Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

Condition(s) studied

Investigational drug(s) / intervention(s)

Swedish massage: Participants receive Swedish massage once weekly for five consecutive weeks. Each 45-60-minute session is delivered by a licensed massage therapist using traditional Swedish techniques (kneading, gliding, and tapping) focusing on the back, shoulders, and neck. The intervention aims to promote relaxation and modulate stress-related biological systems. The study uses a single-group pre-post design to explore biological and psychological effects and feasibility.

Study summary

This pilot study evaluates potential biological and psychological effects of Swedish massage in adults with type 1 diabetes. Massage may influence stress-related mechanisms, such as hypothalamic-pituitary-adrenal (HPA) axis activity and inflammation, which are linked to impaired insulin sensitivity and glycemic control. Twenty participants with type 1 diabetes will receive weekly 45-60-minute Swedish massage sessions for five weeks. Biological outcomes include HbA1c, fasting glucose, copeptin, hs-CRP, IL-6, and TNF-α. Glycemic variability will be assessed using continuous glucose monitoring (CGM). Psychological outcomes include perceived stress (PSS-10) and anxiety (GAD-7). The study aims to explore feasibility, acceptability, and preliminary within-group effects on stress regulation and glycemic balance

Eligibility

Primary outcome measure(s)

• Concentration of HbA1c (mmol/mol) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. HbA1c (mmol/mol), measured from fasting blood samples. Lower values indicate improved glycemic control.
• Concentration of Copeptin (pmol/L) — Baseline and within 7 days after final massage (5 weeks).
  Limited efficacy outcome assessing preliminary within-group changes related to physiological stress. Copeptin measured from fasting serum samples. Lower concentrations indicate reduced stress system activation.
• Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation
• Concentration of Interleukin-6 (IL-6) (pg/mL) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation.
• Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.
• Glycemic variability (Coefficient of Variation, %), measured by CGM — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels.
• Time in Range (percentage of CGM readings between 3.9-10 mmol/L) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.
• Score on the Perceived Stress Scale-10 (PSS-10) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group psychological changes. The PSS-10 is a 10-item scale ranging 0-40, with higher scores indicating greater perceived stress.
• Score on the Generalized Anxiety Disorder-7 (GAD-7) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.
• Concentration of fasting plasma glucose (mmol/L) — Change from baseline to within 7 days after the fifth massage session (5 weeks).
  Limited efficacy outcome assessing preliminary within-group metabolic changes prior to a future randomized trial. Fasting plasma glucose (mmol/L), with lower values indicating improved glycemic control.

Trial sites (1)

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