Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

NCT ID: NCT07275086

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2027-02-01

Brief 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

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Swedish massage

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Peter Johansson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peter Johansson

Norrköping, Linköpings Universitet, Sweden

Countries

Sweden

Central Contacts

Peter Johansson, Professor/RN

Role: CONTACT

peter.b.johansson@liu.se

460700896548

Magnus Wijkman, PhD/MD

Role: CONTACT

magnus.wijkman@liu.se

Other Identifiers

2025-05625

Identifier Type: -

Identifier Source: org_study_id