Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial

PURPOSE: The purpose of the present study is to investigate the benefit of applying dermoneuromodulation techniques in patients with non-specific chronic neck pain.

BACKGROUND: Chronic neck pain is one of the most commonly reported musculoskeletal pathologies in the general population. It has an immense impact on the physical, social, and psychological aspects and quality of life of the individual and society as a whole. Dermoneuromodulation(DNM) is recently popularising touch based pain relieving approach which is a gentle, structured method of interacting with patient's nervous system to help them resolve pain, regain function, and feel better. It was developed by Diane Jacobs, a Canadian physiotherapist specialised in pain science and the treatment of painful conditions. During her 40 years of practice, Jacobs was interested in Ronald Melzack, who developed the original Gate Control theory of pain along with Patrick Wall, and who later developed the NeuroMatrix model of pain. In 2007, Jacobs made a cadaver study that defined how peripheral cutaneous nerves divide into rami, which spread outward into the underside of skin. This work inspired her to develop a new conceptual approach to manual therapy for patients with pain.

HYPOTHESES We hypothesize that there will be no effect of dermoneuromodulation techniques on clinical outcomes of patients with non-specific chronic neck pain.

RESEARCH QUESTION: Is there a statistically significant effect of dermoneuromodulation techniques on clinical outcomes of patients with non-specific chronic neck pain?

Study Overview

• Status: Recruiting
• Conditions: Cervical Pain; Cervical
• Intervention / Treatment: Other: Supervised Exercise Program; Other: Supervised Exercise Program plus Dermoneuromodulation Techniques

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg
• Study Contact Backup: Name: Amal M Fawzy, Ph.d; Email: dr.amalfawzy@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recurrent history of non-specific chronic neck pain (NSCNP) of not less than 3 months duration.
• Pain level greater than or equal to 5/10 on the Numeric Pain Rating Scale (NPRS).
• Age between 25 to 40 years.
• Both male and female participants.
• Diagnosis of non-specific chronic neck pain confirmed by a licensed physiotherapist or physician using a combination of the following criteria:
• Absence of specific pathologies or conditions causing neck pain (e.g., disc prolapse, tumor of the cervical spine, whiplash injury, cervical fractures, or cervicogenic headache) as assessed by clinical examination and medical history.

• Presence of at least three of the following signs and symptoms:

  1. Restricted cervical range of motion.
  2. Pain provoked or increased with neck movement or sustained neck postures.
  3. Palpable muscle tension or tenderness in the neck or upper back region.
  4. Referred pain or symptoms to the shoulders, upper back, or arms.
• Neck pain not attributed to a specific cause after careful evaluation, including imaging studies (e.g., X-ray, MRI, or CT scan) if deemed necessary by the clinician.

Exclusion Criteria:

• Serious pathology such as specific neck pain due to disc prolapse, tumor of the cervical spine, whiplash injury, cervical fractures, or cervicogenic headache.
• Any neurological signs consistent with nerve root compression.
• Prior surgery in the cervical region.
• Inability to comply with the exercise program or attend scheduled sessions.
• Contraindications to dermoneuromodulation techniques, such as active skin infections or severe inflammatory skin conditions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Supervised Exercise Program	Other: Supervised Exercise Program; Participants in the control group will receive a supervised exercise program that consists of three weekly sessions in addition to home exercises, over the course of four weeks. This program will include stabilization, flexing, extension, and rotation exercises for the cervical region and self-mobilization targeting the deep neck muscles. Participants will be instructed to perform the exercises at home three times a week in a manner that did not cause pain.
Experimental: Study Group; Combination of Exercise and Dermoneuromodulation Techniques	Other: Supervised Exercise Program plus Dermoneuromodulation Techniques; Participants in the study group will receive the same supervised exercise program as the control group, with home exercises, in addition to two dermoneuromodulation techniques for the Dorsal Cutaneous Nerve (C3-T1), which are the skin stretch technique and kitten technique. Patients in this group will receive 3 sessions/week for a total of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Numeric Pain Rating Scale (NPRS)	The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) to measure the intensity of pain.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in Neck Disability Index (NDI)	The NDI is a 10-item questionnaire used to measure functional disability related to neck pain. Each item is scored from 0 to 5, with a total possible score of 50. Higher scores indicate greater disability.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chnages in Pressure Pain Threshold (PPT)	The PPT is a measure of the minimum amount of pressure applied to a specific location that elicits pain. It is assessed using a handheld pressure algometer.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in cervical range of motion	The CROM is a measure of the movement in degrees around each axis (flexion, extension, lateral flexion, and rotation) of the cervical spine. It is assessed using a CROM device.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)	The FABQ is a 16-item questionnaire used to assess fear-avoidance beliefs related to physical activity and work in patients with musculoskeletal pain. The score ranges from 0 to 96, with higher scores indicating greater fear-avoidance beliefs.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in Pain Self-Efficacy Questionnaire (PSEQ)	The PSEQ is a 10-item questionnaire used to assess the confidence of individuals with chronic pain in performing activities while in pain. The score ranges from 0 to 60, with higher scores indicating greater pain self-efficacy.	Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 7, 2023
• Primary Completion (Estimated): March 10, 2024
• Study Completion (Estimated): March 10, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 012/07EGY10000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers of this study are committed to promoting open science and collaboration among researchers. As part of this commitment, we will share de-identified individual participant data (IPD) with other qualified researchers, upon request and in accordance with applicable regulations and ethical guidelines.
• IPD Sharing Time Frame: De-identified IPD will be available for sharing with other researchers starting six months after the publication of the primary study results and will remain accessible for a period of five years.
• IPD Sharing Access Criteria: mohamed.elmeligie@acu.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No