Hamstring injury evaluation treatment

THE EFFECT OF ELECTRICAL INTRAMUSCULAR STIMULATION

ON SUB ACUTE AND CHRONIC MUSCLE STRAIN INJURIES

Principal Investigator:      Dr. Jack Taunton, MSc , MD , Dip Sport Med

Professor of Exercise Science, School of Human Kinetics Director of Allan McGavin Sports Medicine Clinic, University of British Columbia

604-822-3614

Co-Investigators:                 Dr. N.Yelizarov

160-3920 Francis Rd

Muscle & Tendon Strain Injury Clinic

 604-818-3462

FREQUENTLY ASKED QUESTIONS:

1. Who can participate in the study?

2. Who can't participate in the study?

3. What are the benefits of participating?

4. What does the study involve?

5 . What is the purpose of the study?

6. Who is conducting the study?

1. INTRODUCTION-“The invitation to participate”

The research is focused on muscle strain injuries. A hamstring injury is chosen as one of most frequent injury among sport athletes.

You are being invited to take part in this research study because you are a male or female found to be suffering a Hamstring Injury with the same age and activity level as another participant suffering from a hamstring injury.

2. YOUR PARTICIPATION IS VOLUNTARY

Involvement in this research study is entirely up to you, so it is up to you to decide whether or not to participate. Before you decide, you must understand what this study involves. This consent form will explain to you why the research is of importance, what procedures will be carried out during the study, and possible benefits, risks, and discomforts.

If you decide to participate, you will be asked to sign this form. If you do decide to take part in this study, you are still free to withdraw at any point and without giving any reason to your decision.

If you do not wish to participate, you do not have to provide any reasoning for your decision, nor will you lose the benefit of any medical care to which you are entitled or are presently receiving.

Please take time to read over the following information carefully and discuss it with your family, friends, and doctor before you decide.

3. WHO IS CONDUCTING THE STUDY?

The study is being conducted by Primary Care Physician, Acupuncturist and Physiotherapist at Allan McGavin Sports Medicine Clinic and Muscle & Tendon Strain Injury Clinic. (top)

4. BACKGROUND

Hamstring Injury is a condition currently accounting for 41% of all lower extremity injuries in sport active population, and studies are showing a trend of increasing prevalence.

This irritation and subsequent pain in the hamstring muscles area is associated with overuse and repetition of the injury. However, the incidence of injury is also related to not efficient enough treatment of previous injury. Therefore an effective treatment option will not only treat a recent injury but help to prevent the reoccurrence of another injuries.

Typical treatment of Hamstring Injuries involves rest, ice, compression, physiotherapy treatment   and a gradual introduction to an eccentric strengthening program of the hamstring muscles. The treatment focuses on the injured area alone, and not on the associated factors or biomechanical deficits related to the injury. Without an early diagnosis, and effective treatment, clinical resolution of Hamstring Injuries may well be longer than three months. More chronic Hamstring Injury cases may require an intense rehabilitation program of up to six months.

The best way to treat Hamstring Injuries remains unclear.

5. WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this research study is to aid rehabilitation professionals to establish a more effective therapy option, which will be able to focus not only on the Hamstring Injury, but any muscle strain injury related to work, sport or accident. The particular study is designed to collect data and observe possible difference between three treatment groups.  One of main hypothesis is that the role of an inflammation in subacute and chronic muscle strain injuries may not be as significant as it generally accepted.

Group F0 is group with subjects under subsensory electrical intramuscular stimulation.

Group FH is group with subjects under high frequency electrical intramuscular stimulation.

Group FL is group of subjects under low frequency electrical intramuscular stimulation. (top)

6. WHO CAN PARTICIPATE IN THIS STUDY?

You are invited to participate as a subject in this study if you are a person, found to be suffering from Hamstring Injury not less than 3 weeks ago and not more than 6 months ago. If Injury occurred previously, this must have been at least one year ago. Age of participant: 19 – 54 years old.(top)

7. WHO SHOULD NOT PARTICIPATE IN THE STUDY?

Hamstring Injury patients who

       - experienced muscle strain injury symptoms in less than 1 month or more than 6 months,

 
  - taking medication such as analgesics, NSAID, muscle relaxants during the trial.

 - have bleeding or autoimmune disorders 
 

Subjects who have had previous Hamstring Injury /surgeries/pain should not participate in this study.

In addition, you should not participate in this study if you have for any reason the inability to carry out an acupuncture needle insertion on your affected leg.(top)

8. WHAT DOES THE STUDY INVOLVE?

Location: This study is taking place at Allan McGavin Sports Medicine Clinic University of British Columbia, in Vancouver , Canada . It is anticipated that 54 subjects will be enrolled in the study with electrical intramuscular stimulation treatment. Subjects will be form 3 groups with 18 individuals in each group.

Prior to the study: On your first visit to the Sports Medicine Centre a medical history (time frame of symptoms) and a physical examination will be collected. There are no blood tests during this exam. You will be asked to complete a questionnaire and to evaluate your pain level in the beginning and end of the trial. You will be randomly assigned (“like a flip of a coin”) to one of the three treatment groups. This means you have equal chance to be placed in any of the treatment groups.(top)

EXPERIMENTAL PROCEDURE:

If You Decide to Join This Study: Specific Procedures

If you agree to take part in this study, the procedures and visits you can expect will include the following:

Before any procedure is carried out, the researcher will measure your muscle strength of hamstring muscle with an instrument for measuring the degree of muscular power called dynamometer and will record both your age and an estimate of your activity level.

Three groups (n=18) subjects treated with use of electrical stimulation with 3 different frequency mode and two acupuncture needles.

During the electrical intramuscular stimulation treatment, subjects lay on a massage table. Needles are inserted in strategically chosen spots of the target-muscle (not a trigger points) and wires are securely connected to needles by “alligators” in order to achieve good contact. After the wires are in place the thirty minute treatment commences. If the pain source is localized in a single muscle only the treatment may be shorter, because the single muscle injury requires 5-7 minutes of treatment per session. The acupuncturist will be blinded on electrical frequency choice. The assistant will choose what frequency to employ regarding the belonging to the group and treatment protocol.

All groups are subjectively tested for pain and muscle strength with BioDex dynamometer  before the first session and in the end of the study.

Statistics: The peak value from these trials will be recorded and applied to the following formula to calculate dimensionless torque:

% (BW x h) = Torque (N x m) x 100/BW(N) x h(m)

The affected muscle(s) strength will be measured twice:before the study and in the end of the study.  This difference in measurements results will support or reject the study hypothesis.

These experimental procedures are beyond 'normal care', and are not normally done in routine clinical care for Hamstring Injury.

OVERALL DURATION OF THE STUDY

All subjects will be seen at the Muscle & Tendon Strain Injury Clinic 3 times every week for 10 session total. Every visit will take 30 min. In these visits you will be asked to fill out a discomfort questionnaire and the Primary Care Physician will do a history and examine your affected muscle. Visits will take approximately total 600 min of your time in the study

9. WHAT ARE MY RESPONSIBILITES?

In order to participate, you must let the investigators know all treatment recommendations given to you to treat your Hamstring Injury, and any exercises or therapies carried out to treat your injury.

You should follow recommendations of trial practitioner regarding the sport activity level and stop using any pain killers, muscle relaxants or anti inflammatory medication

10. WHAT ARE THE POSSIBLE HARMS AND SIDE EFFECTS OF PARTICIPATING?

Side effects of electrical intramuscular stimulation may include, but are not limited to:

-    Bruise from needling a blood vessel. Usually it is temporary cosmetic damage only because applied finger pressure for a few minutes is sufficient to stop bleeding.

-    Muscle soreness on the next day after the first session of Electrical Intramuscular Stimulation. The muscle soreness is similar to sensations of DOMS and usually disappears in 24-48 hours.

-    A recipient may faint if the fear of needles is severe. Proper recipient screening will help to recruit right volunteers. If faintness occurs, a lying position with the legs elevated will solve the problem.

-    A nerve needling may cause some severe pain for a part of second due nerve branch needling. The needle will be removed immediately if it occurs. No treatment is required because some techniques even recommend this for quicker improvement.

There is also a small risk of infection (needles are single use only) and may be feeling of lightheadedness for up to 5-15 min.

11. WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY?

Personal Benefit: No one can guarantee that you will benefit from this study. The study will test 3 types of treatment and their effectiveness. At the end of the study we will provide the most effective treatment method free of charge to the volunteers who have participated in the study. We hope that the information regarding possible associations and/or causes of this injury learned from this study can be used in the future to benefit other people with a similar injury. If you wish, we can provide you with the results from this study after it is completed.

Societal Benefit: A long-term benefit arising from this study is that it may provide a treatment option for any muscle strain injury. This may in turn may lead to an improvement in rehabilitation techniques through the establishment of a more appropriate and effective therapy treatment plan.(top)

12. WHAT ARE THE ALTERNATIVES TO THE STUDY TREATMENT?

The trial involves improvement of hamstring muscles strength, and does qualify as a 'treatment'.

. You can discuss you options with your doctor before deciding whether or not to participate in this research project.

13. WHAT IF NEW INFORMATION BECOMES AVAILABLE THAT MAY AFFECT MY DECISION TO PARTICIPATE?

If new information arises during the study that may affect your willingness to remain in the study, you will be advised of it. Such a situation would arise if risks were identified in relation to your participation in this study.

13. WHAT HAPPENS IF I DECIDE TO WITHDRAW MY CONSENT TO  PARTICIPATE?

Your participation in this research is entirely voluntary. You may stop participating in the study at any time. If you decide to enter the study and to withdraw at any time in the future, there will be no penalty or loss of benefits to which you are otherwise entitled, and your future medical care will not be affected.

The study investigators may decide to discontinue the study at any time, or withdraw you from the study at any time, if they feel that it is in your best interests.

If you choose to enter the study and then decide to withdraw at a later time, all data collected about you during your enrollment in the study will be retained for analysis. By law, this data cannot be destroyed.

15. WHAT HAPPENS IF SOMETHING GOES WRONG?

You do not waive any of your legal rights by signing this consent form.

16. CAN I BE ASKED TO LEAVE THE STUDY?

If you are not complying with the requirements of the study or for any other reason, the study investigator may withdraw you from the study. On receiving new information about the treatment, your research investigator might consider it to be in your best interests to withdraw you from the study without your consent if they judge that it would be better for your health.

17. AFTER THE STUDY IS FINISHED

Study results are likely to be available in May 2007. If desired, you can be informed of them by contacting an investigator.

18. WHAT WILL THE STUDY COST ME?

You will not incur any personal expenses as a result of participation, nor will you receive payment for participation.

19. WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?

Your confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, research records identifying you may be inspected in the presence of the investigator by the UBC Research Ethics Board for the purpose of monitoring the research. However, no records that identify you by name or initials will be allowed to leave the Investigators' offices.

20. WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY DURING MY PARTICIPATION?

If you have any questions or desire further information about this study before or during participation, you can contact Dr. Jack Taunton at (604) 822-3614 or Dr. Nikolay Yelizarov at (604) 818-3462.

21. WHO DO I CONTACT IF I HAVE ANY QUESTIONS OR CONCERNS ABOUT MY RIGHTS AS A SUBJECT DURING THE STUDY?

If you have any concerns about your rights as a research subject an/or your experiences while participating in this study, contact the 'Research Subject Information Line in the University of British Columbia Office of Research Services' at 604-822-8598.