Aim of this study is to determine the effectiveness of Extracorporeal Shockwave Therapy (ESWT) on degree of recovery after 3 months in patients with MTSS.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
bewegingsapparaat, bot
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is degree of recovery after 3 months (using a 5 point
Likert scale). The participants will complete a questionnaire at 4 time points
during the total study period of 29 weeks.
Secondary outcome
Parameters to determine the secondary outcome objectives in this study are:
- Experience of pain in sport activities, activities in daily
life/profession/education (using a numeric rating scale)
- Degree of restrictions in sport activities, activities in daily
life/profession/education (using a 5 point Likert scale)
- Response rates to questionnaires, and adherence/compliance rates,
- Satisfaction of ESWT
- Side effects of ESWT
Background summary
Medial tibial stress syndrome (MTSS) is one of the most common exercise-induced
overuse injuries in runners as well as athletes participating in jumping
sports, such as volleyball and basketball.(1) It can be quite disabling and
progress to more serious complications if not treated properly.(1) The injury
is characterized by exercise-induced pain in the lower leg with symptoms
commonly occurring in the distal third of the posteromedial tibia border. (1, 2)
There is little information available on the recovery time in patients with
MTSS. Two recently
published studies did assess recovery time.(3, 4) The mean time to recovery in
35 male recruits was 58 (+/- 27) days.(3) Rompe (2010) showed that time to
return to sport was variable and ranged from 6 weeks for some soccer players to
24 weeks for some runners. In military recruits higher BMI will result in a
longer time to full recovery, whereas other prognostic indicators such as a
previous duration of symptoms, functional activity score, the symptom-free
running distance at baseline, increased ankle plantar flexion, decreased
internal range of hip motion and positive navicular drop test were not
associated with time to recovery.(3)
Until recently, MTSS was thought to be due to a tractioninduced periostitis.
However, from
histological studies it is shown that no periostitis is present in patients
with MTTS.(5, 6) A recently published systematic review concluded that MTSS is
caused by bony overload, with numerous studies supporting this theory.(2)
Several imaging studies showed that the tibial cortex is osteopenic and that
the bone marrow is involved.(7, 8) Studies on bone density showed that the
tibial bone density in MTSS subjects is decreased and that bone density returns
to normal values after recovery.(9, 10) The current hypothesis is that the
"bone strain" is caused by a failure of adaption to repetitive bending of the
tibial bone (2). Therefore, MTSS is an injury in which the tibial bone
metabolism is affected instead of the tibial fascia.
The literature supports **rest** as the most important treatment in the acute
phase of MTSS.(1) For many athletes prolonged rest from activity is not ideal
and therefore other therapies are necessary to help the athlete return to
activity quickly and safely.(1)
There is evidence that stimulation with extracorporeal shockwave therapy (ESWT)
will positively influence the bone metabolism by stimulation of bone growth
factor synthesis in human osteoblasts and fibroblasts (11).
The application of ESWT has already been shown to support the healing in tibial
fractures with nonunion.(12) It is therefore reasonable to hypothesize that
extracorporeal shock wave therapy can also enhance the healing of tibial stress
injuries like MTSS.
References
1. Galbraith RM, Lavallee ME. Medial tibial stress syndrome: Conservative
treatment options. Curr Rev Musculoskelet Med. 2009 Oct 7;2(3):127-33.
2. Moen MH, Tol JL, Weir A, Steunebrink M, De Winter TC. Medial tibial stress
syndrome: A
critical review. Sports Med. 2009;39(7):523-46.
3. Moen MH, Bongers T, Bakker EW, Zimmermann WO, Weir A, Tol JL, et al. Risk
factors
and prognostic indicators for medial tibial stress syndrome. Scand J Med Sci
Sports. 2010
Jun 18.
4. Rompe JD, Cacchio A, Furia JP, Maffulli N. Low-energy extracorporeal shock
wave
therapy as a treatment for medial tibial stress syndrome. Am J Sports Med. 2010
Jan;38(1):125-32.
5. Johnell O, Rausing A, Wendeberg B, Westlin N. Morphological bone changes in
shin
splints. Clin Orthop Relat Res. 1982 Jul;(167)(167):180-4.
6. Bhatt R, Lauder I, Finlay DB, Allen MJ, Belton IP. Correlation of bone
scintigraphy and
histological findings in medial tibial syndrome. Br J Sports Med. 2000
Feb;34(1):49-53.
7. Aoki Y, Yasuda K, Tohyama H, Ito H, Minami A. Magnetic resonance imaging in
stress
fractures and shin splints. Clin Orthop Relat Res. 2004 Apr;(421)(421):260-7.
8. Gaeta M, Minutoli F, Vinci S, Salamone I, D'Andrea L, Bitto L, et al.
High-resolution CT
grading of tibial stress reactions in distance runners. AJR Am J Roentgenol.
2006
Sep;187(3):789-93.
9. Magnusson HI, Ahlborg HG, Karlsson C, Nyquist F, Karlsson MK. Low regional
tibial bone
density in athletes with medial tibial stress syndrome normalizes after
recovery from
symptoms. Am J Sports Med. 2003 Jul-Aug;31(4):596-600.
10. Magnusson HI, Westlin NE, Nyqvist F, Gardsell P, Seeman E, Karlsson MK.
Abnormally
decreased regional bone density in athletes with medial tibial stress syndrome.
Am J Sports
Med. 2001 Nov-Dec;29(6):712-5.
11. Hausdorf J, Sievers B, Schmitt- Sody M, et al. Stimulation of bone growth
factor synthesis in human osteoblasts and fibroblasts after extracorporeal
shock wave application. Archn Orthop Trauma Surg 2011; 131:303-309
12. Elster EA, Stojadinovic A, Forsberg J, Shawen S, Andersen RC, Schaden W.
Extracorporeal shock wave therapy for nonunion of the tibia. J Orthop Trauma.
2010 Mar; 24(3):133-41.
Study objective
Aim of this study is to determine the effectiveness of Extracorporeal Shockwave
Therapy (ESWT) on degree of recovery after 3 months in patients with MTSS.
Study design
This study is designed as a randomized, placebo-controlled clinical trial with
a 6 months follow up. It will have two treatment arms: treatment with ESWT in
addition to standard treatment of usual care and a placebo treatment in
addition to standard treatment of usual care.
Intervention
76 participants will be randomized to receive either 3 (placebo)
ESWT-treatments at a weekly interval, in addition to a standard treatment of
usual care (relative rest and resumption of sport activities using an adapted
version of the pain monitoring model).
Study burden and risks
The effort of the participants consists of completing a questionnaire at 4 time
points during the total study period of 29 weeks. Furthermore, the participants
need to visit the Sport medical centre UMCG 3 times. All participants will
receive placebo or treatment with ESWT for 3 weeks, at a weekly interval. There
is only a very, very small chance that side effects of ESWT will occur. So the
potential high benefit and the low risk and burden to the subject justify this
relevant study into the effectiveness of ESWT in physical active men and women.
Hanzeplein 1
9700RB Groningen
NL
Hanzeplein 1
9700RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- Physical active men and women between 18 and 45 years
- Exercise-induces pain in the leg on the posteromedial border of the tibia
- Pain on palpation of the posteromedial border of the tibia for at least 5 centimeters
- Symptoms for at least 6 weeks
- Unilateral and/or bilateral MTSS
Exclusion criteria
- Clinical signs of tibial stress fracture or compartment syndrome
- Neurovascular disease in the under leg
- Pregnancy
- Malignancy and blood clotting disorders
- The use of anticoagulant drugs or corticosteroids
- The use of pacemaker
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL38473.042.11 |