Cervical PainNCT05893745
Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
A study testing Supervised Exercise Program and Supervised Exercise Program plus Dermoneuromodulation Techniques in people with Cervical Pain and Cervical, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Cervical Pain, Cervical
- What is being tested?
- Supervised Exercise Program and Supervised Exercise Program plus Dermoneuromodulation Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2023to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Amal M Fawzy, Ph.d contact
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
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.
Read more
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
- Being tested
- Supervised Exercise Program, Supervised Exercise Program plus Dermoneuromodulation Techniques
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise ProgramOther
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.
Supervised Exercise Program plus Dermoneuromodulation TechniquesOther
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 | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Supervised Exercise Program Receives: Other: Supervised Exercise Program |
| Study Group | Experimental | Combination of Exercise and Dermoneuromodulation Techniques Receives: Other: Supervised Exercise Program plus Dermoneuromodulation Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start7 Jun 2023 (estimated)
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893745
- Sponsor's protocol ID
- 012/07EGY10000
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05893745
- Acronym / sponsor ID
- 012/07EGY10000
- Conditions
- Cervical Pain, Cervical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (estimated)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Supervised Exercise ProgramSupervised Exercise Program |
| Study Group | Experimental | Other: Supervised Exercise Program plus Dermoneuromodulation TechniquesCombination of Exercise and Dermoneuromodulation Techniques |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise ProgramParticipants 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. | Other | Control Group |
| Supervised Exercise Program plus Dermoneuromodulation TechniquesParticipants 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. | Other | Study Group |
Primary outcome
Changes in Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
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)
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
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.
4 secondary outcomes
Chnages in Pressure Pain Threshold (PPT)
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in cervical range of motion
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Changes in Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal M Fawzy, Ph.d contact
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Program and Supervised Exercise Program plus Dermoneuromodulation Techniques in people with Cervical Pain and Cervical, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Numeric Pain Rating Scale (NPRS) (time frame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.