Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting

All of the below items are research-related unless marked as 'standard of care':

Screening Visit:

- Obtain and document signed Informed Consent document and HIPAA Authorization.

- Review past medical history in Armed Forces Health Longitudinal Technology Application
(AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital
signs review, medication list, co-morbidities, demographics, and problems list.

- Record: Date of birth, age, gender, race, ethnicity, DOD ID#, name of standard of care
medications (over-the-counter and prescription), current email address (to be used for
scheduling), height (in inches), weight (in pounds), tobacco-use status, duration of
current shin splints, history of shin splints, and note any prior acupuncture received.

- Investigators will ask what the subjects expectations are regarding acupuncture's
effectiveness for medial tibial stress syndrome.

- If the subject is an active duty member, investigators will ask:

- Have you or are you currently on a fitness restriction for medial tibial stress
syndrome.

- If so, what are the dates of the restriction?

- There are several standard of care treatments and physical therapy options for the
treatment of medial tibial stress syndrome which include physical therapy and a home
exercise program. Investigators will standardize what patients in this study are
receiving by having all subjects follow the standard of care prescribed home exercise
program and discontinue any formal physical therapy when entering this study (regular
physical activity such as exercise is allowed, as tolerated by pain level).

Randomization: Subjects will be randomized into 1 of 2 equal groups, using a random number
generator:

- Group 1: Acupuncture plus the prescribed home exercise program

- Group 2: The prescribed home exercise program alone

Encounter 1--Day 1 (may be same day as screening visit):

- Subjects will be given a study diary to document the number of times they performed the
standard of care prescribed home exercise program. Subjects will be advised to complete
the stretching exercises daily and the strengthening exercises every other day.

- Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)

- Research treatment intervention according to their randomization group:

- Group 1:

Acupuncturist will be given a copy of the Protocol for Needle Insertion. Acupuncture will be
performed. The name of the physician performing the acupuncture and also the number of
acupuncture needles placed for each treatment.

The prescribed home exercise program will be reviewed. o Group 2: The prescribed home
exercise program will be reviewed.

- Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

- Administer the Pain Disability Index (PDI), Medial Tibial Stress Syndrome Score (MTSS
Score) electronically

- Subjects will be instructed to perform the stretching exercises daily and the
strengthening exercises every other day.

Encounter 2-- Week 2 Survey:

• Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
home exercise program diary

Encounter 3-- Week 4 Survey:

- Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
home exercise program diary.

- Subjects in the non-acupuncture treatment group, with failure of pain scale to decrease
by 2 points on 0-10 point pain scale, will be given the option to crossover to the
acupuncture treatment group, receive acupuncture, and continue scheduled follow-up at 2,
4, and 12 weeks.

Encounter 4-- Week 12 Survey:

- Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
home exercise program diary

- Investigators will ask if the subject's expectations regarding acupuncture's
effectiveness for medial tibial stress syndrome were met.

Acupuncture: For purposes of this study, acupuncture will be considered a research-related
intervention and all acupuncturists performing the procedure will be considered engaged
investigators for research purposes. For this study, all physician acupuncturists are deemed
engaged research investigators, since the acupuncture procedure is research-related for the
study. Unless the acupuncturist is added to the study, they will not be permitted to perform
the acupuncture procedure s on the research subjects. Acupuncture treatments will be
utilizing the KB-2 points with manual manipulation accomplished by vigorously running the
acupuncturists thumb nail up and down the handle until a perceived sensation change is noted
in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into
the upper third of the medial tibiofibular ligament, followed by a second needle
approximately 2-4 cm below the second needle. The needles will be manipulated as detailed
above to achieve the sensation change along the posteromedial tibia. The needles will then be
irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the
treatment is complete, which will last approximately 5-10 minutes (standard care).

Acupuncture treatments will be as defined: KB-2 are generally not defined specific points,
but are referred to the placement of the needle into the lateral leg and advanced through the
medial tibiofibular ligament (interosseous membrane). The initial KB-2 point will be placed
in the upper 1/3 of the leg distal to the tibial tuberosity. The second needle will be placed
2-4 cm below the first needle, still within the upper 1/3 of the leg.

This study will follow all FDA requirements for the safe use of these devices.

The acupuncture being performed in this study is a standard acupuncture technique for the
treatment of medial tibial stress syndrome. However, for this study, the research-related
acupuncture procedure being performed is considered research-related. The physicians
performing the treatment are trained in this acupuncture technique and added to the study as
engaged research investigators. The Food and Drug Administration (FDA) regulates acupuncture
needles as a class II medical device, because they are intended for use in the cure,
mitigation, treatment, or prevention of disease in man or are intended to affect the
structure or function of the body of man. The FDA regulates the acupuncture needles (see 21
CFR 880.5580). The needles being used are Hwato 0.30X100mm Acupuncture needles, which are
exempt from premarket notification by the FDA for use in acupuncture and will be used in
accordance with their FDA approved labeling.

***THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY
INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.***

Inclusion Criteria:

- Male and female DoD beneficiaries, age 18 years or older,

- Diagnosed with medial tibial stress syndrome (in one or both of their lower
extremities) OR subjects meeting criteria of pain in the posteromedial tibia with
exercise and direct palpation of the posteromedial tibia. Subjects with acute and
chronic diagnoses will be included.

Exclusion Criteria:

- Pregnant

- Any of the following in the lower extremity being included into the study:

- Active cellulitis of lower extremity

- Tibial stress fracture

- If they have ever had any prior acupuncture for medial tibial stress syndrome using
the defined KB-2 points.

- Use of anticoagulants

- Neurologic deficits, to include abnormal sensation, hypo- or hyper-active reflexes,
muscle weakness not attributable to pain

- History of needle-shock with acupuncture