NCT05392036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Shock wavemedial tibial stress syndromeUltrasound

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Goniometry

    A goniometer is an instrument which measures the available range of motion at a joint.

    3rd day

Study Arms (2)

Group A

EXPERIMENTAL

shockwave therapy

Other: baseline physical therapy treatment along with shockwave therapy

Group B

OTHER

therapeutic ultrasound

Other: baseline physical therapy treatment along with therapeutic ultrasound

Interventions

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 A

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

Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of lower limb fracture
  • Any lower limb surgical history
  • Any malignancy
  • Professional athlete
  • Cardiopulmonary insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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/

    PMID: 30860714BACKGROUND
  • 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.

    PMID: 30648281BACKGROUND
  • 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.

    PMID: 33066291BACKGROUND
  • Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.

    PMID: 22433113BACKGROUND
  • 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.

    PMID: 21552108BACKGROUND
  • 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.

    PMID: 28882773BACKGROUND
  • 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.

    PMID: 33797477BACKGROUND
  • 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.

    PMID: 22464032BACKGROUND
  • 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.

    PMID: 33883301BACKGROUND
  • Yamasaki S. A Review of the Treatment and Prevention Options for Medial Tibial Stress Syndrome. 2019.

    BACKGROUND

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Syed Shakil-ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations