Every now and then something unconventional comes to my attention. Management of pain is something that I have written about before and have been a proponent of things such as kangaroo care and breastfeeding to help improve responses to pain from common procedures like heel lances. Foot reflexology is a practice that is based on the notion that there are pressure points on our bodies that if pressed can elicit internal reactions in our organs. A map of such points for the foot is shown below.
There are strong proponents of this practice and I have to admit I was taken once for a session myself as a gift from someone. At the very least I felt like it was a good massage although the pituitary point of my big toe was a little to painful as I recall to endure. Whether or not my pituitary health benefited from this I guess I will never know.
What about foot reflexology for heel lances in NICU?
This is the question that a Turkish group of researchers decided to look at in their paper The effect of foot reflexology on procedural pain before heel lancing in neonates. The authors used what they called a quasi-experimental design in which they took 30 healthy neonates and provided them with foot reflexology for 20 minutes prior to heel lance vs 30 neonates who just had the heel lancing without prior reflexology. These again were healthy term neonates with a BW from 2500-4000g who were all breastfed for up to 30 minutes before the heel lance. For the reflexology group they received 15-20 minutes of reflexology while being held in their mother’s arms. The Neonatal infant pain scale was used before, during and after the procedure and was interpreted by viewing videos of the neonates by two nurses blinded to the groups that the babies were in. Although the study was not randomized this step at least attempted to remove bias from the interpretation of the facial expressions.
Analyzing the Results
From the above tables there are a few things the authors would like your attention drawn to. The first is that during the heel lance the pain scores were the same but afterwards babies who had reflexology had lower pain scores that were significantly so. The issue though with this is the scores themselves since it is a difference that while statistically significant is of unlikely clinical impact. For the NIPS scores, a score over 3 is suggestive of pain. Given that the control arm is 2.96 and the reflexology 1.80 with wide confidence intervals I am not sure if we can say these babies were in a lot of pain. During the procedure which is when I would have hoped to see a difference in pain scores there is none and with scores close to 7 for both groups let’s not kid ourselves. These babies were in pain with and without reflexology.
Looking at physiological changes there were none that came out as significant although after the intervention as with the NIPS score the heart rates were a little lower in 154 vs 147 but again what clinical significance is this?
Interestingly, crying afterwards was much less and just reached significance but again is this real or just a fluke finding given how many things they have looked at?
Finally, the big issue I suppose I have here is that the control group was not held by the mother prior to the intervention as they were in the reflexology group. I think it would have given some strength to the study had mothers held their infant in the control group for 15-20 minutes prior to the heel lance. Not sure why that wasn’t done.
Ok, I am a skeptic. As you might suspect I think that the real intervention here was mother’s holding their infants for 20 minutes on average before the procedure. Having said that is a gentle massage of the foot such a bad thing? The authors are talking about a future RCT and I guess that could be done but I think there are better options out there such as kangaroo care, breastfeeding, drops of mother’s milk in the cheek or even just the scent of mother’s milk that are great options for reducing pain the neonate.
Will have a look though if an RCT does happen as I could always be wrong…
I would consider myself fairly open minded when it comes to care in the NICU. I wouldn’t call myself a maverick or careless but I certainly am open to new techniques or technologies that may offer a better level of care for the babies in our unit. When it comes to “non-Western” concepts though such as therapeutic touch, chiropractic manipulations of infants and acupuncture (needle or otherwise) I have generally been a skeptic. I have written about such topics before with the most popular post being Laser acupuncture for neonatal abstinence syndrome. My conclusion there was that I was not a fan of the strategy but perhaps I could be more open to non traditional therapies.
This would appear to be the newest and perhaps strangest (to me at least) approach to pain relief that I have seen. I do love name of this study; the MAGNIFIC trial consisted of a pilot study on the use of auricular magnetic acupuncture to alleviate pain in the NICU from heel lances. The study was published in Acta Paediatrica this month; Magnetic Non-Invasive Acupuncture for Infant Comfort (MAGNIFIC) – A single-blinded randomized controlled pilot trial. The goal here was to measure pain scores using the PIPP scoring system for pain in the neonate before during and after a painful experience (heel lance) in the NICU. Being a pilot study it was small with only 20 needed per arm based on the power calculation to detect a 20% difference in scores. The intervention used small magnets placed at specific locations on the ear of the infant at least two hours before the heel lance was to occur. Before I get into the results, the authors of the study provide references to explain how the therapy works. Looking at the references I have to admit I was not able to obtain complete papers but the evidence is generally it would appear from adult patients. The explanation has to do with the magnetic field increasing blood flow to the area the magnet is applied to and in addition another reference suggests that there are affects the orbitofrontal and limbic regions which then impacts neurohormonal responses as seen in functional MRI. The evidence to support this is I would have thought would be pretty sparse but I was surprised to find a literature review on the subject that looked at 42 studies on the topic. The finding was that 88% of the studies reported a therapeutic effect. The conclusion though of the review was that the quality of the included studies was a bit sketchy for the most part so was not able to find that this should be a recommended therapy.
So what were the results?
Despite my clear skepticism what this study did well was that aside from the magnets, the intervention was the same. Twenty one babies received the magnetic treatments vs 19 placebo. There was a difference in the gestational ages of the babies with the magnet treated infants being about two weeks older (35 vs 33 weeks). What difference that might in and of itself have on the PIPPs scoring I am not sure. The stickers were applied to the ears with and without magnets in a randomized fashion and the nurses instructed to score them using the PIPP scoring system. Interestingly, as per their unit policy all babies received sucrose as well before the intervention of a heel lance so I suppose the information gleaned here would be the use of magnets as an adjunctive treatment. No difference was noted in the two groups before and after the heel lance but during the procedure the magnet treated infants had a difference in means (SD): 5.9 (3.7) v 8.3 (4.7), p=0.04). No differences were found in secondary measures such as HR or saturation and no adverse effects were noted. The authors conclusions were that it was feasible and appears safe and as with most pilot studies warrants further larger studies to verify the results.
Should we run out and buy it?
One of the issues I have with the study is that in the introduction they mention that this treatment might be useful where kangaroo care (KC) is not such as a critically ill infant. Having placed infants who are quite sick in KC and watched wonderful stability arise I am not sure if the unit in question under utilizes this important modality for comfort.
The second and perhaps biggest issue I have here is that although the primary outcome was reached it does seem that there was some fishing going on here. By that I mean there were three PIPP scores examined (before, during and after) and one barely reached statistical significance. My hunch is that indeed this was reached by chance rather than it being a real difference.
The last concern is that while the intervention was done in a blinded and randomized fashion, the evidence supporting the use of this in the first place is not strong. Taking this into account and adding the previous concern in as well and I have strong doubts that this is indeed “for real”. I doubt this will be the last we will hear about it and while my skepticism continues I have to admit if a larger study is produced I will be willing and interested to read it.
Before we get into critiquing such a study it is worth explaining what laser acupuncture is. From the website acupuncture today I found the following background:
“In 1991, a study was done in Novosibirsk, Russia that applied directly to the study of acupuncture. Researchers shined light on various parts of the body and found that light traveled under the skin to other acupuncture points, but it didn’t travel to places that were not on acupuncture meridians. It appears that the body contains a sort of fiber optic network—where light enters an acupuncture point, travels through the meridian and can be detected at other places along the meridian with a sensitive photon detector. This is a fascinating study showing how light is actually received, used and transmitted throughout the body.”
This study compared patients receiving treatment for NAS with morphine and phenobarbital and compared 14 in each group on a blinded fashion to laser acupuncture or nothing in addition to the standard regimen. They avoided the need for a placebo in that the intervention was done by the health care provider and then a separate person calculated a pain score who was blind to whether the laser had been provided or not. By blinding the people scoring they hoped to address the criticism that would be present had the study been unblinded. The acupuncture was performed daily at five ear and four body points bilaterally with the primary outcome being duration of oral opiate use. The authors found a reduction in days of opiate treatment but being a small study it would be considered a pilot at best. The results were 28 days (22 to 33) vs 39 days (32 to 48), respectively, P =.019 and the authors make a comment that phenobarb levels were similar between the groups as well but with overall shorter lengths of stay of 35 days (25 to 47) vs 50 days (36 to 56), respectively, P = .048. There are several issues with the study though and they are as follows. Yes, the light therapy was provided behind a closed door but how do we know that the providers truly kept it a secret during the whole stay of the patient? What medications were the mothers taking and at what doses and for what duration? Was the exposure between groups really the same? Also there was no standard means of weaning that I can see so how do we know by chance that the difference is simply who was on at the time with respect to physician deciding on aggressiveness of weaning. Another issue is that women on replacement medications such as methadone or suboxone were excluded as were women with polysubstance abuse. How close to our patient population really were these patients? Lastly, nearly significant was a preponderance of males in the conventional group and we all know how males generally do compared to females in most studies. Nonetheless it is a exciting study to imagine an effect from and that is what the authors I think were banking on.
What about laser acupuncture for treatment of pain?
One other study comparing sucrose to laser acupuncture for prevention of pain with heel lances. In this study of 42 infants randomized to the intervention or sucrose the authors concluded that sucrose was superior to acupuncture for managing pain from heel lancing. This study did not have a third arm in which no treatment was given (likely due to it being unethical) so what we can’t say for sure is whether laser is better than nothing.
Personally I find a bit of a leap to believe that shining a light through the skin would have an effect on pain perception by anyone. I can certainly understand the concept of putting a needle into tissue or applying pressure no different from the effect of rubbing ones temples when they have a headache (works for me at least). The Chemistry major in me though has trouble with the effect of photons passing through tissue even if directed at acupuncture points. Having said that the only positive thing I can say is that a quick search for such instruments shows them to be commercially available and as cheap as $50 or so. I have no doubt there are people who will read this RCT and be impressed with its additional purported impact on NAS and thankfully if they do decide to pursue this intervention they will not have spent a fortune on it. Money in health care should be directed to what works to help patients and the skeptic in me just isn’t buying this even if it appeals to my curiosity with non-invasive strategies.
Sucrose given to newborns prior to anticipated painful procedures has been used for many years now. The pooled evidence as presented by the Cochrane Database of Systematic Reviews concludes that “Sucrose is safe and effective for reducing procedural pain from single painful events (heel lance, venepuncture).” As care providers for newborns in an Intensive care setting we have become accustomed to providing this sugar to infants prior to such procedures and there is no question that we note the benefit in both subjective assessment of pain and when using more objective scoring systems.
It is for this reason that I read with great interest the article by Gray L et al Pediatrics entitled Sucrose and Warmth for Analgesia in Healthy Newborns: An RCT. The study included 29 infants roughly half of which were randomized to sucrose 1 mL/kg of a 25% solution (Sweet-Ease) and the other to the same solution plus placement on an overhead warmer prior to Hepatitis B immunization. The results demonstrated a reduction in crying with both interventions compared to the sucrose alone as shown in the following figure.
An additional finding was that of a dampening of heart rate acceleration if the infant received warmth as well. There is no question that the combination of warmth and sucrose is superior to providing sucrose alone but is the study relevant today?
The infants in this paper were recruited in 2008 at a time when we as a profession were not as accustomed to Kangaroo Care or Skin to Skin care as it is also known. In the study the overhead warmer was used as a substitute for Skin to Skin care but in 2016 would we do this? Perhaps if the mother was unavailable but certainly not if we could put the infant against the mother’s chest and provide sucrose. While the study has its merits I think it fails a critical test in order to apply it in our own practice. The question must always be asked no matter what the size of an effect “Can the results of the study be applied to my patient population?”
I fear in this case the answer is no for most of our infants. The paper serves as a good reminder that while results of a study may be valid, they might just not be useful in your own practice.
What the future will hold I don’t know but if you are looking for another option for pain relief other than acetaminophen or ibuprofen you may wish to ask your practitioner about a little sugar next time.