Tactile Massage in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Tactile massage; Relaxation
Intervention type(s): Procedure; Behavioral
Intervention description(s): Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.; Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
Other intervention name(s): Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment