NCT07120659

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress10%
Oct 2025Dec 2030

First Submitted

Initial submission to the registry

August 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 27, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

August 4, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

chronic neck painmassagesoft touch massagevacuum massagecuppingquantitative sensory testing QST

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

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.

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.

Other: soft touch massage

Interventions

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

Also known as: tactile massage
Light skin stimulation

Intense stimulation through suction of the skin and deeper layers

Also known as: cupping massage
Intense skin stimulation

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Central Study Contacts

Frauke Musial, Ph.d.

CONTACT

Solveig Johansson, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: pre-post intervention of two different massage techniques
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.

Locations