Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain
MeCNeck
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 13, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
December 11, 2025
August 1, 2025
2.2 years
August 4, 2025
December 10, 2025
Conditions
Keywords
Outcome Measures
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).
The measurement will take about 2 hours in total; pre and post intervention (5-6 weeks)
Secondary Outcomes (1)
Numerical pain scale
Takes about 20 seconds for the numeric rating scale; pre vs. post intervention (ca. 5-6 weeks)
Other Outcomes (4)
pain diary
5-6 weeks, 3-5 min / day
Neck Disability Index (NDI)
ca 6-10 min before and after the intervention (ca. 5-6 weeks)
DN4 (Douleur Neuropathique 4) questionnaire
10 min, before & after intervention (5-6 weeks)
- +1 more other outcomes
Study Arms (2)
Intense skin stimulation
EXPERIMENTALA vacuum pump provides a type of suction similar to cupping inducing intense manipulation of the skin. The vacuum can be adjusted according to applied suction and air flow. The participant will receive 6 therapy sessions of vacuum massage.
Light skin stimulation
ACTIVE COMPARATORTactile massage (soft touch) is a soft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues. The participants will receive 6 therapy sessions.
Interventions
Soft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues
Intense stimulation through suction of the skin and deeper layers
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- neurological symptoms
- having had a vertebral column surgery less than 12 months prior to the study,
- suffer from a congenital deformation of the spine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UiT, The Arctic University of Norway, Institute of Community Medicine, National Research Center in Complementary and Alternative Medicine, NAFKAM
Tromsø, Troms, 9013, Norway
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 13, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2030
Last Updated
December 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
The study is a small pilot study conducted in only one center in Tromso. Thus, there is no need to share individual participant data.