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NCT Number: NCT07120659

Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain

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.

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UiT, The Arctic University of Norway, Institute of Community Medicine, National Research Center in Complementary and Alternative Medicine, NAFKAM

Tromsø, Troms, 9013, Norway

Location status: Recruiting

Location contact

Frauke Musial, Ph.d.

CONTACT

[email protected]

+47 45860762

Frauke Musial, Ph.d.

PRINCIPAL_INVESTIGATOR

Solveig Johanssen, MS

CONTACT

[email protected]

+47 77646867

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"

Exclusion criteria

  • 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.

Treatment and study plan

soft touch massage

Other

Soft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues

Other names: tactile massage

vacuum massage

Other

Intense stimulation through suction of the skin and deeper layers

Other names: cupping massage

Primary outcomes

  1. Quantitative Sensory Testing (QST)

    Time frame: The measurement will take about 2 hours in total; pre and post intervention (5-6 weeks)

    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).

Secondary outcomes

  1. Numerical pain scale

    Time frame: Takes about 20 seconds for the numeric rating scale; pre vs. post intervention (ca. 5-6 weeks)

    ranging from 0="no pain" to 100mm="worst pain imaginable"

Other outcomes

  1. pain diary

    Time frame: 5-6 weeks, 3-5 min / day

    daily characterisation of pain including medication

  2. Neck Disability Index (NDI)

    Time frame: ca 6-10 min before and after the intervention (ca. 5-6 weeks)

    Measures how neck pain has affects the patient's ability to manage in everyday life.

  3. DN4 (Douleur Neuropathique 4) questionnaire

    Time frame: 10 min, before & after intervention (5-6 weeks)

    diagnostic tool used to identify and assess neuropathic pain

  4. SF-36 health survey

    Time frame: ca. 5-10 min, before and after intervention period (5-6 weeks)

    Health-related quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Frauke Musial, Ph.d.

CONTACT

[email protected]

+47 45860762

Solveig Johansson, MS

CONTACT

[email protected]

+47 77646867

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Official study title

Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain: A Randomized Controlled Pilot Study Investigating Pain Mechanisms.

Acronym: MeCNeck

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 13, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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