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

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Healthy Control

Treatments: Other: Light Touch Control; Other: Swedish Massage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07190326

IRB_00155218

Details and patient eligibility

About

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.

Full description

This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects. The Primary Objective is to identify brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the neutral/fearful/angry faces task in normal control subjects. The secondary objective is to correlate changes in autonomic measures with resting state fMRI.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
• Subjects must have a permanent domicile
• Subjects must be able to comply with the research protocol
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion criteria

• 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)
• In the month before screening visit, excessive regular use of alcohol, as defined by either of the following, twice a month or more often: (a drink is one 5 ounce glass of wine or equivalent) a. ingestion of 5 drinks or more in a 2 hour period b. ingestion of 7 drinks or more in a 24 hour period
• At screening visit, CURRENTLY using any of the following interventions because of psychological distress (for example, for treatment of anxiety and/or other psychiatric condition). (These types of treatments are also prohibited during the study period.) a. participating in psychotherapy b. participating in CAM (complementary and alternative medical interventions) c. taking medication(s) (for example anxiolytics, antidepressants, and other psychotropic medications)
• Participant meets criteria for current suicidal or homicidal ideation
• Subjects who have massages on a regular basis. Regular massage usage will be defined as receiving on average 4 or more massages/year for the last 5 years
• Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
• History of head injury or neurological disorder, that in the investigator's opinion would impact the data or preclude safe and successful completion of the study - History of cancer that required chemotherapy and/or radiation treatment.
• General contraindication to MRI - Because MRI uses a very strong magnet, subjects cannot have metals in their bodies or certain medical conditions. Subjects cannot have a cardiac pacemaker; hearing aid; any other implant metal in their body or eyes, including pins, screws, shrapnel, plates, teeth braces, or dentures. Subjects cannot have tattoos on their head, such as eyeliner or other permanent makeup, as they may make it impossible to get clear and usable images.
• Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study.
• Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Swedish Massage Therapy

Experimental group

Description:

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.

Treatment:

Other: Swedish Massage Therapy

Light Touch Control

Active Comparator group

Description:

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:

Other: Light Touch Control