Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain

NCT04729881 | Unknown DMC

• 1 other identifier: 199400
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Conventional Rehabiliation Group

EXPERIMENTAL

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

Spesific Exercise Group

ACTIVE COMPARATOR

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

Control Group

OTHER

Other: Control group

Interventions

Conventional Rehabiliation Group OTHER

Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise

Conventional Rehabiliation Group

Spesific Exercise Group OTHER

Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise

Spesific Exercise Group

Control group OTHER

No intervention will be aplied

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Medamerikan medical center

Istanbul, Kadıköy, 34724, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Leyla Ataş Balcı, Assist.Prof

  Bahceşehir Unıversıty

  STUDY DIRECTOR

Central Study Contacts

Sevda Yıldız, PT

CONTACT

+905467929046; fzt.sevdayildiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: The individuals are randomly allocated into control, intervention and specific exercise groups.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 29, 2021
• Study Start: February 11, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)