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

University Hospital, Linkoeping

Status: Begins enrollment in 6 months

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Swedish massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07275086

2025-05625

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Swedish Massage

Experimental group

Description:

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

Treatment:

Behavioral: Swedish massage