Paper 4/2012

Midwifery. 2011 Oct 5. [Epub ahead of print]

A randomised clinical trial of the effect of low-level laser therapy for perineal pain and healing after episiotomy: A pilot study.

Santos JD, Oliveira SM, Nobre MR, Aranha AC, Alvarenga MB.

OBJECTIVE: To evaluate the effects of low-level laser therapy for perineal pain and healing after episiotomy.

DESIGN: A double-blind, randomised, controlled clinical trial comparing perineal pain scores and episiotomy healing in women treated with low-level laser therapy (LLLT) and with the simulation of the treatment.

PARTICIPANTS: Fifty-two postpartum women who had had mediolateral episiotomies during their first normal delivery were randomly divided into two groups of 26: an experimental group and a control group.
INTERVENTION: In the experimental group, the women were treated with LLLT. Irradiation was applied at three points directly on the episiotomy after the suture and in three postpartum sessions: up to 2 hrs postpartum, between 20 and 24 hrs postpartum and between 40 and 48 hrs postpartum. The LLLT was performed with diode laser, with a wavelength of 660 nm (red light), spot size of 0.04 cm^2, energy density of 3.8 J/cm^2, radiant power of 15 mW and 10 s per point, which resulted in an energy of 0.15 J per point and a total energy of 0.45 J per session. The control group participants also underwent three treatment sessions, but without the emission of radiation (simulation group), to assess the possible effects of placebo treatment.

MAIN OUTCOMES: Perineal pain scores, rated on a scale from 0 to 10, were evaluated before and immediately after the irradiation in the three sessions. The healing process was assessed using the REEDA scale (Redness, Edema, Echymosis, Discharge Aproximation) before each laser therapy session and 15 and 20 days after the women’s discharge.

FINDINGS: Comparing the pain scores before and after the LLLT sessions, the experimental group presented a significant within-group reduction in mean pain scores after the second and third sessions (p=0.003 and p<0.001, respectively), and the control group showed a significant reduction after the first treatment simulation (p=0.043). However, the comparison of the perineal pain scores between the experimental and control groups indicated no statistical difference at any of the evaluated time points. There was no significant difference in perineal healing scores between the groups. All postpartum women approved of the low-level laser therapy.

CONCLUSION: This pilot study showed that LLLT did not accelerate episiotomy healing. Although there was a reduction in perineal pain mean scores in the experimental group, we cannot conclude that the laser relieved perineal pain. This study led to the suggestion of a new research proposal involving another irradiation protocol to evaluate LLLT’s effect on perineal pain relief.

Annal Comments:

 Fortunately, the authors provide details about the parameters, even in the PubMed abstract. It is therefore easy to pinpoint the reason behind the lack of effect: much too low energies! 0.15 J per point and three points = total of 0.45 J for wound healing. Here again we find the misunderstanding of “the dose”. 3.8 J/cm^2 is applied and this is close to 4 J/cm^2 which is a common “golden rule” for wound healing. But if the fiber is thin, “the dose” is reached very fast and with very low energies. At least ten times higher energies and a wider probe would have achieved a completely different result. So, same mistake as in Paper 1/2012. Where are the proper advisors and where are the qualified peer reviewers?