Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain

March 25, 2024 updated by: Süreyya DAMAR ÖRENLER, Turkoglu Dr. Kemal Beyazit State Hospital

Comparison of the Effects of Neuroscience-Based Pain Education and Myofascial Induction Technique on Pain and Quality of Life in Patients With Chronic Neck Pain

The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to present the immediate and long-term effects of Neuroscience-based Pain Education (NPE) and Myofascial Induction Therapy (MIT). It will evaluate parameters such as pain, quality of life, pain catastrophizing, and neck disability after treatment completion and at the 6-month follow-up.

The investigators aim to illuminate future studies concerning neuroscience-based pain education, which has gained prominence in recent years and continues to increase in importance annually.

The participants will be randomly assigned to one of three groups:

1 Group: Neuroscience-Based Pain Education Combined with Home Exercise Program Participants in this group will receive Neuroscience-Based Pain Education (NPE) treatment in addition to the home exercise program. Training sessions will be organized as one-on-one conversation sessions focusing on the neurophysiology of pain, and participants will be reinforced through PowerPoint presentations and visual aids such as pictures, templates, and metaphors.

Group: Myofascial Induction Techniques Combined with Home Exercise Program In addition to the home exercise program, Myofascial Induction Techniques (MIT) group participants will have MIT applied to the cervical and upper thoracic regions.

Group: Home Exercise Program After undergoing general training, participants in this group will be taught an exercise program. The program will include neck muscle stretching, strengthening, and posture exercises.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey
        • Türkoğlu Dr. Kemal Beyazıt State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages between 18-60 years old,
  2. Patients with non-specific neck pain for at least 3 months,
  3. Having pain severity of four or more according to the Visual analogue scale (VAS),
  4. Patients with Pain Catastrophizing Scale score > 30
  5. Patients with a Central Sensitization Inventory score > 30
  6. Not having received physiotherapy and manual therapy within the last 3 months,
  7. Those who have not received and will not receive medical treatment in the last 3 months.

Exclusion Criteria:

  1. Having a history of neck and spine surgery,
  2. Patients with whiplash injury, fracture history,
  3. Having unstable neurological findings,
  4. Presence of a pathology such as hernia and root compression in the cervical region,
  5. Those who regularly use analgesic and anti-inflammatory drugs,
  6. A communication problem may prevent the implementation of the evaluations or treatment program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuroscience-Based Pain Education Combined with Home Exercise Program
Patients in this group will receive Neuroscience-Based Pain Education (NPE) treatment in addition to the home exercise program. Training sessions are planned once a week for an average of 35-45 minutes and 8 sessions. NPE will be performed by a physiotherapist who has an internationally recognized certificate in this regard. Training sessions will be organized as one-on-one conversation sessions focusing on the neurophysiology of pain, and patients will be reinforced through PowerPoint presentations and visual pictures, templates, and metaphors.
Other: Neuroscience-Based Pain Education Combined with Home Exercise Program
Neuroscience-Based Pain Education and Home Exercises will be applied.
Active Comparator: Myofascial Induction Techniques Combined with Home Exercise Program
In addition to the home exercise program, Myofascial Induction Techniques (MIT) group patients will have MIT applied to the cervical and upper thoracic regions by a physiotherapist trained and experienced in myofascial treatments. The application will be once a week for 8 weeks, with an average duration of 35-45 minutes.
Other: Myofascial Induction Techniques Combined with Home Exercise Program
Myofascial Induction Techniques and Home Exercises will be applied.
Active Comparator: Home Exercise Program
Patients in this group will be taught an exercise program after undergoing general training. Exercises will include stretching and strengthening exercises for neck muscles and posture exercises. Patients are asked to take 35-45 minutes once a day, five days a week, for 8 weeks. They will be asked to do the given home exercises and fill out follow-up charts. The continuity of the exercises will be ensured by sending reminder messages to this group of patients once a week by the physiotherapist about doing their exercises.
Other: Home Exercises Group
Home Exercises wiil be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algometric Digital Measurement
Time Frame: Baseline,8 weeks, 6 months
It is a digital device used to evaluate trigger point sensitivity.
Baseline,8 weeks, 6 months
Central Sensitization Inventory
Time Frame: Baseline,8 weeks, 6 months
The scale, which can be applied in chronic pain, is used in central sensitization syndromes. It consists of two parts. Section A questions health-related symptoms, and part B questions whether any central sensitization syndromes have been diagnosed before.
Baseline,8 weeks, 6 months
Head Posture Evaluation
Time Frame: Baseline,8 weeks, 6 months
Forward head posture is measured with a goniometer, which measures the angle between the horizontal plane and the seventh cervical vertebra and ear line.
Baseline,8 weeks, 6 months
Neck Disability Index
Time Frame: Baseline,8 weeks, 6 months
The scale consists of ten headings in total. It includes neck pain intensity, personal care, lifting, reading, headaches, concentration, driving, sleep, and leisure activities.
Baseline,8 weeks, 6 months
Pittsburgh Sleep Quality Index
Time Frame: Baseline,8 weeks, 6 months
This survey contains 24 questions about sleep status, both during the day and at night. Nineteen of these are to be answered personally, and five are to be answered by a spouse or roommate.
Baseline,8 weeks, 6 months
Short Form McGill Pain Questionnaire
Time Frame: Baseline,8 weeks, 6 months
A short form of the McGill Pain Questionnaire (SF-MPQ) used in pain assessment consists of four sections. In the first section, participants are asked to mark the location of pain on a body diagram. In the second section, participants are asked to select the word that best describes their pain from twenty subgroups. The third section investigates the relationship of pain over time, while the fourth and final section requires participants to indicate the intensity of pain on a scale of 1 to 5 and provide written responses to six questions. The questionnaire is scored from 0 to 112. The higher the pain score, the greater the pain.
Baseline,8 weeks, 6 months
36-Item Short Form Health Survey Questionnaire
Time Frame: Baseline,8 weeks, 6 months
36-Item Short Form Health Survey (SF-36) questionnaire consists of eight subscales: physical functioning, social functioning, role limitations due to physical problems, pain, vitality, mental health, and general health perception. Each subscale is scored from 0 to 100, and the scores from these subscales are not summed. A high score indicates good health status.
Baseline,8 weeks, 6 months
Pain Catastrophizing Scale
Time Frame: Baseline,8 weeks, 6 months
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure of catastrophizing in the context of actual or anticipated pain. The PCS measures catastrophizing as a multidimensional construct with three subscales: rumination, magnification, and helplessness. Rumination focuses on thoughts related to pain, helplessness reflects feelings of helplessness in coping with a painful situation, and magnification is a general view of the threat of pain. High PCS scores are associated with greater pain and more functional impairment. A total score above 30 represents clinically significant levels of pain catastrophizing.
Baseline,8 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkoglu Dr. Kemal Beyazit State Hospital

Investigators

  • Study Director: Aysenur Tuncer, Assoc. Prof., Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 18, 2024

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/18

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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