Clinical trial NCT05893745: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Pain
Cervical
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: Changes in Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
measure: Changes in Neck Disability Index (NDI)
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Secondary outcomes:
measure: Chnages in Pressure Pain Threshold (PPT)
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
measure: Changes in cervical range of motion
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
measure: Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
measure: Changes in Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References: