Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain
ConditionChronic Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of Tromso
About this trial
Chronic pain significantly impacts individuals and society, with about 30% of Norwegian adults affected, making it the leading cause of long-term sick leave and disability benefits. Concerns over addiction to pain medications highlight the need for non-pharmacological treatments, though many such therapies, often complementary or alternative, are not widely available in conventional healthcare. Unclear biomechanisms of these therapies pose challenges for clinical trials and acceptance.
This pilot study aims to explore the effects of two types of massage-cupping massage (CM, intense) and tactile massage (TM, soft)-on chronic neck pain, focusing on their mechanisms of action. Quantitative sensory testing (QST) will be used as a biomarker to assess changes in the pain pathway. A previous feasibility study on CM and QST conducted in Germany informs this research.
The study will recruit 60 patients with chronic neck pain, randomized to CM or TM, with six weekly treatment sessions. QST will be measured before and after treatment to understand therapy-induced changes in the pain pathway. Findings will help tailor massage therapies to individual needs, improve clinical trial quality, and promote the integration of non-pharmacological treatments into conventional care, benefiting a large population in need.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suffer from non-specific neck pain persisting at least 3 months
mean pain intensity ≥ 50 on a 0-100 mm visual analogue scale (NRS) with "0" meaning "no pain" and "100" meaning "worst pain imaginable"
Disqualifiers
neurological symptoms
having had a vertebral column surgery less than 12 months prior to the study,
have received TENS, acupuncture, osteopathy, or a chiropractic maneuver or infiltration at the area within 4 weeks prior to the inclusion in the study
suffer from a congenital deformation of the spine.
Trial design
Design model
Parallel
Treatments tested in this trial
soft touch massage
Other interventionSoft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues
vacuum massage
Other interventionIntense stimulation through suction of the skin and deeper layers
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intense skin stimulationExperimental treatment 1 intervention
Group B: Light skin stimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quantitative Sensory Testing (QST)
Sensory testing will be performed according to the standard protocol of the German Research Network on Neuropathic Pain (DFNS) and all measurements will be carried out by the same examiner at a defined point of the trapezius muscle on the site with the worst pain, and the foot and the hand as reference areas (norms exist for hand, foot, back and face).
Time frame
The measurement will take about 2 hours in total; pre and post intervention (5-6 weeks)Secondary outcomes
1
Numerical pain scale
ranging from 0="no pain" to 100mm="worst pain imaginable"
Time frame
Takes about 20 seconds for the numeric rating scale; pre vs. post intervention (ca. 5-6 weeks)Other outcomes
1
pain diary
daily characterisation of pain including medication
Time frame
5-6 weeks, 3-5 min / day2
Neck Disability Index (NDI)
Measures how neck pain has affects the patient's ability to manage in everyday life.
Time frame
ca 6-10 min before and after the intervention (ca. 5-6 weeks)3
DN4 (Douleur Neuropathique 4) questionnaire
diagnostic tool used to identify and assess neuropathic pain
Time frame
10 min, before & after intervention (5-6 weeks)4
SF-36 health survey
Health-related quality of life
Time frame
ca. 5-10 min, before and after intervention period (5-6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov