Clinical trial NCT05392036: Effects of Therapeutic Ultrasound Versus Shockwave Therapy in Medial Tibial Stress Syndrome in Recreational Runners
Official title: : Effects of Therapeutic Ultrasound Versus Shockwave Therapy on Pain, Range of Motion and Function in Recreational Runners With Medial Tibial Stress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medial Tibial Stress Syndrome
Keywords: Shock wave
medial tibial stress syndrome
Ultrasound
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project was a Randomized control trial conducted to check the effects of therapeutic ultrasound versus shockwave therapy on pain , range of motion and function in recreational runners with medial tibial stress syndrome so that we can formulate a better and most effective regime for treatment of medial tibial stress. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from Ghurki Trust teaching hospital, horizon hospital and surgimed hospital. Group A participants were given baseline treatment along with shockwave and Group B were given baseline treatment along with therapeutic ultrasound. Assesment was done at baseline and at 2nd week and 6th week post-interrvention . Assessment was done via, Numeric pain rating scale(NPRS), Lower Extermity functional scale LEFS ) and goniometric measurements of shoulder ranges, data was analyzed by using SPSS version 26.

Detailed description: Medial tibial stress syndrome (MTSS) is a common low leg injury. It is described as activity-induced pain along posterior medial border of leg approximately for 5 cm. Most commonly reported by runners and military personnel. Incidence of MTSS ranges between 13.6% to 20% in runners. Significant increase in loading activities or rigorous exercise causing high impact like skiping, jogging can induce MTSS which leads to stress fracture of tibia. Various risk factors are associated with the incidence of medial tibial stress syndrome which includes both intrinsic and extrinsic factors. Current study has involved comparison of therapeutic ultrasound versus shockwave therapy as there is limited knowledge about comparison of therapeutic ultrasound versus shockwave therapy.

Eligibility criteria: Inclusion Criteria:

* Both male and female
* Pain at distal 2/3 of tibia
* Previous history of MTSS
* Recreational runner

Exclusion Criteria:

* History of lower limb fracture

  * Any lower limb surgical history
  * Any malignancy
  * Professional athlete
  * Cardiopulmonary insufficiency

Primary outcomes:
measure: NPRS
timeFrame: 3rd day
measure: LEFS
timeFrame: 3rd day
measure: Goniometry
timeFrame: 3rd day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil-ur Rehman
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClure CJ, Oh R. Medial Tibial Stress Syndrome. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538479/
citation: Okunuki T, Koshino Y, Yamanaka M, Tsutsumi K, Igarashi M, Samukawa M, Saitoh H, Tohyama H. Forefoot and hindfoot kinematics in subjects with medial tibial stress syndrome during walking and running. J Orthop Res. 2019 Apr;37(4):927-932. doi: 10.1002/jor.24223. Epub 2019 Feb 12.
citation: Menendez C, Batalla L, Prieto A, Rodriguez MA, Crespo I, Olmedillas H. Medial Tibial Stress Syndrome in Novice and Recreational Runners: A Systematic Review. Int J Environ Res Public Health. 2020 Oct 13;17(20):7457. doi: 10.3390/ijerph17207457.
citation: Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.
citation: Tsai WC, Tang ST, Liang FC. Effect of therapeutic ultrasound on tendons. Am J Phys Med Rehabil. 2011 Dec;90(12):1068-73. doi: 10.1097/PHM.0b013e31821a70be.
citation: Gomez Garcia S, Ramon Rona S, Gomez Tinoco MC, Benet Rodriguez M, Chaustre Ruiz DM, Cardenas Letrado FP, Lopez-Illescas Ruiz A, Alarcon Garcia JM. Shockwave treatment for medial tibial stress syndrome in military cadets: A single-blind randomized controlled trial. Int J Surg. 2017 Oct;46:102-109. doi: 10.1016/j.ijsu.2017.08.584. Epub 2017 Sep 5.
citation: Naderi A, Bagheri S, Ramazanian Ahoor F, Moen MH, Degens H. Foot Orthoses Enhance the Effectiveness of Exercise, Shockwave, and Ice Therapy in the Management of Medial Tibial Stress Syndrome. Clin J Sport Med. 2022 May 1;32(3):e251-e260. doi: 10.1097/JSM.0000000000000926. Epub 2021 Mar 24.
citation: Moen MH, Holtslag L, Bakker E, Barten C, Weir A, Tol JL, Backx F. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial. Sports Med Arthrosc Rehabil Ther Technol. 2012 Mar 30;4:12. doi: 10.1186/1758-2555-4-12.
citation: Mendez-Rebolledo G, Figueroa-Ureta R, Moya-Mura F, Guzman-Munoz E, Ramirez-Campillo R, Lloyd RS. The Protective Effect of Neuromuscular Training on the Medial Tibial Stress Syndrome in Youth Female Track-and-Field Athletes: A Clinical Trial and Cohort Study. J Sport Rehabil. 2021 Apr 20;30(7):1019-1027. doi: 10.1123/jsr.2020-0376.
citation: Yamasaki S. A Review of the Treatment and Prevention Options for Medial Tibial Stress Syndrome. 2019.