Chronic Neck PainMeCNeckNCT07120659
Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain
A study testing soft touch massage and vacuum massage in people with Chronic Neck Pain, run by University of Tromso at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- soft touch massage and vacuum massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 27 Oct 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
UiT, The Arctic University of Norway, Institute of Community Medicine, National Research Center in Complementary and Alternative Medicine, NAFKAM
Tromsø, Troms, 9013
Frauke Musial, Ph.d., +47 45860762, frauke.musial@uit.no
Solveig Johanssen, MS, +47 77646867, solveig.johansson@uit.no
About this study
Official title: Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain: A Randomized Controlled Pilot Study Investigating Pain Mechanisms.
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.
Read the detailed description
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.
- Conditions
- Chronic Neck Pain
- Being tested
- soft touch massage, vacuum massage
- Keywords
- chronic neck pain, massage, soft touch massage, vacuum massage, cupping, quantitative sensory testing QST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft touch massageOther
Also called tactile massage
Soft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues
vacuum massageOther
Also called cupping massage
Intense stimulation through suction of the skin and deeper layers
| Study group | Role | What they receive |
|---|---|---|
| Intense skin stimulation | Experimental | 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. Receives: Other: vacuum massage |
| Light skin stimulation | Active comparator | 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. Receives: Other: soft touch massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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"
Measured: Takes about 20 seconds for the numeric rating scale; pre vs. post intervention (ca. 5-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start27 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre-post intervention of two different massage techniques
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frauke Musial, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120659
- Sponsor's protocol ID
- Ethics (REK) number 883588
- Other IDs
- Application 2023-51
- Acronym
- MeCNeck
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain: A Randomized Controlled Pilot Study Investigating Pain Mechanisms.
- ClinicalTrials.gov ID
- NCT07120659
- Acronym / sponsor ID
- MeCNeck / Ethics (REK) number 883588
- Conditions
- Chronic Neck Pain
- Keywords
- chronic neck pain, massage, soft touch massage, vacuum massage, cupping, quantitative sensory testing QST
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre-post intervention of two different massage techniques
| Arm | Type | Receives |
|---|---|---|
| Intense skin stimulation | Experimental | Other: vacuum massageA 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 comparator | Other: soft touch massageTactile 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft touch massageAlso: tactile massageSoft superficial massage which follows the anatomy of the body without penetrating into the deeper tissues | Other | Light skin stimulation |
| vacuum massageAlso: cupping massageIntense stimulation through suction of the skin and deeper layers | Other | Intense skin stimulation |
Primary outcome
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).
1 secondary outcome
Numerical pain scale
Time frame: Takes about 20 seconds for the numeric rating scale; pre vs. post intervention (ca. 5-6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft touch massage and vacuum massage in people with Chronic Neck Pain, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frauke Musial, Ph.d. (+47 45860762, frauke.musial@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Testing (QST) (time frame: The measurement will take about 2 hours in total; pre and post intervention (5-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.