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

NCT05893745 | Unknown

• 1 other identifier: 012/07EGY10000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Chnages in Pressure Pain Threshold (PPT)

  Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

• Changes in cervical range of motion

  Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

• Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

• Changes in Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Supervised Exercise Program

Other: Supervised Exercise Program

Study Group

EXPERIMENTAL

Combination of Exercise and Dermoneuromodulation Techniques

Other: Supervised Exercise Program plus Dermoneuromodulation Techniques

Interventions

Supervised Exercise Program 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.

Control Group

Supervised Exercise Program plus Dermoneuromodulation Techniques 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.

Study Group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Restricted cervical range of motion.
• Pain provoked or increased with neck movement or sustained neck postures.
• Palpable muscle tension or tenderness in the neck or upper back region.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Amal M Fawzy, Ph.d

CONTACT

dr.amalfawzy@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 7, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: mohamed.elmeligie@acu.edu.eg

Locations

EG (1)