Back to resultsEffectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
Primary Purpose
Cervical Pain, Cervical
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Supervised Exercise Program
Supervised Exercise Program plus Dermoneuromodulation Techniques
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Pain
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: 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. 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.
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Study Group
Arm Description
Supervised Exercise Program
Combination of Exercise and Dermoneuromodulation Techniques
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05893745
Brief Title
Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
Official Title
Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Anticipated)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain, Cervical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Supervised Exercise Program
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Combination of Exercise and Dermoneuromodulation Techniques
Intervention Type
Other
Intervention Name(s)
Supervised Exercise Program
Intervention Description
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
Intervention Name(s)
Supervised Exercise Program plus Dermoneuromodulation Techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Numeric Pain Rating Scale (NPRS)
Description
The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) to measure the intensity of pain.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Title
Changes in Neck Disability Index (NDI)
Description
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.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Secondary Outcome Measure Information:
Title
Chnages in Pressure Pain Threshold (PPT)
Description
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.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Title
Changes in cervical range of motion
Description
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.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Title
Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Title
Changes in Pain Self-Efficacy Questionnaire (PSEQ)
Description
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.
Time Frame
Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal M Fawzy, Ph.d
Email
dr.amalfawzy@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
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