Didem et al. (2005)

Didem et al. (2005)
Design: Randomized controlled trial (therapy), evidence level: 1−
Country: Turkey
Inclusion criteria:
Women with mild (increased limb circumference of up to 2 cm) to moderate (increased limb circumference of 2–5 cm) lymphoedema
Lymphoedema for at least 1 year
Exclusion criteria:
Obvious ongoing psychiatric illness
Severe pain in the axillary region
Severe cardiac disease
Uncontrolled hypertension (> 160/95)
Malignant disease
Population:
Number of patients = 53, age range 31 to 76 years, mean age = 58 years
Interventions:
Patients were randomised to one of the following regimes and taken to the treatment centre once a day, 3 days a week for 4 weeks:
  1. Complex decongestive therapy (CDT) (n = 27): lymph drainage, multi-layer compression bandage, elevation, remedial exercises and skin care.
  2. Standard physiotherapy (SP) (n = 26): bandage, elevation, head-neck & shoulder exercises and skin care.
A home program of bandage, skin care and walking was also recommended to all patients.
Outcomes:
Reduction of lymphoedema (in terms of circumference and volume), shoulder mobility.
Follow up:
Baseline assessments included a complete medical history and circumferential measurements of both affected and non-affected limbs. Arms were measured at eight points: 15, 15 and 20 cm above and below the elbow, at the wrist and in the hand. Limb volume was measured by water displacement. Shoulder mobility was also measured.

Follow-up assessments of these factors were made after treatment was concluded (4 weeks). Long term follow-up was not reported in this paper.
Results:
60.4% patients had moderate and 39.6% mild lymphoedema at baseline. The mean baseline limb volume was 580 ml and the mean duration of lymphoedema was 3.4 years across all patients.

Overall mean reduction in oedema after treatment (4 weeks):
CDP = 55.7%
SP = 36% (P < 0.05)
NB. Patient data for this outcome was reported for only one group but is not labelled with the identity of that group.

Reduction in range of motion in shoulder before treatment:
CDP = 48.1%
SP = 42.3%
Shoulder flexion and abduction were significantly increased in both groups (P < 0.05) but there was no improvement in external rotation. There was no significant difference between treatment groups in improved mobility.
General comments:
This paper presents a small RCT of women with unilateral lymphoedema secondary to breast cancer treatment. Participants were randomised by means of cards in unmarked envelopes to receive either CDT or standard physiotherapy regimes.

The data reporting is minimal and incomplete for both treatment groups. CDP appears to have made a significantly greater impact on lymphoedema reduction than the standard physiotherapy regime. Shoulder movement improved for all patients but there was no difference between treatment groups.

From: Chapter 6, Management of specific problems

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