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Applied in Patients With Neck Pain Added to the Conventional Physiotherapy Program Effectiveness of Pain Education

Primary Purpose

Neck Pain, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional physiotherapy
Neuroscience education
Sponsored by
Istanbul Arel 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:

  • between the ages of 18-65
  • neck pain that persists for 3 months or more

Exclusion Criteria:

  • Patients undergoing cervical surgery
  • Patients with neck pain secondary to neurological or vascular disease or neoplasia
  • Patients with radiculopathy with neurological deficits
  • Patients with a history of inflammatory or infective arthritis of the cervical spine
  • Patients who received a physical therapy program in the last 6 months
  • Patients with pain in the scapula, shoulder, upper extremity or lumbar region that may interfere with neck stabilization exercises

Sites / Locations

  • Özden YAŞARERRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Conventional physiotherapy

Neuroscience education

Arm Description

Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.

Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.

Outcomes

Primary Outcome Measures

Pain Intensity
Self reported pain intensity .. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale'. Each item scored is 0-10 (0=no pain 10=pain as bad as can be)
Range Of Motion
The CROM (Cervical Range-of-Motion Instrument) combines AMA-required inclinometers and magnets in an easy-to-use instrument. It eliminates positioning, zeroing and tracking errors that are common with stand-alone inclinometers. Standardized protocol minimizes the chance of examination error.
Kinesiofobia
Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.
Disability
Self reported. The level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' . Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together.
Quality of life level
Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.
Pain pressure threshold
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Pain knowledge
Self reported. The Neurophysiology of Pain Questionnaire (NPQ) was devised to assess how an individual conceptualizes the biological mechanisms that underpin his or her pain. presents 12 items, and the answer options also consist of "true, false or undecided". Its psychometric properties constitute a one- -dimensional scale with good test-retest reliability. The results are interpreted as follows: each hit corresponds to one point, if the individual makes a mistake or choose the "undecided" alternati- ve, the item is reset to zero; therefore, the score ranges from zero to 12, and the higher the score, the greater the level of unders- tanding of the mechanisms present in pain

Secondary Outcome Measures

Full Information

First Posted
December 7, 2021
Last Updated
October 31, 2022
Sponsor
Istanbul Arel University
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1. Study Identification

Unique Protocol Identification Number
NCT05210257
Brief Title
Applied in Patients With Neck Pain Added to the Conventional Physiotherapy Program Effectiveness of Pain Education
Official Title
Applied in Patients With Neck Pain Added to the Conventional Physiotherapy Program Effectiveness of Pain Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel 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
Purpose: The aim of this study is to examine the effects of pain training applied with conventional physiotherapy on pain, range of motion, disability, kinesiophobia and quality of life in patients with neck pain. Methods: The research is planned to be completed within 18 months at Istanbul Hospital. It is planned to include 40 individualsbetween the ages of 18-65 with neck pain persisting for 3 months or more.Individuals will be randomly divided into 2 groups. Conventional physiotherapy program will be applied to the first group. Conventional physiotherapy will be applied to the second group and neuroscience education will be given.Pain intensity will evaluate before and after exercise with 'Visual Analog Scale' (VAS), and algometer,range of motion will evaluate with C-ROM, kinesiofobia will questioned with Tampa Kinesiofobia Score, Quality of life will evaluate with Nottingham Health Profile, whereas the level of neck disability will evaluate before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results will analyze using appropriate statistical methods.
Detailed Description
The treatment program will be applied 3 days a week for 8 weeks.Each 2 groups; will be evaluated twice, at the beginning of the treatment and at the end of the 8th week. Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents. Neuroscience education; The trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions. Posters, pictures, graphics and stories, as well as booklets and videos from Explain Pain, Pain in motion and retrainpain websites will be used in appropriate sessions.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physiotherapy
Arm Type
Other
Arm Description
Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.
Arm Title
Neuroscience education
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Group 1 was given conventinal physiotherapy Physiotherapy agents; 5 min ultrasound 1.5 watts/cm2 20 min conventional TENS 20 min heat agent application (hot pack) Exercise program; Stretching and relaxation exercises, Neck strengthening exercises that include concentric and isometric contractions Posture exercises 3 sets per day, 1 in the hospital with 10 repetitions
Intervention Type
Other
Intervention Name(s)
Neuroscience education
Intervention Description
Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions. In sessions ; neurons and nerve conduction in the session, the formation process of pain, peripheral neuropathic pain, pain spread during the session, neuroplasticity, peripheral and central sensitization, hyperalgesia and allodynia, acute-chronic pain, The effects of stress, fear, anxiety, false thoughts and beliefs about pain and other psychosocial factors on the pain process and determining possible psychosocial factors in the patient during the session, Strategies for controlling the pain process and coping with psychosocial factors in the session will be completed by explaining the effect mechanisms of exercise on pain.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Self reported pain intensity .. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale'. Each item scored is 0-10 (0=no pain 10=pain as bad as can be)
Time Frame
8 weeks
Title
Range Of Motion
Description
The CROM (Cervical Range-of-Motion Instrument) combines AMA-required inclinometers and magnets in an easy-to-use instrument. It eliminates positioning, zeroing and tracking errors that are common with stand-alone inclinometers. Standardized protocol minimizes the chance of examination error.
Time Frame
8 weeks
Title
Kinesiofobia
Description
Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.
Time Frame
8 weeks
Title
Disability
Description
Self reported. The level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' . Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together.
Time Frame
8 weeks
Title
Quality of life level
Description
Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.
Time Frame
8 weeks
Title
Pain pressure threshold
Description
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Time Frame
8 weeks
Title
Pain knowledge
Description
Self reported. The Neurophysiology of Pain Questionnaire (NPQ) was devised to assess how an individual conceptualizes the biological mechanisms that underpin his or her pain. presents 12 items, and the answer options also consist of "true, false or undecided". Its psychometric properties constitute a one- -dimensional scale with good test-retest reliability. The results are interpreted as follows: each hit corresponds to one point, if the individual makes a mistake or choose the "undecided" alternati- ve, the item is reset to zero; therefore, the score ranges from zero to 12, and the higher the score, the greater the level of unders- tanding of the mechanisms present in pain
Time Frame
8 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: between the ages of 18-65 neck pain that persists for 3 months or more Exclusion Criteria: Patients undergoing cervical surgery Patients with neck pain secondary to neurological or vascular disease or neoplasia Patients with radiculopathy with neurological deficits Patients with a history of inflammatory or infective arthritis of the cervical spine Patients who received a physical therapy program in the last 6 months Patients with pain in the scapula, shoulder, upper extremity or lumbar region that may interfere with neck stabilization exercises
Facility Information:
Facility Name
Özden YAŞARER
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özden YAŞARER
Phone
5343845684
Email
ozdenyasarer@gmail.com
First Name & Middle Initial & Last Name & Degree
Özden YAŞARER

12. IPD Sharing Statement

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Applied in Patients With Neck Pain Added to the Conventional Physiotherapy Program Effectiveness of Pain Education

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