Effects of Therapeutic Ultrasound Versus Shockwave Therapy in Medial Tibial Stress Syndrome in Recreational Runners

Medial Tibial Stress Syndrome Clinical Trial

Official title:

: Effects of Therapeutic Ultrasound Versus Shockwave Therapy on Pain, Range of Motion and Function in Recreational Runners With Medial Tibial Stress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392036
• Other study ID #: REC/RCR & AHS/22/0139 Khizra
• Status: Completed
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Medial Tibial Stress Syndrome
• Syndrome

Intervention

Other:
• baseline physical therapy treatment along with shockwave therapy
Group A, this group will receive conventional therapies along with shockwave therapy. Basic treatment includes icing (15-20 min) to control inflammation, rest, cessation of pain causing activity, anti-inflammatory (NSAIDs) and basic stretching and strengthening exercises. Shockwave therapy is a non-invasive therapeutic modality with convenience, effectiveness and safety. It is used to treat various musculoskeletal disorders without surgery. A session of 30-45 min will include icing 15 min and 5-10 min of shock wave therapy session will be commenced with strengthening and stretching exercises.
• baseline physical therapy treatment along with therapeutic ultrasound
This group will receive therapeutic ultrasound along with conventional treatment. Conventional therapy includes icing, rest, anti-inflammatory drugs, and basic strengthening and stretching exercises. A session of 30-45 min will include icing for 10-15 min therapeutic ultrasound 15min with a frequency 1-3MHz and the session will be ended with strengthening and stretching exercises. Only eligible patients who have fulfilled the inclusion criteria will be included. A daily session of 30-45min for 2 consecutive weeks will be given. A baseline assessment will be done and the patient will be allocated randomly to both groups for two weeks. Re-assessment will be done after 2 weeks. For long term, effects re-assessment will be done after 6 weeks

Locations

Country	Name	City	State
Pakistan	Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

McClure CJ, Oh R. Medial Tibial Stress Syndrome. 2019

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Yamasaki S. A Review of the Treatment and Prevention Options for Medial Tibial Stress Syndrome. 2019.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPRS	Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.	3rd day
Primary	LEFS	It is used to assessment of lower extremity function a questionnaire of 20 questions about a person also ability to perform daily task 0 is minimum score, 80 is maximum score. lower the score greater the disability.	3rd day
Primary	Goniometry	A goniometer is an instrument which measures the available range of motion at a joint.	3rd day