Shin SplintMTSSNCT03198260
Observing the Effect of Fascial Manipulation in Athletes With Shin Splits.Tibial Stress Syndrome.
A study testing Fascial manipulation in people with Shin Splint and Fascial Manipulation, run by Manipal University at 1 site in India.
Trial summary
Aims \& objectives: 1. The aim of the study is to find out the influence of fascial manipulation on running kinematics among athletes with medial tibial stress syndrome (MTSS). 2. The objectives of our study are i. To use fascial manipulation as a mode of treatment in MTSS. ii. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shin Splint, Fascial Manipulation, Running Kinematics
- What is being tested?
- Fascial manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 27 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-40 years, both sexes Athletes with shin pain or diagnosed with MTSS Symptoms lasting for 2-3 weeks in the last 1 month
Who cannot join
- Trauma to lower extremity in the past 3 months Neurological, Cognitive, Psychological factors affecting the test Acute injuries- laceration, sprains, strains, recent fractures Lumbopelvic-hip complex and knee pathologies(intra-articular lesions, osteoarthritis, rheumatic arthritis, osteomyelitis)
Trial locations and contacts
1 site in 1 country.
India1 site
Center for Sport Science Medicine and Research
Udupi, Karnataka, 576104
About this study
Official title: Influence of Fascial Manipulation on Running Kinematics Among Athletes With Medial Tibial Stress Syndrome.
Aims \& objectives:
- The aim of the study is to find out the influence of fascial manipulation on running kinematics among athletes with medial tibial stress syndrome (MTSS).
- The objectives of our study are
- To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running kinematics before and after treatment intervention. iii. To compare pain perception before and after treatment intervention.
Read the detailed description
The justification for study:
- MTSS is associated with altered lower extremity kinematics.
- There is an association between tibial fascia tightness and forces acting along the tibial crest due to alterations in the transfer of energy from foot proximally in the closed kinematic chain.
- Fascial manipulation is found to be effective in improving the pliability of connective tissues in the management of musculoskeletal conditions.
- Therefore there is a need to determine the influence of fascial manipulation on MTSS.
- Conditions
- Shin Splint, Fascial Manipulation, Running Kinematics
- Being tested
- Fascial manipulation
- Medical subject headings
- Medial Tibial Stress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial manipulationOther
Deep frictional massage
| Study group | Role | What they receive |
|---|---|---|
| Fascial Manipulation | Experimental | fascial manipulation is a manual therapy technique were to apply deep frictional massage to the deep fascial structure or point to increase its pliability Receives: Other: Fascial manipulation |
| Running kinematics | Active comparator | the change in a range of joint angles during different phases of running Receives: Other: Fascial manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Self reporting pain intensity after resuming running
Measured: After 5 to 10 mins
Secondary outcomes (1)
Increase in running economy
Increasing in duration of running compared to the first trial
Measured: 15 mins to 45 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 May 2017
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shin SplintStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddhant Shipurka, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198260
- Sponsor's protocol ID
- CTRI/2017/06/008875
- Acronym
- MTSS
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.
PubMed 22341017Winkelmann ZK, Anderson D, Games KE, Eberman LE. Risk Factors for Medial Tibial Stress Syndrome in Active Individuals: An Evidence-Based Review. J Athl Train. 2016 Dec;51(12):1049-1052. doi: 10.4085/1062-6050-51.12.13. Epub 2016 Nov 11.
PubMed 27835043Newman P, Witchalls J, Waddington G, Adams R. Risk factors associated with medial tibial stress syndrome in runners: a systematic review and meta-analysis. Open Access J Sports Med. 2013 Nov 13;4:229-41. doi: 10.2147/OAJSM.S39331.
PubMed 24379729Brown AA. Medial Tibial Stress Syndrome: Muscles Located at the Site of Pain. Scientifica (Cairo). 2016;2016:7097489. doi: 10.1155/2016/7097489. Epub 2016 Mar 15.
PubMed 27066291Souza RB. An Evidence-Based Videotaped Running Biomechanics Analysis. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):217-36. doi: 10.1016/j.pmr.2015.08.006. Epub 2015 Oct 20.
PubMed 26616185Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.
PubMed 23979968Mikolajczyk A, Kociecki M, Zaklukiewicz A, Listewnik M, Gebska M. [USE OF THE STRUCTURAL TENSEGRATION CONCEPT IN THE STECCO FASCIAL MANIPULATION METHOD]. Ann Acad Med Stetin. 2014;60(2):59-64. Polish.
PubMed 26591110Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
PubMed 21589701
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fascial Manipulation on Running Kinematics Among Athletes With Medial Tibial Stress Syndrome.
- ClinicalTrials.gov ID
- NCT03198260
- Acronym / sponsor ID
- MTSS / CTRI/2017/06/008875
- Conditions
- Shin Splint, Fascial Manipulation, Running Kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims \& objectives:
- The aim of the study is to find out the influence of fascial manipulation on running kinematics among athletes with medial tibial stress syndrome (MTSS).
- The objectives of our study are
- To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running kinematics before and after treatment intervention. iii. To compare pain perception before and after treatment intervention.
Detailed description
The justification for study:
- MTSS is associated with altered lower extremity kinematics.
- There is an association between tibial fascia tightness and forces acting along the tibial crest due to alterations in the transfer of energy from foot proximally in the closed kinematic chain.
- Fascial manipulation is found to be effective in improving the pliability of connective tissues in the management of musculoskeletal conditions.
- Therefore there is a need to determine the influence of fascial manipulation on MTSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial Manipulation | Experimental | Other: Fascial manipulationfascial manipulation is a manual therapy technique were to apply deep frictional massage to the deep fascial structure or point to increase its pliability |
| Running kinematics | Active comparator | Other: Fascial manipulationthe change in a range of joint angles during different phases of running |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 18-40 years, both sexes Athletes with shin pain or diagnosed with MTSS Symptoms lasting for 2-3 weeks in the last 1 month
Key exclusion criteria (1 listed)
- Trauma to lower extremity in the past 3 months Neurological, Cognitive, Psychological factors affecting the test Acute injuries- laceration, sprains, strains, recent fractures Lumbopelvic-hip complex and knee pathologies(intra-articular lesions, osteoarthritis, rheumatic arthritis, osteomyelitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial manipulationDeep frictional massage | Other | Fascial Manipulation, Running kinematics |
Primary outcome
Visual analog scale
Time frame: After 5 to 10 mins
Self reporting pain intensity after resuming running
1 secondary outcome
Increase in running economy
Time frame: 15 mins to 45 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Results publication: PubMed 22341017Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.
- Results publication: PubMed 27835043Winkelmann ZK, Anderson D, Games KE, Eberman LE. Risk Factors for Medial Tibial Stress Syndrome in Active Individuals: An Evidence-Based Review. J Athl Train. 2016 Dec;51(12):1049-1052. doi: 10.4085/1062-6050-51.12.13. Epub 2016 Nov 11.
- Results publication: PubMed 24379729Newman P, Witchalls J, Waddington G, Adams R. Risk factors associated with medial tibial stress syndrome in runners: a systematic review and meta-analysis. Open Access J Sports Med. 2013 Nov 13;4:229-41. doi: 10.2147/OAJSM.S39331.
- Results publication: PubMed 27066291Brown AA. Medial Tibial Stress Syndrome: Muscles Located at the Site of Pain. Scientifica (Cairo). 2016;2016:7097489. doi: 10.1155/2016/7097489. Epub 2016 Mar 15.
- Results publication: PubMed 26616185Souza RB. An Evidence-Based Videotaped Running Biomechanics Analysis. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):217-36. doi: 10.1016/j.pmr.2015.08.006. Epub 2015 Oct 20.
- Results publication: PubMed 23979968Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.
- Results publication: PubMed 26591110Mikolajczyk A, Kociecki M, Zaklukiewicz A, Listewnik M, Gebska M. [USE OF THE STRUCTURAL TENSEGRATION CONCEPT IN THE STECCO FASCIAL MANIPULATION METHOD]. Ann Acad Med Stetin. 2014;60(2):59-64. Polish.
- Results publication: PubMed 21589701Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial manipulation in people with Shin Splint and Fascial Manipulation, run by Manipal University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: After 5 to 10 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198260, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.