NCT06320938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

April 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

March 13, 2024

Last Update Submit

August 31, 2025

Conditions

Keywords

Pain neuroscience educationMyofascial induction techniqueMyofascial treatmentHome exercisesPainNeck Disability

Outcome Measures

Primary Outcomes (8)

  • 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

  • Algometric Digital Measurement

    It is a digital device used to evaluate trigger point sensitivity.

    Baseline,8 weeks, 6 months

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Neuroscience-Based Pain Education Combined with Home Exercise Program

ACTIVE COMPARATOR

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

Myofascial Induction Techniques Combined with Home Exercise Program

ACTIVE COMPARATOR

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

Home Exercise Program

ACTIVE COMPARATOR

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

Interventions

Neuroscience-Based Pain Education and Home Exercises will be applied.

Neuroscience-Based Pain Education Combined with Home Exercise Program

Myofascial Induction Techniques and Home Exercises will be applied.

Myofascial Induction Techniques Combined with Home Exercise Program

Home Exercises wiil be applied

Home Exercise Program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Türkoğlu Dr. Kemal Beyazıt State Hospital

Kahramanmaraş, Turkey (Türkiye)

Location

Related 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.

    PMID: 33466426BACKGROUND
  • 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.

    PMID: 34062143BACKGROUND
  • 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.

    PMID: 34444594BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aysenur Tuncer, Assoc. Prof.

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

April 18, 2024

Primary Completion

January 15, 2025

Study Completion

May 25, 2025

Last Updated

September 3, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations