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

NCT ID: NCT05893745

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2024-03-10

Brief Summary

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?

Conditions

Cervical Pain; Cervical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Supervised Exercise Program

Group Type: ACTIVE_COMPARATOR

Supervised Exercise Program

Intervention Type: OTHER

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.

Study Group

Combination of Exercise and Dermoneuromodulation Techniques

Group Type: EXPERIMENTAL

Supervised Exercise Program plus Dermoneuromodulation Techniques

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_DIRECTOR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed M ElMeligie, Ph.d

Role: CONTACT

mohamed.elmeligie@acu.edu.eg

+201064442032

Amal M Fawzy, Ph.d

Role: CONTACT

dr.amalfawzy@acu.edu.eg

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

012/07EGY10000

Identifier Type: -

Identifier Source: org_study_id