Vacuum Massage vs Tactile Massage for the Treatment of Chronic Neck Pain (MeCNeck)

University of Tromso (UiT)

Status: Enrolling

Conditions: Chronic Neck Pain

Treatments: Other: vacuum massage; Other: soft touch massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07120659

Application 2023-51 (Other Identifier)

Ethics (REK) number 883588

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intense skin stimulation

Experimental group

Description:

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.

Treatment:

Other: vacuum massage

Light skin stimulation

Active Comparator group

Description:

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.

Treatment:

Other: soft touch massage