Clinical trial NCT06320938: Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spine Disease
Keywords: Pain neuroscience education
Myofascial induction technique
Myofascial treatment
Home exercises
Pain
Neck Disability
Lead sponsor: Turkoglu Dr. Kemal Beyazit State Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short Form McGill Pain Questionnaire
timeFrame: Baseline,8 weeks, 6 months
measure: Algometric Digital Measurement
timeFrame: Baseline,8 weeks, 6 months
measure: Central Sensitization Inventory
timeFrame: Baseline,8 weeks, 6 months
measure: Head Posture Evaluation
timeFrame: Baseline,8 weeks, 6 months
measure: Neck Disability Index
timeFrame: Baseline,8 weeks, 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline,8 weeks, 6 months
measure: 36-Item Short Form Health Survey Questionnaire
timeFrame: Baseline,8 weeks, 6 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline,8 weeks, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Türkoğlu Dr. Kemal Beyazıt State Hospital
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.