An interventional study of soft touch massage and vacuum massage in Chronic Neck Pain, sponsored by University of Tromso. Recruiting at 1 site in Norway. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by University of Tromso · Not applicable, Interventional, and Other
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.
Chronic pain imposes a severe burden for the individuals suffering from it as well as for society. A report from the Norwegian Institute of Public Health from April 2019 summarizes that "Chronic pain affects about 30 per cent of the adult Norwegian population and is the most common reason for long-term sick leave and disability benefit". At the same time there is increasing awareness, that the potential for addiction for some of the pain medications has become a serious public health challenge as well. Thus, there is an urgent need for non-pharmacological interventions, however, most of these interventions belong to the spectrum of complementary and alternative medicine and are often not available through the conventional healthcare system. The fact that the biomechanisms for many of these therapies are unclear, imposes a challenge for the conduction of clinical trials as well as for the acceptance of theses complementary therapies. Thus, the aim of this randomized controlled pilot study is to investigate the effect of massage on chronic neck pain with regard to their mechanism of action. Two types of massage, cupping massage (CM, intense) vs tactile massage (TM, soft) are compared, which differ regarding the intensity of skin receptor stimulation. Quantitative sensory testing (QST) of the pain pathway will be used as a psychophysiological, mechanistic biomarker. Complete QST has rarely been used to evaluate complementary therapies for chronic pain, however a NFR funded feasibility pilot study (case series) on cupping massage and QST has recently been conducted in Jena, Germany, by this group of applicants. The current study will produce pilot data on QST that can be used for sample size estimation in a future clinical trial. A total of n=60 patients with chronic neck pain will be recruited and randomized to either CM or TM. Patients will receive a total of 6 treatment sessions once per week. QST will be measured before and after the treatment. Since QST can describe therapy induced changes in the neuronal pain pathway, it will contribute fundamentally to our understanding of the mechanisms of action of massage and related interventions. This will i) help to tailor massage therapy to the individual needs of patients and thus improve care ii) which will in turn enhance the quality of clinical trials and iii) foster the acceptance of non-pharmacological interventions for the treatment of pain, which may iv) support their integration into conventional care and make these therapies available for the rather large population in need.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
A 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.
Other: vacuum massage
Tactile 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.
Other: soft touch massage
Soft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues
Also known as: tactile massage
Intense stimulation through suction of the skin and deeper layers
Also known as: cupping massage
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)
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)
pain diary
daily characterisation of pain including medication
Time frame: 5-6 weeks, 3-5 min / day
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)
DN4 (Douleur Neuropathique 4) questionnaire
diagnostic tool used to identify and assess neuropathic pain
Time frame: 10 min, before & after intervention (5-6 weeks)
SF-36 health survey
Health-related quality of life
Time frame: ca. 5-10 min, before and after intervention period (5-6 weeks)
Plan to share: No — The study is a small pilot study conducted in only one center in Tromso. Thus, there is no need to share individual participant data.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.
Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 26 months is above that.
Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
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University of Tromso