will be terminated when they cross the finish line. Measurements will be recorded with the stopwatch in meters / second. To assess dual-task walking speeds; individuals will be asked to walk 2 counts from 100 during spontaneous walking of 10 meters and the measurements will be recorded in meters / second with a stopwatch.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
February 11, 2021
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT04729881
Brief Title
Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain
Official Title
Effects of Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise on Pain, Functionality, Kinesophobia and Walking Speed in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
In the treatment of neck pain, physiotherapy modalities such as ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), hot packs and personalized exercise approaches are frequently used. In this planned study, the effects of TENS, ultrasound and a program of stretching, posture and strengthening exercises on pain intensity, functionality, fear of movement and single-task and double-task walking speed in individuals with chronic neck pain will be investigated. Participants will be evaluated initially and after four weeks.66 participants, who will be included in the study with more than 4 points from the neck disability questionnaire, will be randomly divided into 3 groups with 22 people in each group, regardless of the pain severity.Aches; With Visual Analogue Scale (VAS), their functionality; Kinesiophobia with Neck Disability Index; Single-task dual-task walking speeds with the Tampa Kinesiophobia Scale (TSK); It will be evaluated by the 10 Meter Walk Test.
Detailed Description
Among the musculoskeletal complaints of the spine, chronic neck pain (CKP), which is the second most common after low back pain, is seen in the society at a rate of 22-31%, and as it becomes chronic, it leads to an increase in doctor visits. KBA, which often originates from the spine and its surrounding soft tissues, can also be reflected from extravertebral tissues. Common clinical problems that cause neck pain include pathologies such as discopathies of cervical origin, spondylosis, stenosis, myofascial pain syndrome, and mechanical trauma caused by factors such as overuse and improper posture.It is known that being physically inactive in musculoskeletal system pain causes the pain to become chronic. However, CBA may prefer to remain physically inactive due to pain avoidance behaviors in individuals. Kinesiophobia, known as movement aversion; It is defined as "excessive avoidance of movement due to pain, re-injury and sensitivity". In addition to pain and impairment in functionality, CBA can lead to movement avoidance behaviors, many neuromuscular system and biomechanical disorders in individuals.In the studies in the literature, there are no studies that determine the effectiveness of the treatment approaches applied in individuals with CBA on functional status and pain, as well as movement avoidance and double-duty walking, which are effective in daily life. In this context, the aim of the study is to reveal the effectiveness of neck-specific exercises consisting of TENS, US and stretching-posture-strengthening exercises on pain intensity, functionality, kinesophobia and double and single task walking speed in individuals with CBA.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The individuals are randomly allocated into control, intervention and specific exercise groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Rehabiliation Group
Arm Type
Experimental
Arm Description
Participants 5 days a week for 4 weeks; TENS, US and neck specific exercise program will be applied. Conventional TENS will be applied to the participants with the CefarCompex rehab400 (New Chattanooga Compex Rehab, USA) muscle rehabilitation device. It will be applied with electrodes coated with a special adhesive material for each participant for 20 minutes at a frequency of 60-120 Hz. In the study; 4 channels and 8 electrodes will be used. Electrodes will be placed paravertebrally in the cervicothoracic space, covering the painful area. The dose of the current will be increased as the patients become accustomed to the current intensity. Continuous Ultrasound will be applied to the participants due to chronic neck pain. It will be applied at a frequency of 1MHz and a dose of 1.5 W / cm2 for 5 minutes.
Arm Title
Spesific Exercise Group
Arm Type
Active Comparator
Arm Description
Participants will be given a home exercise program consisting of exercises specifically applied to the neck. Participants will be asked to practice the exercises 5 days a week. The application status of the participants' home exercise program will be followed by the researcher over the phone. Participants who do not practice the home exercise program will be excluded from the study. The exercise program to be applied to the participants in the exercise group is listed below.Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise.
Arm Title
Control Group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Conventional Rehabiliation Group
Intervention Description
Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise
Intervention Type
Other
Intervention Name(s)
Spesific Exercise Group
Intervention Description
Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No intervention will be aplied
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
The scale used to determine the severity of pain is 100mm long, and its two ends are named differently on the vertical or horizontal line. The patient will be asked to mark a point on this line corresponding to the intensity of pain he / she feels.The distance between the marked point and the lowest end of the line (0 = no pain) will be measured in millimeters and the numerical value found will be recorded.
Time Frame
Change between baseline and 4 weeks
Title
Neck Disability Index
Description
The Neck Disability Index scale, developed by Dr. Howard Vernon in 1980, was validated and reliable in 2012 by Kesiktaş et al. The scale evaluating the effects of neck pain on individuals' daily life activities consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study will be asked to score between 0 (no disability) and 5 (complete disability) for each title. The total score ranges from 0 (no disability) to 50 (complete disability). There is no 0-4 limitation in scoring the scale; 5-14: mild disability; 15-24: moderate disability; 25-34: Severe Disability; 35 and above are considered as Totally Disability.
Time Frame
Change between baseline and 4 weeks
Title
Tampa Kinesiophobia Scale
Description
Developed to measure the fear of motion / re-injury, this scale includes the injury / re-injury and fear-avoidance parameters in work-related activities. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used on the scale consisting of 17 questions. The Turkish validity and reliability of the scale has been proven. The person gets a total score between 17-68. The high score the person gets on the scale indicates that her kinesiophobia is also high.
Time Frame
Change between baseline and 4 weeks
Title
10 Meter Walk Test
Description
It will be used to evaluate participants' single-task and double-task walking speed (Wa . The only task is to assess walking speed. In the ten-meter walking test, the person will be asked to walk at his / her own normal pace without speaking anything in the previously measured ten-meter field. The time will be started when the person's foot is on the starting line and will be terminated when they cross the finish line. Measurements will be recorded with the stopwatch in meters / second. To assess dual-task walking speeds; individuals will be asked to walk 2 counts from 100 during spontaneous walking of 10 meters and the measurements will be recorded in meters / second with a stopwatch.
Time Frame
Change between baseline and 4 weeks

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: Scoring over 4 points in the neck disability questionnaire, Having neck pain for at least 3 months, Agreeing to participate in the study voluntarily, 66 individuals between the ages of 18-65 will be included in the study. Exclusion Criteria: Undergoing surgery in the cervical region, Having a history of acute trauma in the cervical region, Cervical vertebrae infection, Having a history of malignancy, Have inflammatory arthritis, Fracture, dislocation, tumor, infection, Who are pregnant, Receiving physical therapy within the last 1 year, With neurological deficits, Having a cardiac pacemaker, Patients with severe degeneration on magnetic resonance imaging will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevda Yıldız, PT
Phone
+905467929046
Email
fzt.sevdayildiz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla Ataş Balcı, Assist.Prof
Organizational Affiliation
Bahceşehir Unıversıty
Official's Role
Study Director
Facility Information:
Facility Name
Medamerikan medical center
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34724
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İoana Tomi Yılmaz, Physician
Phone
05334250262
Ext
30513
Email
itomiyilmaz@medamerikan.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain

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