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

Primary Purpose

Medial Tibial Stress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
baseline physical therapy treatment along with shockwave therapy
baseline physical therapy treatment along with therapeutic ultrasound
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Tibial Stress Syndrome focused on measuring Shock wave, medial tibial stress syndrome, Ultrasound

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

shockwave therapy

therapeutic ultrasound

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05392036
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Tibial Stress Syndrome
Keywords
Shock wave, medial tibial stress syndrome, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
shockwave therapy
Arm Title
Group B
Arm Type
Other
Arm Description
therapeutic ultrasound
Intervention Type
Other
Intervention Name(s)
baseline physical therapy treatment along with shockwave therapy
Intervention Description
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
Intervention Name(s)
baseline physical therapy treatment along with therapeutic ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
NPRS
Description
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.
Time Frame
3rd day
Title
LEFS
Description
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.
Time Frame
3rd day
Title
Goniometry
Description
A goniometer is an instrument which measures the available range of motion at a joint.
Time Frame
3rd day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil-ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghurki Trust Hospital, Horizon Hospital, Surgimed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30860714
Citation
McClure CJ, Oh R. Medial Tibial Stress Syndrome. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538479/
Results Reference
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PubMed Identifier
30648281
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.
Results Reference
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PubMed Identifier
33066291
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.
Results Reference
background
PubMed Identifier
22433113
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.
Results Reference
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PubMed Identifier
21552108
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.
Results Reference
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PubMed Identifier
28882773
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.
Results Reference
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PubMed Identifier
33797477
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.
Results Reference
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PubMed Identifier
22464032
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.
Results Reference
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PubMed Identifier
33883301
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.
Results Reference
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Citation
Yamasaki S. A Review of the Treatment and Prevention Options for Medial Tibial Stress Syndrome. 2019.
Results Reference
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Effects of Therapeutic Ultrasound Versus Shockwave Therapy in Medial Tibial Stress Syndrome in Recreational Runners

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