Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes (TOHCD-D)

Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes (TOUCH-D): A Pilot Single-group Feasibility Study Evaluating Biological and Psychological Effects of Swedish Massage in Adults With Type 1 Diabetes.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Swedish massage

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Johansson, Professor/RN; Phone Number: 460700896548; Email: peter.b.johansson@liu.se
• Study Contact Backup: Name: Magnus Wijkman, PhD/MD; Email: magnus.wijkman@liu.se

Study Locations

• Sweden
  • Linköpings Universitet
    • Norrköping, Linköpings Universitet, Sweden, 601 74
      • Peter Johansson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years) with type 1 diabetes ≥ 1 year
• Able to attend two assessment visits at Vrinnevi Hospital
• Uses CGM or equivalent system
• Able to communicate in Swedish and provide consent

Exclusion Criteria:

• Severe diabetes complications (e.g., advanced neuropathy)
• Acute psychiatric disorder requiring treatment
• Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Swedish Massage; Participants receive Swedish massage once weekly for five consecutive weeks. Each session lasts 45-60 minutes and is delivered by a licensed massage therapist. Techniques include kneading, gliding, and tapping of soft tissues, focusing on the back, shoulders, and neck. The massage is designed to promote relaxation and modulate stress-related biological systems

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of HbA1c (mmol/mol)	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.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of Copeptin (pmol/L)	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.	Baseline and within 7 days after final massage (5 weeks).
Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L)	Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of Interleukin-6 (IL-6) (pg/mL)	Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM)	Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Glycemic variability (Coefficient of Variation, %), measured by CGM	Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Time in Range (percentage of CGM readings between 3.9-10 mmol/L)	Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Score on the Perceived Stress Scale-10 (PSS-10)	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.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Score on the Generalized Anxiety Disorder-7 (GAD-7)	Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.	Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of fasting plasma glucose (mmol/L)	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.	Change from baseline to within 7 days after the fifth massage session (5 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure	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. Clinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.	Baseline and within 7 days after the final massage session (5 weeks).
Change in Diastolic Blood Pressure	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. Clinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.	Baseline and within 7 days after the final massage session (5 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Metabolic and Inflammatory Markers	Additional biomarkers related to stress physiology, inflammation, or short-term glycemic control may be analyzed if relevant and assay-ready samples are available (e.g., additional cytokines, oxidative stress markers, or alternative glycemic indices). These outcomes are exploratory and not required for completion of the study.	Change from baseline to within 7 days after the fifth massage session (5 weeks).

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2025-05625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly due to the small sample size and sensitive clinical information. De-identified summary data may be available upon reasonable request to the principal investigator for research purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No