Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial
Phase: PHASE1
Conditions: Chronic Plantar Fasciitis
Sponsor: Wake Forest University Health Sciences

Official Title:  Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel 
Randomized Clinical Trial
NCT05868577
IRB Approval Date:  04/05/2024

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Study Title: Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: 
Protocol for a Parallel Randomized Clinical Trial 
Principal Investigator: Michael A. Jones, DPM, FACFAS 
Atrium Health Wake Forest Baptist 
Podiatry-Westchester 
1814 Westchester Drive, Suite 300 
High Point, NC 27262 
michjone@wakehealth.edu 
Sub-Investigators: David W. Robinson, MD; David R. Sinacore, PT, PhD, FAPTA; Dekarlos 
M. Dial, DPM, FACFAS; Kerry A. Danelson, PhD; Garrett S. Bullock, PT, DPT, DPhil
Sponsor or funding source: CTSI 
Background, Rationale and Context 
Plantar fasciitis is one of the most common causes of foot pain in adults.  Plantar fasciitis 
demonstrates a lifetime prevalence rate of 10% and accounts for 1 million provider visits in the 
United States annually (1).  In 2007, an estimated $284 million was spent on medical treatments 
for this condition (2).   
Briefly, from an anatomical perspective, the plantar fascia is not inert. This thick band of 
tissue (aponeurosis) on the underside of the foot comprises three bands (i.e., medial, central, 
and lateral) that connect the calcaneus to the toes, has intimate involvement with the Achilles 
tendon, and acts as both a dynamic shock absorber as well a secondary support structure of the 
arch (3).  As the toes extend during the stance phase of gait, the plantar fascia tightens, 
creating a windlass mechanism (4) that results in elevation of the foot arch, inversion of the 
hindfoot, and, consequently, external rotation of the leg. The plantar fascia is actually well 
innervated and together with the intrinsic foot musculature plays a critical role in both 
proprioception and stability, serves to stabilize the arch, and provides dynamic sensory and 
motor control to the foot (3). Thus, when the plantar fascia becomes irritated or unhealthy, this 
can have detrimental effects on an individual’s ability for both standing and walking, which for 
most is essential for living.  Unfortunately, the etiology of plantar fasciitis is still poorly 
understood despite numerous studies on this condition (5).   
Thought to have primarily a mechanical origin, plantar fasciitis and its development is 
multifactorial, but strongly associated in individuals with an increased BMI (7) and/or decreased 
ankle joint dorsiflexion (i.e. calf muscle tightness) (8). The diagnosis of plantar fasciitis is usually 
based on clinical criteria alone, with pain localized to the medial tubercle of the calcaneus (i.e. 
its origin or enthesis) considered pathognomonic and is the most widely reported clinical sign. 
Most patients with plantar fasciitis report plantar heel pain after standing up from bed in the 
morning and/or after they have been seated for a prolonged time. Typically, the heel pain 
improves somewhat with ambulation but could intensify by day’s end with prolonged walking or 
standing. Patients will oftentimes compensate with their gait to avoid placing direct pressure on 
the heel.  Imaging plays a limited role in routine clinical practice, though may be useful to rule 
out other causes of heel pain when in doubt (6).  As in other musculoskeletal disorders, plantar 
fasciitis has shown associations with increased levels of depression, stress, and anxiety and 
may have a significant negative impact on foot-specific and general health-related quality of life 
(9-10).  
In terms of management, conservative therapy (e.g. stretching and/or strengthening 
exercises, self-myofascial release, NSAIDs, taping, arch supports, supportive shoes, rest, 
immobilization, etc. to name a few) is still viewed as the mainstay of treatment (11).  

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Interestingly, evidence on long-term prognosis of plantar fasciitis appears equivocal and no one 
treatment is superior to the others.  Though most experts tout plantar fasciitis as a self-limiting 
condition (12), some chronic sufferers report continued issues with this disorder 5-15 years from 
initial onset of symptoms (13), contributing to further ambivalence associated with this disorder.  
Surgery, typically performed by partially cutting the plantar fascia at the heel, can be offered in 
recalcitrant cases as a last resort.  This invasive intervention is of course not without risks, 
including possible incomplete relief of symptoms (or, worse yet, more pain than before surgery), 
nerve damage, and permanent changes in foot shape (i.e. flat foot).  Moreover, plantar fasciitis 
surgery in the US can cost $10,000 or more (which varies by geography, surgeon’s fees, facility 
costs, and other services such as anesthesia and follow up care) (14).   
Lying within the conservative-surgical treatment spectrum for plantar fasciitis is local 
corticosteroid injection (CSI) therapy (15), a minimally invasive intervention that is relatively 
quick and easy for the clinician to perform in the outpatient clinical setting.  A targeted plantar 
fascia injection typically combines both corticosteroid (CSI) and a local anesthetic (LA) as the 
substance infused (i.e. injectate).  Administration of a CSI near the irritated plantar fascia has 
documented evidence of providing pain relief for up to 1 month only (16).  A randomized trial 
performed as far back as 1956 showed no statistical difference between CSI and placebo (i.e., 
saline) with 6-18 months of follow-up recorded (17).  Yet, to this day, a CSI is essentially the 
only immediate intervention that can be proffered in the outpatient clinic by providers that third-
party payers (at least in the United States) will compensate for.  In point of fact, 73% of 
surveyed orthopaedic surgeons preferred CSI to treat heel pain (18), yet its own preeminent foot 
association, the American Orthopaedic Foot and Ankle Society (14), advocates for its judicious 
use for fear of deleterious side effects, including fat pad atrophy (20) and possible rupture (21).  
The ambiguity surrounding corticosteroid injection as therapy is further substantiated from 
histopathologic studies involving plantar fasciitis (22-24), which failed to demonstrate any 
inflammatory process, calling into question the rationale on the use of corticosteroids altogether, 
which are used primarily for their potent anti-inflammatory effects (18).  Reasonably, the 
terminology plantar fasciitis is perhaps a misnomer given the degenerative (rather than 
inflammatory) findings uncovered (24), which some investigators refer to as plantar fasciosis or 
plantar fasciopathy, given the similar tissue pathology seen in other musculoskeletal tendon 
disorders, or tendinopathies (25-28, 31).   
While there have been several prospective investigative studies on CSI for plantar 
fasciitis, there is vagueness on injection method.  There are essentially two described 
techniques (29): single injection (how CSI is traditionally administered) or peppering injection, 
the latter initially described in 1964 (30) as a technique for lateral epicondylitis, a form of chronic 
tendinopathy involving the arm.  Injection peppering is thought to disrupt the chronic 
degenerative process by provoking bleeding and inflammation to promote healing (31).  Several 
study trials involving the injection method for lateral epicondylitis highlights that it is the physical 
needling of the pathologic site (i.e. peppering) as opposed to the injectate that incites healing 
(30-34).  Thus, a peppering injection performed for plantar fasciitis, though just hypothetical, 
would act similarly via repeatedly fenestrating the pathologic site and opening holes on several 
spots rather than a single spot (33) to stimulate hematoma formation and subsequent healing. 
To our knowledge, only two previous investigative studies have disclosed its use for plantar 
fasciitis (35, 36).  Likewise, the medical evidence on injection therapy for plantar fasciitis also 
shows imprecision on both the approach (i.e. medial or plantar heel) and target (i.e. superficial 
to, deep to, or into the plantar fascia) to inject, just as long as it is deposited close to the plantar 
fascia origin (enthesis) (19, 25, 37-39).   Though ultrasound guidance can provide more real-
time accuracy of where the injectate infiltrates, it shows no superiority to traditional palpation 
guided injection therapy (36). 
Our research team considers corticosteroid injection a nebulous and insufficient 
treatment option for plantar fasciitis sufferers.   If first do no harm is the physician’s axiom, then 

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CSI’s continued utilization altogether for this tricky pathology should be questioned.  Our 
investigative team has exposed a knowledge gap and posits a challenge to the existing CSI 
treatment paradigm for plantar fasciitis via an alternative minimally invasive infracalcaneal 
peppering injection technique being non-inferior to traditional CSI, with the premise that it is the 
needle rather than the steroid administered that is beneficial for the patient. 
Successful completion of our proposed pilot study addresses a critical knowledge gap in 
the treatment of chronic plantar fasciitis and breaches the translational roadblock of clinical 
implementation.  The results from this rigorous pilot study will provide the framework for our 
anticipated full-scale efficacy trial with the potential of affording the clinician an upgraded 
evidenced-based treatment option that has been demonstrated to be safe, effective, and 
reproducible.   
 
Objectives 
 
1. Assess feasibility of infracalcaneal peppering injection technique with and without CSI in 
the management of patients with chronic plantar fasciitis. 
a. Feasibility of recruitment, randomization, retention, patient and physician time 
constraints, and tolerability of treatment will be assessed.  Clear quantitative 
benchmarks and a number needed to treat will be achieved for planned utilization 
in a subsequent full-scale efficacy trial.   
2. Assess the efficacy of infracalcaneal peppering injection with and without CSI for 
reduction in pain utilizing two validated patient reported outcomes measures (PROMs): 
the Visual Analog Scale (VAS) and Foot Function Index (FFI), administered at baseline, 
then at 2, 4, 8, and 12 weeks.  Minimal Important Difference (MID) calculations for both 
VAS and FFI PROMs, specifically for plantar fasciitis, have already been 
investigated/established and will be used as a reference. 
a. Greater than 75% of these PROMs from ALL cumulative target dates will be 
captured, providing a target number needed to treat (NNT) to conduct a full-scale 
efficacy trial investigation. 
 
Methods and Measures 
 
Design: A randomized, double-blind placebo-controlled pilot study at one single 
institution 
 
Setting: Atrium Health Wake Forest Baptist Department of Orthopaedic Surgery-
Podiatry Services practice located in High Point, North Carolina  
 
Subject Selection Criteria 
 
Inclusion Criteria 
• 
Men and women 18 years of age and older 
• 
Patient reported history of plantar heel pain and confirmed clinical tenderness of pain 
with direct palpation of the medial calcaneal tubercle on baseline exam 
• 
Diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms 
greater than or equal to 6 weeks in duration 
 
Exclusion Criteria 
• 
Individuals less than 18 years of age 
• 
Pregnancy 

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• 
History of receiving a local heel injection (i.e. CSI or other injectate) within the last 3 
months  
• 
Prior heel trauma or surgery 
• 
Allergy to local corticosteroid or local anesthesia  
 
Sample Size 
 
We estimate the sample size required to answer the research question to be 50 participants. 
 
Interventions and Interactions 
 
Once both informed consent and enrollment have been verified, initial evaluation by the PI will 
be conducted on participants, and baseline assessments will be performed. The assessments 
include: 
• 
Documentation of participant age at enrollment along with information on sex/gender, 
race, and ethnicity to ensure the study involves Inclusion of Individuals across the 
Lifespan 
• 
History and physical exam 
• 
Calculated BMI 
• 
Documentation of referral patterns (PCP, self, or other referral)   
o If from PCP or other, documentation of what information/work-up was 
provided (e.g. told they have “heel spur”, given NSAIDs, exercises, etc.) 
• 
Clinical confirmation/diagnosis of plantar fasciitis (pain at medial calcaneal tubercle) 
• 
Dolorimeter readings of PPT # (pressure algometer) 
• 
Documentation of subjective reporting of first-step pain (yes/no) 
• 
Foot posture score 
• 
Heel tenderness score 
• 
Initial X-ray (notation and measurement of heel spur) of the symptomatic foot/heel 
will be performed, if not already completed 
• 
Initial diagnostic musculoskeletal US (PF thickness and echogenicity; fat pad 
thickness)  
• 
Patient completed baseline self-assessment of both “general heel pain” and “first 
step pain” (VAS PROM) 
• 
Patient completed baseline self-assessment of foot function (FFI PROM) 
  
At this point, the patient will be block allocated to their study arm, having been randomized in a 
double-blind fashion by the clinical coordinator. This individual will facilitate safe record-keeping 
and the processes required to maintain the double-blind design of this study. We will specifically 
conduct the study in a permuted block design to ensure a 1:1 ratio for the two treatment 
intervention groups. The study arms are as follows: 
• 
Group 1 - CSI/LA injection 
• 
Group 2 - LA/Saline injection 
 
A nurse or staff member will open a previously prepared and sealed opaque envelope (prepared 
beforehand by the clinical coordinator) labeled with the participant ID of the patient, which will 
be unique to the individual and different from their MRN. In this envelope, they will discover the 
patient’s assigned treatment arm. The nurse or staff member will then prepare the syringe with 
the assigned treatment arm. Once the syringe is filled with the designated substance, the 
syringe will be wrapped with opaque tape or dark Coban wrap to conceal the contents in the 

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syringe for both the PI and study participant. The participant’s skin will be sterilely prepped with 
alcohol. 
  
The PI will then administer the injection using an infracalcaneal needle peppering technique as 
follows: 
1. The hypodermic needle is inserted using infracalcaneal injection approach. 
2. The hypodermic needle is withdrawn while at the same depositing injectate. 
3. The hypodermic needle is redirected without emerging from the skin. 
  
The PI will perform steps 1-3 standardly 20-25 times. Following the completion of the injection 
and clinical observation, the patient will receive home care and follow-up instructions which will 
include the standardized teaching of 3 exercises (calf stretching, plantar fascia specific 
stretching, and plantar fascia loading exercise). Patients will be sent home with an exercise 
diary to record when and if they complete the instructed exercises with directions to bring the 
diary to the next visit. Patients will receive 1 phone call between this visit and the next to check 
in on their exercise progress and remind them to complete the exercise diary. 
  
The patient will be seen at follow-up visit #1 for evaluation and management 2 weeks post-
treatment intervention. At this visit, the following assessments will be completed: 
• 
History and physical exam 
• 
Patient self-assessment of both “general heel pain” and “first step pain” (VAS PROM) 
• 
Patient self-assessment of foot function (FFI PROM) 
• 
Dolorimeter readings of PPT # (pressure algometer) 
• 
Heel tenderness score 
• 
Review of the exercise diary 
A new exercise diary will be given to the patient. The recommended exercises will be instructed 
again. Patients will be encouraged to bring the diary to their next visit. To increase compliance, 
patients will receive 1 phone call to check in on their exercise progress and remind them to 
complete the exercise diary. 
 
The patient will return for follow-up visit #2 for evaluation and management 4 weeks post-
treatment intervention. At this visit, the following assessments will be completed: 
• 
History and physical exam 
• 
Patient self-assessment of both “general heel pain” and “first step pain” (VAS PROM) 
• 
Patient self-assessment of foot function (FFI PROM) 
• 
Dolorimeter readings of PPT # (pressure algometer) 
• 
Heel tenderness score 
• 
Review of the exercise diary 
A new exercise diary will be given to the patient. The recommended exercises will be instructed 
again. Patients will be encouraged to bring the diary to their next visit. The patient will be called 
1 time to remind them to complete their exercise diary between visits. 
 
The patient will return for follow-up visit #3 for evaluation and management 8 weeks post-
treatment intervention. At this visit, the following assessments will be completed: 
• 
History and physical exam 
• 
Patient self-assessment of both “general heel pain” and “first step pain” (VAS PROM) 
• 
Patient self-assessment of foot function (FFI PROM) 
• 
Dolorimeter readings of PPT # (pressure algometer) 
• 
Heel tenderness score 

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• 
Review of the exercise diary 
A new exercise diary will be given to the patient. The recommended exercises will be instructed 
again. Patients will be encouraged to bring the diary to their next visit. The patient will be called 
1 last time to remind them of their exercise diary and encourage them to complete it.  
 
The follow-up visit #4 will be the final study visit. This visit will occur 12 weeks post-treatment 
intervention. At this visit, the following assessments will be completed: 
• 
History and physical exam 
• 
Patient self-assessment of both “general heel pain” and “first step pain” (VAS PROM) 
• 
Patient self-assessment of foot function (FFI PROM) 
• 
Dolorimeter readings of PPT # (pressure algometer) 
• 
Heel tenderness score 
• 
Review of the exercise diary 
• 
Final diagnostic musculoskeletal US (PF thickness and echogenicity; fat pad thickness)  
• 
Exit survey 
 
Evaluation Schedule Summary 
 
Procedures 
Screening Injection Week 2 Week 4 Week 8 Week 12  
-42 to -1 
days 
day 0 
+/- 3 
days 
+/- 3 
days 
+/- 3 
days 
+/- 3 days  
Review Study Procedures, 
Informed Consent, and Privacy 
Authorization 
x 
x 
 
 
 
 
 
Eligibility Criteria for Study 
Entry 
x 
x 
 
 
 
 
 
Patient Demographics 
x 
 
 
 
 
 
 
Patient Medical/Surgical 
History 
x 
x 
 
 
 
 
 
Height, Weight, and Vital Signs 
x 
x 
x 
x 
x 
x 
 
Foot & Ankle Physical Exam 
x 
x 
x 
x 
x 
x 
 
Presentation of Exercise 
Therapy (targeted stretching 
and strengthening) 
x 
x 
x 
x 
x 
x 
 
Clinical Observation 
x 
 
 
 
 
 
 
X-ray of Affected Foot 
x 
 
 
 
 
 
 
Ultrasound of Affected Foot 
x 
 
 
 
 
x 
 
Randomization  
 
x 
 
 
 
 
 
Study Therapeutic Treatment 
Intervention (infracalcaneal 
needle peppering injections) 
 
x 
 
 
 
 
 
Evaluation of Injection Site 
 
x 
x 
x 
x 
x 
 

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Subject Self-Assessments         
- VAS PROM (for both general 
heel pain and first step pain)     
- FFI PROM  
x 
x 
x 
x 
x 
x 
 
Exercise Diary & Instruction of 
the 3 Exercises  
 
x 
x 
x 
x 
x 
 
Foot Posture 
x 
x 
 
 
 
 
 
Heel Pressure Threshold using 
Dolorimeter 
x 
x 
x 
x 
x 
x 
 
Heel Tenderness Score 
x 
x 
x 
x 
x 
x 
 
Exit Survey 
 
 
 
 
 
x 
 
*Not on schedule: reminder phone call between study visits to encourage exercise diary 
completion and compliance. 
 
Outcome Measure(s) 
 
Patient Assessments 
• 
Heel Tenderness VAS PROM  
• 
First Step Pain VAS PROM 
• 
FFI PROM 
• 
Exercise Diary 
• 
Exit Survey at completion of study 
 
Physician Assessments 
• 
Baseline and subsequent foot and ankle physical exam, heel pressure threshold, and 
heel tenderness score 
• 
X-ray and ultrasound imaging 
o Our research team will be the first to examine musculoskeletal ultrasound 
imaging obtained both before and after an infracalcaneal peppering injection in 
participants with chronic plantar fasciitis. Musculoskeletal ultrasound has become 
more established in the medical literature as a reliable objective measure of 
plantar fasciitis, with thickness measurements >4.0mm correlating with clinical 
symptoms (40). Musculoskeletal ultrasound's utility here would enable our 
investigators to assess for any quantifiable tissue changes associated with our 
intervention. 
 
Patient Retention 
 
Every effort will be made to retain patients in the study to ensure complete data collection. 
During the study consent process, potential study participants will be educated regarding the 
importance of full participation in all visits. Patients will be reminded of their upcoming 
appointment via phone call or email. Patients will also be reminded about their follow-up visits at 
all clinic visits. 
 
Patient/study participant compensation will occur at certain study visits. Study participants will 
receive a paid total of $100.00 if all scheduled study visits are completed. 
 

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Study Visit #1 – injection day 
$20.00 
Study Visit #2 – 2 weeks post-treatment 
intervention 
No payment. Next payment at 4-week follow-
up study visit (visit #3). 
Study Visit #3 – 4 weeks post-treatment  
intervention 
$40.00 
Study Visit #4 – 8 weeks post-treatment 
intervention 
No payment. Next payment at 12-week 
follow-up study visit (visit #5).   
Study Visit #5 – 12 weeks post-treatment 
intervention 
$40.00 
 
Analytical Plan 
 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will be 
done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous 
variables.  Regression analysis will be performed to identify independent outcome predictors.  
Other inferential statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for 
inclusion into the study. The study will be conducted in accordance with the current IRB-
approved clinical protocol; ICH GCP Guidelines adopted by the FDA; relevant policies, 
requirements, and regulations of the clinical test site IRB; and applicable federal agencies.  
 
Patients who meet the inclusion criteria will be asked to participate in the research study and 
provided ample time and encouragement to ask questions and discuss the study with others 
(medical providers, family, friends, etc.). A copy of the informed consent form will be provided to 
the patient. The study team will answer all questions. 
 
Subjects may withdraw from the study at any time for any reason at their request. Otherwise, 
participants will be followed as per the protocol. Attempts will be made to collect clinical data 
from withdrawn subjects. There will be no replacement of subjects who withdraw from the study. 
 
Subject Recruitment Methods 
 
The study will recruit patients who present to the Atrium Health Wake Forest Baptist Department 
of Orthopaedic Surgery-Podiatry Services practice located in High Point, North Carolina with 
symptoms of plantar heel pain. In order to approach patients that have received care at this 
practice in the past, we will create an i2b2 query to result a list of patients seen by Dr. Jones 
and diagnosed with plantar fasciitis within the last 3 years (11/1/2020 – 11/1/2023). These 
patients will be contacted by the study coordinator to introduce the study, gauge their interest, 
and begin the pre-screening process if they opt in to doing so.  
 
Additionally, the study will be listed on Be Involved and study flyers will be distributed and 
posted. A social media ad will also be distributed on Facebook and Instagram with information 
about the study and a link to the Be Involved web page. Interested potential subjects will be 
contacted via telephone or email and be asked to complete a pre-screening questionnaire. We 
will utilize a REDCap survey in instances where the potential subject prefers email 
communication to conduct the pre-screening questionnaire. Study flyers will have a QR code 

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available for interested individuals to scan and easily access the REDCap pre-screening 
questionnaire. 
 
All completed questionnaires and personal identifying information collected via Be Involved, 
both for recruited subjects and those who have declined participation, will be kept securely by 
the select study personnel. This information will remain in a password protected file and only be 
accessed on a secure network. 
  
 
Study Screening and Enrollment 
 
Potential study participants will be screened in the Orthopaedic Surgery-Podiatry Services 
Practice. Patients with plantar heel pain who meet the study inclusion criteria will be told about 
the study and will be asked if they would like to participate. The study will be described, and the 
requirements for study participation will be explained. Potential study participants will be 
encouraged to ask questions about the study and to find out what is involved in study 
participation. Patients who agree to participate will be asked to provide informed consent. No 
study related procedures will occur until after the informed consent is obtained. Following 
completion of informed consent, the study procedures will begin. 
 
Informed Consent 
 
Signed informed consent will be obtained from each subject in the privacy of a closed clinical 
examination room. A study team member will discuss the study with patients who meet study 
entry criteria and will obtain consent while the patients are in the clinic following their visit. Each 
study participant will receive a copy of the signed informed consent form. 
 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, fully minimizing the collection of any information that could directly identify subjects 
and maintaining all study information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form. Any 
collected patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file and stored separately from the data. The linkage file will be kept 
secure, with access limited to designated study personnel. Following data collection, subject 
identifying information will be destroyed six years after closure of the study by shredding any 
paper documents and deleting information from computer files, consistent with data validation 
and study design, producing an anonymous analytical data set. Data access will be limited to 
study staff. Data and records will be kept locked and secured, with computer data being 
password protected. No reference to any individual participant will appear in reports, 
presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants. The principal investigator will be assisted by other members of the study 
staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 

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Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
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Appendix 
1. Data Collection Sheet 
2. VAS PROM 
3. FFI PROM 
4. Exercise Diary 
5. Exit Survey