Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore,

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE AND ADDRESS / NEHA GUPTE
‘SAMADHAN’ HOUSE NO.23/3, BEHIND DR.DESAI’S HOSPITAL, RAJASHIVAJI ROAD, VIRAR (W). 401303
2 / NAME OF THE INSTITUTION / KRUPANIDHI COLLEGE OF PHYSIOTHERAPY , BANGALORE
3 / COURSE OF STUDY AND SUBJECT / MASTER OF PHYSIOTHERAPY
(Musculoskeletal disorders & Sports physiotherapy)
4 / DATE OF ADMISSION
5
6 / TITLE OF THE TOPIC
“EFFECTIVENESS OF NIGHT SPLINT OVER ULTRASOUD ON PAIN AND FUNCTIONAL ABILITIES IN SUBECTS WITH PLANTAR FASCITIS - A RANDOMIZED EXPERIMENTAL STUDY”
BRIEF RESUME OF INTENDED WORK :
INTRODUCTION:
Thefoot(pluralfeet) is ananatomicalstructure found in manyvertebrates. It is the terminal portion of a limb which bears weight and allows locomotion.
The human foot and ankle is a strong and complex mechanical structure containing exactly 26bones, 33joints.
The five bones of themidfoot, form thearches of the footwhich serves as a shock absorber. The midfoot is connected to the hind- and fore-foot by muscles and theplantar fascia .[1]
Plantar fascia contributes to support of arch of foot by acting as a tie –rod, where it undergoes tension when he foot bears the weight. One biomechanical model estimated, it carries as much as 14% of total load of foot.[2 ]Plantar fascia also has an important role in dynamic function during gait. During mid stance phase fascia behaves like spring, which may assist in conserving energy. Plantar fascia has critical role in normal mechanical function of foot.[3]
The plantar fascia is a thickened fibrous aponeurosis that originates from the medial tubercle of the calcaneus and runs forward to form the longitudinal foot arch. The function of the plantar fascia is to provide static support of the longitudinal arch and dynamic shock absorption.[4]
Plantar fasciitis is an inflammation of plantar fascia. It is also known as plantar heel pain syndrome, heel spur syndrome or painful heel syndrome[5] Plantar fasciitis accounts for 10-15% of all foot conditions and it is the most common cause of heel pain.[6]
Some authors have reported that plantar fasciitis accounts for between 8% to 15% of foot complaints in non athletic and athletic population.[5,6,7] Sedentary population and runners are more prone to plantar heel pain. After
patellofemoral pain and iliotibial band friction syndrome, plantar fasciitis is third more common running injury. Americans annually affects as much as 10% of general population over the course of lifetime.[8]
There are various etilogical factors resulting in plantar fasciitis these are classified as biomechanical, environmental and anatomical. Among biomechanical explanations are abnormal joint mechanics, tight posterior musculature and resultant range of motion. Individuals with poor foot biomechanics that stress plantar fascia are commonly diagnosed with plantar fasciitis.[9]
Common causes/ risk factors of plantar fasciitis are: flat feet, weak foot arch, middle aged or older, long standing occupation ,overweight, wearing shoes with poor support, athletes. [7]
Plantar fasciitis pain is felt on the sole of foot at inferior region of heel and metatarsal heads . Pain is bad in morning with first step or extended refrain from weight bearing activity. Heel pain diminishes after few steps and through course of day but with prolong weight bearing activity pain is significant.[10]
Decreasing pain, promoting healing, restoring range of motion and strength correcting training, limiting biomechanical deviation caused by structural abnormalities and maximizing good nutrition is main focus of conservative treatment for plantar fasciitis.[11]
Ultrasound is a high frequency sound wave with an affinity for tendons and ligaments (highly organized, without high water content). Ultrasound heats these tissues and the tissues absorb the energy, resulting in an increase in tissue temperature and metabolism, tissue softening, and an increase in circulation. Ultrasound has also been purported to increase chemical activity in tissues, increase cell membrane permeability, deform molecular structures, and alter diffusion and protein synthesis rates, all potentially affecting the speed of tissue repair.[12]
The purpose of the night splints is to keep the ankle in neutral position mostly during the night. Night splints differ from the SPS brace in that they are
designed to place constant load on the tissues for an extended period of time using the creep concept.Splints worn at night keep the foot either in a neutral position or in 5º of dorsiflexion, which prevents chronic shortening of the fascia or the posterior leg muscles. Although the splints are frequently used for treatment of plantar fasciitis, most of the studies had high dropout rates and low compliance, possibly due to discomfort caused by the splint.[13]
Stretching and strengthening programs play an important role in the treatment of plantar fasciitis and can correct functional risk factors such as tightness of the gastrocsoleus complex and weakness of the intrinsic foot muscles. Increasing flexibility of the calf muscles is particularly important. Frequently used stretching techniques include wall stretches and curb or stair stretches.[14]
Evidence from study suggest that calf muscle stretching whether manually or with the aid of brace or splint can help alleviate plantar fascitis pain. What less clear however is which specific stretching method and protocol is most effective. [15]
There was no study done to find effectiveness using night splints and ultrasound so there is a need to compare the effectiveness of night splint versus ultrasound with active stretching in plantar fasciitis patient.
6.1 NEED OF THE STUDY:
Various studies in the past showed that night splinting approaches in treating plantar fasciitis was more effective than tendo achilles stretch, anti inflammatory medication and shoe recommendation.
Studies also suggest that strong supporting evidence from number of invitro studies and few human studies investigated invitro about positive effects of ultrasound on tendon healing.
No study has been conducted on plantar fasciitis using night splint and ultrasound in Indian population .Thus proposed study intends to find efficacy
of night splint versus ultrasound in plantar fasciitis on group of randomised targeted population.
6.2 OBJECTIVE OF THE STUDY:
A) OBJECTIVES
·  To investigate effectiveness of night splint and active stretch to reduce pain and improve functional abilities in patients with plantar fasciitis.
·  To investigate effectiveness of ultrasound and active stretch to reduce pain and improve functional abilities in patients with plantar fasciitis.
·  To investigate effectiveness night splints and active stretch versus ultrasound and active stretch to reduce pain and improve functional abilities in patients with plantar fasciitis.
B) HYPOTHESIS:
NULL HYPOTHESIS:
·  There will be no significant change in pain and function with night splints and active stretch in patients with plantar fasciitis.
·  There will be no significant change in pain and function with ultrasound and active stretch in patients with plantar fasciitis.
·  There will be no significant change in pain and function with night splint and active stretch compared with ultrasound and active stretch in patients with plantar fasciitis.
EXPERIMENTAL HYPOTHESIS:
·  There will be significant change in pain and function with night splint and active stretch in patients with plantar fasciitis.
·  There will be significant change in pain and function with ultrasound and active stretch patients with plantar fasciitis.
·  There will be significant change in pain and functions with night splint and active stretch compared to ultrasound and active stretch in patients with plantar fasciitis.
.6.2 REVIEW OF LITERATURE:
1) Radford et al. Confirms that there is limited effectiveness of some of the common conservative treatments, but suggests that calf muscle stretching, while improving ankle range of motion may reduce pain by reducing stress along plantar fascia. [16]
Clark et al also suggested that ultrasound may be used for its thermal effects in order to relieve pain and muscle spasm to increase tissue extensibility which may be of use in combination of stretching exercises to achieve optimal tissue length.[17]
2) Martin et al. Compared tension night splint with custom made orthosis which proved custom made orthosis were better in initial stage but later no significant difference was noted between two.[18]
3) Wapner and Sharkey found night splinting to be 100% successful in 11 out of 15 symptomatic patients in less than 4 months with no recurrence of symptoms at 9 month.[19]
4) Probe et al, found night splinting to be more effective in combination with tendo Achilles stretches, anti inflammatory medications and shoes recommendations when compared to same treatment without night splinting.[20]
5) Babcock et al. surmised that pain due to plantar fasciitis may be due to one of the following mechanisms: “irritation of pain fibers by repeated trauma or chronic pressure from a thickened plantar fascia, ischemic pain from chronic pressure of thickened fascia against digital vessels, enhanced effect of local pain neuro transmitters/ chemicals such as substance P and glutamate, and increased nociceptor sensitivity secondary to inflammation.”[21]
6) Dyck, 2004. Plantar fasciitis can also be known as heel pain syndrome and heel spur syndrome. This disorder affects the hind foot, specifically the insertion of the plantar aponeurosis at the medial cancaneal tubercle. The signs and symptoms associated with plantar fasciitis are produced by the excessive
load or tension to this area, which forms an anchor around the longitudinal arch of the foot .[22]
7) Greve et al. assessed the effectiveness of combined treatments, including stretching exercises and ultrasound or radial shockwave therapy. Their results suggested that combined treatment of ultrasound and stretching of gastrocnemius and plantar fascia being are as effective as radial shockwave therapy and stretching of the gastrocnemius and plantar fascia.[23]
8) DiGiovanni et al. 2003 administered non weight bearing plantar fasciitis stretching program for eight weeks, three times a day with ten repeatations. Significant improvements were seen in pain levels at eighth week, when examined with pain sub-scale of Foot Function Index. Over all superior results were obtained in the plantar fascia stretching group [24]
9) Dimou, Brantingham and Wood et al. compared custom orthotics to a regimen of chiropractic adjustments/manipulation of the foot and ankle along with a daily stretching regimen.The custom orthotics group reported significant improvements in almost all outcome measures, but these improvements were not statistically different or superior to those obtained in the chiropractic and stretching group.[25]
10) Beyzadeoglu et alstudied 44 patients with plantar fasciitis symptoms averaging 7.2 ± 5.9 weeks in duration.The authors reported greater short term improvement in pain and function in subjects who agreed to wear a night
splint in conjunction with standard conservative treatment of a silicone heel cushion, oral NSAIDs, stretching, exercise, and diet recommendation for overweight individuals, compared to the group who did not use the night splint.[26]
11) Powell et al. conducted a crossover prospective randomized outcome trial of dorsiflexion night splints on chronic plantar fasciitis patients who were unresponsive to previous conservative therapies. This trial used only night splints and no other interventions, thus truly testing the effect of the night splint alone. Use of the dorsiflexion night splint produced impressive relief for most patients, 88% reported some improvement, and the average improvement for those who noted improvement was 59%.[ 27]
12) Whiting M F et al : this sdudy was done to evaluate the use of ultrasound in the treatment of plantar fasciitis in optimum intensity 2-3W/cm2. There is a need for therapist to prove the efficacy of different dosages of ultra sound across therapeutic range considering different parameters. This study proved that,though there was a slightly greater mean improvement in heel pain in the treatment group,it was of no statistical significance.[ 28]
13) Katz, 1999 and Carlsson, 1983. In this study the client was instructed to keep detailed notes about activity levels during the day and specifically note on the VAS pain levels when first arising in the morning, time spent doing activities (specifically dancing) and pain levels after those activities. VAS is proved highly reliable and valid with reliability r= 0.71, P <0.001 and validity 0.71-0.78. [29]
14) Scott, 1976: The VAS is a scale used as a subjective measurement of pain experienced on a level between zero and 10 with zero being no pain and 10 being the worst. The VAS is a well-studied method for measuring both acute and chronic pain.[30]
15) Budiman – Mak E. , Conarad K.J.,and Roach , K.E : objective of study was to measure the impact of foot pathology on function in terms of
pain, disability, and activity restriction. This study showed that foot function index has good test- retest reliability and internal consistency of 0.87 and 0.96 respectively. Strong correlation between FFI total and subscale scores and clinical measures of foot pathology supported criterion validity of the index[31]
7) MATERIALS AND METHOD:
7.1 SOURCE OF DATA:
Patients with plantar fasciitis from hospitals and clinics in and around Bangalore.
A)  POPULATION:
Patient diagnosed with plantar fasciitis.
B)  SAMPLE SIZE:
30 subjects fulfilling inclusion criteria will be recruited from population given above and divided into two groups, 15 subjects in each group. Both male and female between age groups 20-60yrs will be included.
Group1: Experimental group – night splint and active stretching
Group 2: Control group – ultrasound and active stretching
MATERIALS USED FOR THE STUDY:
·  Assessment chart
·  Therapeutic ultrasound
·  Night splint
·  Chair
·  Pen/ pencil
·  Plinth
·  Pillow
7.2 METHOD OF COLLECTION OF DATA:
A) SAMPLING TECHNIQUES:
Simple random sampling
B) MEASURING TOOLS:
·  VAS for pain assessment.
·  Foot function index for functional assessment.
C)  METHODOLOGY:
I)  STUDY DESIGN :
Randomised experimental study.
II)  INCLUSION CRITERIA:
1.  Clinically diagnosed with plantar fasciitis by clinician.
2.  Pain felt maximally over metatarsal region of foot.
3.  Pain felt maximally over heel of foot.
4.  No history of heel pain at rest.
III)  EXCLUSION CRITERIA:
1.  Subjects with clinical disorder were therapeutic ultrasound is contraindicated such as infective conditions of foot, tumor, calcaneal fracture, metal implant around ankle.
2.  Subjects with clinical disorder like dermatitis.
3.  Subject with impaired circulation to lower extremities.
4.  Subjects with referred pain due to sciatica and other neurological disorders.