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

NCT ID: NCT05392036

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2023-01-30

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.

Conditions

Medial Tibial Stress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

shockwave therapy

Group Type: EXPERIMENTAL

baseline physical therapy treatment along with shockwave therapy

Intervention Type: OTHER

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.

Group B

therapeutic ultrasound

Group Type: OTHER

baseline physical therapy treatment along with therapeutic ultrasound

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syed Shakil-ur Rehman

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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/

Reference Type: BACKGROUND

PMID: 30860714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30648281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33066291 (View on PubMed)

Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.

Reference Type: BACKGROUND

PMID: 22433113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21552108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28882773 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33797477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22464032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33883301 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

REC/RCR & AHS/22/0139 Khizra

Identifier Type: -

Identifier Source: org_study_id