Pelvic Health PHODA - What is it and how can it help?

Finding the “right” areas to address when working with any patient is a challenging task for a health care provider. What is important to that patient? In what area can we work to make progress so that there is a meaningful change and impact for that individual? When the patient is open, shares, and can pick out a specific activity or experience in which they would love to engage in again or for the first time all I must do as the provider is listen. But what can I do when the patient cannot articulate their goals because there are too many things, or it has been so long that all they want is for the dysfunction or pain to end?

That is when I use the Pelvic Health PHODA (Photographs of Daily Activities). Sandy first gave me the idea to create a PHODA for pelvic health after we discussed the original version during a course by Cory Blickenstaff. She had been wanting to have one for several years but had not yet found the opportunity to create the cards. A little while later I found myself stranded on my way back to the clinic from my home in Northern Michigan just after Christmas. My car broke down and instead of going to work for the next few days I headed back home until I could find an alternate route to Chicago. When I told Sandy about being stranded she said, “Work on PHODA”.

To begin I did some research on what versions of the PHODA exist and how they are used. It has been validated for use on patients with high and low levels of Kinesiophobia (Trost et al, 2008) where the modified version was used. This version has 20 photographs compared to the 100 in the original version. There is also a version that was recently validated for use with the pediatric population (Verbunt et al, 2015). This version looked at activities specifically important to youth with musculoskeletal pain and how harmful they perceived certain activities.

During my search I found the modified version, the original was by Kugler et al, for download on-line. My impressions after un-zipping, installing, and using the file were not positive. The background is a horrid mustard-yellow, the pictures are small and outdated, and you have to use all 40 images in order to complete the test. The experience was off-putting with the nauseating color scheme and the repetition of similar images that all had to be placed on a scale.

What I envisioned was a tool that would allow patients to pick images out that resonated with them, how ever many they would like, and then lay them out in terms of easiest to hardest. This then serves as a tool for the clinician to focus treatment and for the patient to zero in on what they are looking for from physical therapy. So I set about finding pictures of a variety of daily activities that patients have reported loving, hating, or wishing they could do that thing.

When I use them with patients I say, “Here are some photographs of activities. Please pick out ones that appeal to you. Then place them from no difficulty to very challenging based on your reason for coming to physical therapy. I don’t care how many you chose but I would like at least one at each end of the spectrum. Then we will talk about why you chose each card.” I want them to feel free to pick 2 or 54 cards. Then I can use their own choices as a guide for treatment.

Eventually I would love to validate these cards and their specific use for the treatment of pelvic dysfunction. Bronwyn Thompson, PhD, MSc (Psych) 1st Class Hons, DipOT, Registered Occupational Therapist has a great article on validating PHODA for use in New Zealand.  For now I use them in conjunction with other outcome measures using the photos to gain insight and target my treatments to best serve each individual who comes through the door.

Hannah Mulder is a 3rd year DPT student from Rosalind Franklin University, doing an amazing job of applying research to her practice, as well as making excellent snacks for the courses at Entropy.  If you're interested in a set of your own PHODA for the Pelvis cards, you can buy a set now!!

References:

Trost Z, France C, Thomas J. Examination of the photograph series of daily activities (PHODA) scale in chronic low back pain patients with high and low kinesiophobia. Pain (03043959) [serial online]. February 2009;141(3):276-282. Available from: CINAHL Complete, Ipswich, MA. Accessed January 22, 2018.

Verbunt J, Nijhuis A, Goossens M, et al. The psychometric characteristics of an assessment instrument for perceived harmfulness in adolescents with musculoskeletal pain (PHODA-youth). European Journal Of Pain [serial online]. May 2015;19(5):695-705. Available from: PsycINFO, Ipswich, MA. Accessed January 22, 2018.

Kugler K, Wijn J, Geilen M, de Jong J, Vlaeyen JWS: The Photograph series of Daily Activities (PHODA). CD-rom version 1.0. Institute for Rehabilitation Research and School for Physiotherapy Heerlen, The Netherlands, 1999

HealthSkills Blog

Do Vaginas Need Rejuvenating?

Laser therapy for vaginal rejuvenation is a hot (and profitable) intervention.  

Lasers themselves are alluring.  They hold a promise of more power than anything we can do for ourselves. In health care, they have many uses – some with good evidence, others not.  The use of lasers for improving circulation and tissue health in the vagina is a growing trend.  Is it more than an expensive, flashy, placebo?

A British morning show did an expose with a live demonstration1.  What is the attraction and what bring women to pay roughly $1200/visit for vaginal laser treatments?  

Women are seeking help for:
Vaginal dryness
Painful intercourse
Vaginal skin irritation
Appearance

Some women experience uncomfortable symptoms from the hormonal changes that occur with peri-menopause and menopause. The lasers are promoted to women as a non-hormonal treatment to restore vaginal tissue hydration and mobility.  They are also promoted as a way to change the appearance of the labia and make the tissues “more firm” as a “Laser of Youth” for lady bits. 

I am left with many questions:
Is it beneficial for women to seek an eternal youthful appears to their labia for a self-esteem perspective?

What are the long-term effects for the tissues?

Does laser therapy live up to the claims? 

Is the effect the same or better as the hormonal therapy and/or topical ointments currently used to relieve these problems?

We don’t know the answers to these questions because there is no evidence supporting the claims, and there is evidence showing little change in the tissues following treatment.

Laser therapy as a treatment modality for genitourinary syndrome of menopause: A critical appraisal was published in January of 2017 on the current evidence on the treatment of vulvovaginal atrophy. 2 Neither the Mona Lisa (CO2 laser) or the Yr:YEG near infrared laser have undergone testing compared to a placebo and none of the studies found by the authors in their literature review used any control group.   The 220 women included in the review completed symptoms questionnaires as the measure of effectiveness.  There were no negative effects and the treatments are considered safe.  What we don’t know is if the laser treatment is the reason for the improvement.

I applaud the authors for recommending a placebo-controlled trial. 

They found no studies have been done on the lasers and that the term Genitourinary Syndrome of menopause (GSM) includes a variety of symptoms that have different causes and treatment options.  This paper addresses the older term “vulvovaginal atrophy” which included vaginal dryness and irritation – subjective symptoms most commonly treated with hormonal therapy and/or topical ointments.

Treatment typically is three 5-10 min sessions, administered 4 – 6 weeks apart.

The authors report that “some participants <in the literature> show improvement after one treatment procedure while some show improvement after 2 – 3 treatment procedures.” 2 It is important to note that what is improved, by how much, and how that is determined is not defined.

220 women are included in the review. There are no RCTs and the review included 3 case series without control groups.  The paper refers to “subjective cure rates” based on participant self-report on questionnaires.  The studies followed up for only three months, and no long-term data is available.  The authors concluded, “Lasers have become a very expensive option for the treatment of symptomatic GSM, without a single trial comparing active laser treatment to placebo”2

The two types of laser included in this review are Mona Lisa (CO2) and ER:YEG (near infra-red).  The Mona Lisa laser is ablative, and the ER:YEG is non-ablative. There are no other substatantive differences. This treatment is not covered by insurance (remember, there are no RCTs showing effectiveness and there is no long-term data) and costs between $1000 - $1500/visit.2 The Mona Lisa is a CO2 laser designed to stimulate and promote the regeneration of collagen fibers and to restore hydration and elasticity within the vaginal mucosa. The Er: YAG  is a laser with a wavelength of 2,940 nm, which emits laser energy in the mid-infrared region. This laser has 10 to 15 times the affinity for water absorption than the CO2 laser at a wavelength of 10,600 nm. This treatment approach enables a deeper secondary thermal effect and controlled heating of the target mucous membrane of the vaginal wall.

These lasers have been cleared for clinical use by the FDA and are being marketed both to healthcare practitioners and to consumers.  The women seeking this treatment for pain are desperate for help.  This puts the burden of proof of effectiveness and efficacy firmly on the providers. It is also important to point out that we do not know if it is effective long-term, or if it is more than an expensive placebo.  It MAY be effective!

What is the harm?  At this point, the harm is two-fold:

1)   The cost is a burden for the person in need.

2)   The person in need is IN Need.  This is not vanity treatment; this is to fill a need for comfort (in order to move without pain, rubbing, dryness) and self-confidence.

My hesitancy as a health care provider in promoting this option is that we do not have a placebo-controlled study, and we do not know the long-term effects.  It may be that this is a much-needed relief and a viable treatment.  Without a large, long-term, randomized, placebo-controlled study to assess safety and efficacy we do not know.  Is this better than low-dose local hormones for tissue health?  Is this better than a combination of hormones and moisturizers for dryness?  We don’t know. 
What role with the new selective estrogen receptor modulator play (SERM)?  We don’t know.

How many times can I say “We do not know”? One more!

An additional problem is with definitions and that leads to a challenge in determining effectiveness.

What is normal in the aging vagina? 

Is aging a pathology or something to be adapted to?

Define “improved” in these studies – would that carry over as a predictive value for another person?

My hope is that these authors continue to study and continue to push for the independent placebo-controlled randomized trial (a straightforward study design).  For women considering the procedure, I urge caution and clear discussions with your healthcare team for all your choices.  The jury is still out on this one.

Sandy Hilton, PT, DPT, MS

1. http://metro.co.uk/2017/09/20/woman-undergoes-designer-vagina-surgery-on-live-tv-its-visibly-different-6942159/ Accessed 15 January 2018.

2. Arunkalaivanan, A, Kaur, H Onuma, O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: A critical appraisal.Int Urogynelcol J January 19, 2017.