Health TrialsbyHealthPanel

Massage: Neuroimaging and Correlates of Response - 6-week Study

ConditionHealthy Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Utah

About this trial

This study will help find out if massage and touch therapies change brain activity and reduce the symptoms of anxiety. Massage therapy has well known health benefits. This study will help to learn if these therapies reduce the symptoms of anxiety by changing brain activity. Participation in the study will last about 8 weeks. This is a randomized research study. "Randomized" means that participants will be assigned to a study group by chance, like flipping a coin. Participants will be randomized into one of two study groups, and will have an equal chance of being placed in one of the groups: - Swedish massage therapy twice per week for 6 weeks - Light touch therapy twice per week for 6 weeks At each study, the study staff ask about life stressors, medical health, medicine use, and illicit substance use over the past week. The study uses magnetic resonance imaging (MRI) as well as functional MRI (fMRI) to look at the structure and activation of the brain. Participants will undergo two brain scanning sessions, one before the first intervention and one immediately after the last Swedish massage or light touch therapy. The scans will last approximately 45 minutes. During the brain scanning sessions, information on heart rate, blood pressure, temperature and breathing will also be collected.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female

aged ≥ 18 and < 65 years old

Medically stable

Psychiatrically healthy as demonstrated by a structured clinical interview that elicits no previous or current Axis I psychopathology

Disqualifiers

Current (within 3 months of screening visit) nicotine use, illicit drug use, or long-term medication use that, in the opinion of the investigator, could alter the results of the study

Pregnancy (per participant report, pregnancy testing not done for study)

Usually is asleep during the daytime (ie due to Working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms

Current (past month) rigorous dieting (defined as <1200 calories per day for ≥2 consecutive days)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Swedish Massage Therapy

    Other intervention

    The therapist uses non-aromatic cream to facilitate making long strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then re-draped before moving to another part. The primary techniques used in the research protocol therapy are effleurage, petrissage, kneading, tapotement and thumb friction. These techniques are performed in a very precise, carefully elaborated manner. The session starts with the subject fully draped in a prone position on the massage table and after approximately 22 minutes the subject is instructed to turn to the supine position. Finally, the therapist moves to the head area of the subject, begins working on the shoulders, neck and head using effleurage and thumb friction, and concludes by using light tapotement on the head. The total time for the entire massage is 45 minutes. Subjects randomized to SMT will undergo two sessions per week for 6-weeks.

  • Light Touch Control

    Other intervention

    The Light Touch Control protocol entails the same duration and sequence of procedures as the massage protocol, except that the therapist employs only light-touch hand placement on the subject's body. This condition isolates the effect of the mechanical intervention of SMT. Subjects randomized to LT will undergo two sessions per week for 6-weeks.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Swedish Massage TherapyExperimental treatment 1 intervention
Group B: Light Touch ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in rsFC

Change in resting state functional activity in brain networks activated by SMT vs. LT using resting state fMRI in healthy non-psychiatric control subjects will be calculated at week 6, after the last intervention relative to baseline.

Time frame
6-weeks

Secondary outcomes

1

Change in neuronal connectivity in response to fearful/angry faces task

pre-to-post-intervention change in neuronal connectivity in response to fearful/angry faces task during fMRI.

Time frame
6-weeks
2

Correlation of changes in autonomic measures (heart rate variability, heart rate, pulse) with resting state neuronal functional connectivity in response to fearful/angry faces task during fMRI

Change in autonomic activity (heart rate variability, heart rate, pulse) will be correlated with changes in resting state functional connectivity in response to the fearful/angry faces task during fMRI.

Time frame
Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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