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Tactile Massage in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Per Wandell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00960674
First received: July 24, 2009
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

July 24, 2009
April 17, 2013
August 2007
September 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 2008 ] [ Designated as safety issue: No ]
HbA1c [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00960674 on ClinicalTrials.gov Archive Site
Quality of life by SF-36 [ Time Frame: 2008 ] [ Designated as safety issue: No ]
Quality of life by SF-36 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tactile Massage in Type 2 Diabetes
Effects on Type 2 Diabetes by Tactile Massage Compared to Relaxation With Relaxation Tape

Tactile massage is a gentle form of massage that probably exerts its effect through relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.

The study aimed at comparing the effect of tactile massage sessions for one hour given once a week for 10 weeks in comparison with relaxation through a relaxation CD performed once a week during 10 weeks. Primary outcome was HbA1c measured after completed intervention and after yet another 12 weeks. Secondary outcomes were quality of life by SF-36, other markers of metabolism (fasting glucose, insulin resistance by HOMA-model), inflammation (CRP, cytokines) and stress (cortisone, catecholamines).

Effects of different relaxation techniques on metabolic control in type 2 diabetes have been described. A pilot study indicated an effect by tactile massage, a Swedish form of gentle massage given in sessions of around one hours and including treatment of the whole body in general, on metabolic control measured as HbA1c and on plasma corticosteroids.

The present study aimed at studying the effects in a randomized controlled study, with patients provided with a relaxation cd available at pharmacies in Sweden. Power calculations found that 20-25 subjects in each group would be sufficient to show effect on HbA1c (0.8% vs 0.3%), but that 45-50 subjects would be needed to show clinical relevant effect on quality of life.

Patients aged 35-75 years with type 2 diabetes and BMI 25-30 and HbA1c 6-8%-units (Swedish standard, corresponding to 7-9%-units in DCCT standard) from primary health care centres in Stockholm County were invited to participate, and was randomly assigned to tactile massage or relaxation groups.

Exclusion criteria was heart or renal failure, treatment with insulin, problems with Swedish language. Besides, only subjects of Swedish ethnicity were included in this first study, in order to refine results and avoid confusional results.

Examination with laboratory tests, body examination and questionnaire, including SF-36 and questions on smoking, dietary and physical activity habits, was performed before intervention, after the 10 weeks examination and after yet another 12 weeks. Urine sampling on catecholamines and corticosteroids was performed, and blood tests on HbA1c, fasting glucose, insulin, CRP, cytokines (TNF-alpha, IL-6), adiponectin, leptin, ghrelin.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Procedure: Tactile massage
    Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.
    Other Name: Relaxation
  • Behavioral: Relaxation
    Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
  • Experimental: Tactile massage
    A gentle form of massage given once a week for three weeks
    Intervention: Procedure: Tactile massage
  • Experimental: Relaxation
    Relaxation (by the use of a CD with relaxation exercises used at least once a week for 10 weeks)
    Intervention: Behavioral: Relaxation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • 35-75 years
  • BMI 25-30, HbA1c (Swedish standard)
  • Oral antidiabetic treatment

Exclusion Criteria:

  • Heart failure
  • Renal failure
  • Insufficient knowledge in Swedish
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00960674
2007/414-31/4
No
Per Wandell, Karolinska Institutet
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Per E Wändell, MD, PhD Karolinska Institutet
Karolinska Institutet
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP