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

Cervical Spine Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320938
• Other study ID #: 2024/18
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: Turkoglu Dr. Kemal Beyazit State Hospital
• Contact: Süreyya DAMAR ÖRENLER, PhD
• Phone: 05433967170
• Email: fztsureyya88[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spine Disease
• Neck Pain
• Spinal Diseases

Intervention

Other:
• Neuroscience-Based Pain Education Combined with Home Exercise Program
Neuroscience-Based Pain Education and Home Exercises will be applied.
• Myofascial Induction Techniques Combined with Home Exercise Program
Myofascial Induction Techniques and Home Exercises will be applied.
• Home Exercises Group
Home Exercises wiil be applied

Locations

Country	Name	City	State
Turkey	Türkoglu Dr. Kemal Beyazit State Hospital	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Turkoglu Dr. Kemal Beyazit State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bernetti A, Agostini F, de Sire A, Mangone M, Tognolo L, Di Cesare A, Ruiu P, Paolucci T, Invernizzi M, Paoloni M. Neuropathic Pain and Rehabilitation: A Systematic Review of International Guidelines. Diagnostics (Basel). 2021 Jan 5;11(1):74. doi: 10.3390/diagnostics11010074. — View Citation

Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7. — View Citation

Javdaneh N, Saeterbakken AH, Shams A, Barati AH. Pain Neuroscience Education Combined with Therapeutic Exercises Provides Added Benefit in the Treatment of Chronic Neck Pain. Int J Environ Res Public Health. 2021 Aug 22;18(16):8848. doi: 10.3390/ijerph18168848. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form McGill Pain Questionnaire	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
Primary	Algometric Digital Measurement	It is a digital device used to evaluate trigger point sensitivity.	Baseline,8 weeks, 6 months
Primary	Central Sensitization Inventory	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
Primary	Head Posture Evaluation	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
Primary	Neck Disability Index	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
Primary	Pittsburgh Sleep Quality Index	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
Primary	36-Item Short Form Health Survey Questionnaire	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
Primary	Pain Catastrophizing Scale	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