Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain

Effects of Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise on Pain, Functionality, Kinesophobia and Walking Speed in Individuals With Chronic Neck Pain

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.

Study Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Other: Conventional Rehabiliation Group; Other: Spesific Exercise Group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kadıköy
    • Istanbul, Kadıköy, Turkey, 34724
      • Recruiting
      • Medamerikan medical center
      • Contact: İoana Tomi Yılmaz, Physician; Phone Number: 30513 05334250262; Email: itomiyilmaz@medamerikan.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group	Other: Control group; No intervention will be aplied
Experimental: Conventional Rehabiliation Group; 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.	Other: Conventional Rehabiliation Group; Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise
Active Comparator: Spesific Exercise Group; 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.	Other: Spesific Exercise Group; Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change between baseline and 4 weeks
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.	Change between baseline and 4 weeks
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.	Change between baseline and 4 weeks
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.	Change between baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Bahçeşehir University
• Investigators: Study Director: Leyla Ataş Balcı, Assist.Prof, Bahceşehir Unıversıty

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 199400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No