Health TrialsbyHealthPanel

SCENAR Therapy in Chronic Non-specific Neck Pain

ConditionsCervicalgiaNeck PainChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHopital Foch

About this trial

Shifting away from a medication-centered approach is a major public health priority, particularly in chronic pain management, where non-pharmacological therapies are recommended despite barriers such as limited evidence and low prescriber awareness.

SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation), an electrotherapy device, lacks robust randomized controlled trial data. A prior study showed effects in both active and placebo groups after a single session, supporting further investigation.

This study aims to assess whether repeated SCENAR sessions improve disability, mobility, and pain in patients with chronic neck pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged 18 years or older

Patients with chronic non-specific cervical spine pain, including cervicobrachial neuralgia, persisting for at least 3 months, with no identifiable underlying cause requiring specific treatment.

Patients who attended a pain clinic consultation or were referred to a pain specialist during hospitalization.

Neck Disability Index (NDI) score of at least 30% (≥15 points).

Disqualifiers

Pregnant women

Skin conditions preventing SCENAR use (wounds, recent scars, skin infections)

Initiation or change of analgesic treatment within 15 days prior to inclusion or during the study

Cervical pain related to inflammatory (spondyloarthropathy, rheumatoid arthritis, chondrocalcinosis), traumatic (fractures, dislocations), tumor-related (metastases, myeloma), infectious (spondylodiscitis), or neurological (intramedullary or posterior fossa tumor) causes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active SCENAR device therapy

    Device

    The session consists of applying the SCENAR device to the neck and surrounding cervical muscles.The device will be moved over the painful cervical area, with intensity adjusted according to patient feedback, in non-invasive sessions typically lasting 20 minutes.

  • Sham SCENAR device Therapy

    Device

    The SCENAR device will be applied to the painful cervical area without deliver electrical impulses.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Active SCENAR device therapyExperimental treatment 1 intervention
Group B: Sham SCENAR device TherapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Neck Disability Index (NDI) score

Change from baseline in the Neck Disability Index (NDI) score, assessed using the Neck Disability Index questionnaire. The NDI score is expressed as a percentage from 0% to 100%, with higher scores indicating greater neck-related disability.

Time frame
Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)

Secondary outcomes

1

Change from baseline in pain intensity at rest

Change from baseline in pain intensity at rest, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.

Time frame
Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
2

Change from baseline in pain intensity during movement

Change from baseline in pain intensity during movement, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.

Time frame
Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
3

Change from baseline in average pain intensity over the previous week

Change from baseline in the average pain intensity over the previous week, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.

Time frame
Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
4

Patient Global Impression of Change (PGIC) score

Patient Global Impression of Change (PGIC) score assessed 2 weeks after the last SCENAR session using a 0-to-10 numeric rating scale version of the PGIC questionnaire. Scores range from 0 ("markedly better") to 10 ("markedly worse"), with lower scores indicating greater perceived improvement.

Time frame
2 weeks after the last SCENAR session (approximately 10 weeks after baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hopital Foch

Lead sponsor

Fondation Apicil

Collaborator

Source ClinicalTrials.gov
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