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Shin SplintNCT06501430

Effects of Autogenic Inhibition and Reciprocal Inhibition in Amateur Football Players With Shin Splints.

A study testing Heating Therapy and Manual Soft tissue Release in people with Shin Splint, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized controlled trial aims to compare the effectiveness of Autogenic Inhibition and Reciprocal Inhibition in treating shin splints among amateur footballers aged 18-30 from SA Gardens Football Club, Lahore. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Shin Splint
What is being tested?
Heating Therapy and Manual Soft tissue Release
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 sitePakistan
Study dates
23 Dec 2023to Jul 2024
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 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Both genders.
  • Age 18-30 years.
  • Those who are actively taking part in sports from last 1 year.
  • Subjects who have NPRS scores from moderate pain (NPRS 4-6) to severe pain (NPRS 7- 10).
  • Subjects diagnosed with category 2 Shin splints through Shin splint scoring system (Male 2- 14, Female 6-16) and category 3 (Male 14-29, Female 17-29).

Who cannot join

  • History of Central or peripheral vascular disease.
  • History of lower limb fracture / Trauma (Any side) in last 6 months.
  • History of lower limb Surgery (Any side) in last 6 months.
  • History of any malignancy.
  • Leg length discrepancy.
  • Biomechanical imbalances.

Trial locations and contacts

1 site in 1 country.

Zohaib Imran, MS SPT contact

03099977372

zohaibimran83@gmail.com

Muzna Munir, MS SPT contact

+923344265125

muznafmh@gmail.com

Pakistan1 site, 1 recruiting
  • Pakistan Sports Board

    Lahore, Punjab Province, 05450

    Zohaib Imran, MS SPT, 03099977372, zohaibimran83@gmail.com

    Muzna Munir, MSSPT, 03344265125, muznafmh@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Autogenic Inhibition and Reciprocal Inhibition on Pain, Range of Motion, Function and Sports Performance in Amateur Football Players With Shin Splints.

This randomized controlled trial aims to compare the effectiveness of Autogenic Inhibition and Reciprocal Inhibition in treating shin splints among amateur footballers aged 18-30 from SA Gardens Football Club, Lahore. Participants will be recruited through non-probability convenient sampling and randomly assigned into two groups using random number sampling. A single-blind approach will be employed, with one group receiving Autogenic Inhibition treatment and the other receiving Reciprocal Inhibition treatment over a period of four weeks, with three sessions per week. The study will measure outcomes including pain alleviation, improvement in range of motion (ROM), enhanced function, and improved sports performance. This research seeks to provide insights into the benefits of muscle energy techniques for athletes with shin splints, contributing valuable knowledge to sports medicine and rehabilitation practices.

Read the detailed description

Recent literature provides substantial evidence supporting the efficacy of muscle energy techniques (METs), including Autogenic Inhibition, for various musculoskeletal conditions across different populations. Robert F. et al. (2023) conducted a quasi-experimental study using a pre- and post-test design to compare Kalternborn grade III mobilization and METs in 30 patients, finding significant improvements in pain and neck function. Siddiqui M. et al. (2022) demonstrated in a randomized control trial that Autogenic Inhibition was more effective than Reciprocal Inhibition in improving pain, range of motion, and functional disability in patients with mechanical neck pain. Similarly, Osama M. et al. (2022) found Autogenic Inhibition to be the most effective among static stretching, AI-MET, and RI-MET for enhancing isometric muscle strength in neck pain patients. Majeed A. et al. (2021) showed that Autogenic Inhibition had better outcomes than static stretching for hamstring flexibility. Khaled H. Yousef et al. revealed that adding METs to conventional therapy significantly improved pain, impairment, and hip range of motion in patients with chronic discogenic sciatica. A systemic review by Thomas E. et al. (2019) confirmed METs' effectiveness in reducing chronic and acute pain and improving range of motion. Despite these positive findings, there is limited research on METs for sports-related conditions like shin splints. This study aims to fill this gap by examining the specific benefits and drawbacks of a structured MET program for shin splints in a sports environment, providing valuable insights for athletes in managing and preventing overuse and bone stress injuries efficiently.

Conditions
Shin Splint
Being tested
Heating Therapy, Manual Soft tissue Release
Keywords
Football Players, Shin Splints, Pain, Sports performance
Medical subject headings
Medial Tibial Stress Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heating TherapyOther

    Heating Therapy will be performed on subjects along with PNF Exercises.

  • Manual Soft tissue ReleaseOther

    Manual Soft tissue Release will be performed on subjects along with PNF Exercises.

Study groups in NCT06501430
Study groupRoleWhat they receive
Autogenic InhibitionExperimentalGroup 1 will receive Autogenic inhibition with conventional treatment. Autogenic inhibition will be applied to the muscles of the anterior tibial compartment, including Tibialis anterior, extensor hallucis longus, extensor digitorum longus (Perform Dorsi-Flexion), Lateral Tibial Muscles (Peronei), and posterior tibial muscles including, gastrocnemius, soleus and plantaris (Perform Plantarflexion).
Receives: Other: Heating Therapy; Other: Manual Soft tissue Release
Reciprocal RelaxationExperimentalGroup 2 will receive reciprocal inhibition with conventional treatment. Reciprocal inhibition will be applied to the muscles of the anterior tibial compartment, including Tibialis anterior, extensor hallucis longus, extensor digitorum longus (Perform Dorsi-Flexion), Lateral Tibial Muscles (Peronei), and posterior tibial muscles including, gastrocnemius, soleus and plantaris (Perform Plantarflexion).
Receives: Other: Heating Therapy; Other: Manual Soft tissue Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain: Numeric Pain Rating Scale (NPRS)

    NPRS is a reliable tool when measuring pain.

    Measured: 1st day and 12th week.

  2. Ranges of Motion: Goniometery

    The testing position will supine laying with foot in a resting position and towel rolled under ankle, the goniometer center will be on either of the malleolus. The proximal arm will be placed parallel to the ground or tibia/fibula. The distal arm will be moved with the movement of foot into dorsiflexion or plantarflexion.

    Measured: 1st day and 12th week.

  3. Function: Lower Extremity Functioning Scale (LEFS)

    LFS is reliable tool to measure lower extremity functional status. It will take 2-5 minutes with each subject to take th readings.

    Measured: 1st day and 12th week.

  4. Performance: 60m yard test

    1.60m yard test Athlete to sprint as fast as possible over 60 metres after warming up for 10 minutes. The assistant marks out a 60-metre straight section on the track with cones. The assistant gives the command "GO" and starts the stopwatch. The athlete sprints as fast as possible over the 60 metres. The assistant stops the stopwatch as the athlete's torso crosses the finishing line and records the time.

    Measured: 1st day and 12th week.

  5. Performance: Yoyo Test

    Yoyo test: Subject performs an appropriate warm-up. Use cones to mark out two lines 20 meters apart as per the diagram. The participants start with their foot behind one of the lines, and begin running when instructed. They continue running between the two lines, turning when signaled by the recorded beeps. After each minute or so, the pace gets quicker. If the line is not reached in time the subject must run to the line, turn and try to catch up with the pace within 2 more 'beeps. The test is stopped if the subject fails to catch up with the pace within the two ends.

    Measured: 1st day and 12th week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start23 Dec 2023
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
After recruitment and signing the informed consent, baseline readings of all study variables will be taken and all subjects will be assigned into 2 groups, GROUP A (received autogenic inhibition with conventional treatment) and GROUP B (received reciprocal inhibition with conventional physiotherapy treatment) randomly divided by computer-generated software.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501430
Sponsor's protocol ID
REC/RCR & AHS/23/0484
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.

    PubMed 23945179
  • Christakou A, Lavallee D. Rehabilitation from sports injuries: from theory to practice. Perspect Public Health. 2009 May;129(3):120-6. doi: 10.1177/1466424008094802.

    PubMed 19514635
  • Prieto-Gonzalez P, Martinez-Castillo JL, Fernandez-Galvan LM, Casado A, Soporki S, Sanchez-Infante J. Epidemiology of Sports-Related Injuries and Associated Risk Factors in Adolescent Athletes: An Injury Surveillance. Int J Environ Res Public Health. 2021 May 2;18(9):4857. doi: 10.3390/ijerph18094857.

    PubMed 34063226
  • Deshmukh NS, Phansopkar P. Medial Tibial Stress Syndrome: A Review Article. Cureus. 2022 Jul 7;14(7):e26641. doi: 10.7759/cureus.26641. eCollection 2022 Jul.

    PubMed 35949792
  • 5. Patel PY, Patil N. Prevalence of shin splint in recreational marathon runner. International Journal of Physiotherapy. 2020:37-41.

  • Hanlon C, Krzak JJ, Prodoehl J, Hall KD. Effect of Injury Prevention Programs on Lower Extremity Performance in Youth Athletes: A Systematic Review. Sports Health. 2020 Jan/Feb;12(1):12-22. doi: 10.1177/1941738119861117. Epub 2019 Aug 7.

    PubMed 31390306
  • Newsham KR, Beekley MD, Lauber CA. A neuromuscular intervention for exercise-related medial leg pain. J Sport Rehabil. 2012 Feb;21(1):54-62. doi: 10.1123/jsr.21.1.54. Epub 2011 Nov 15.

    PubMed 22104168
  • Lee JH, Park SJ, Na SS. The effect of proprioceptive neuromuscular facilitation therapy on pain and function. J Phys Ther Sci. 2013 Jun;25(6):713-6. doi: 10.1589/jpts.25.713. Epub 2013 Jul 23.

    PubMed 24259836
  • Amako M, Oda T, Masuoka K, Yokoi H, Campisi P. Effect of static stretching on prevention of injuries for military recruits. Mil Med. 2003 Jun;168(6):442-6.

    PubMed 12834132
  • 10. Kumar P, Moitra M. Efficacy of muscle energy technique and pnf stretching compared to conventional physiotherapy in program of hamstring flexibility in chronic nonspecific low back pain. Indian J Physiother Occup Ther Int J. 2015;9(3):103.

  • 11. Robert F, Anandh V, Arunachalam R, Kannan D, Kohilavani S, Thenmozhi M. A Comparative Study Between Kalternborn Grade Iii Mobilization And Muscle Energy Technique To Increase Range And Functional Ability Among Patients With Mechanical Neck Pain. Journal of Pharmaceutical Negative Results. 2023:3307-9.

  • Siddiqui M, Akhter S, Baig AAM. Effects of autogenic and reciprocal inhibition techniques with conventional therapy in mechanical neck pain - a randomized control trial. BMC Musculoskelet Disord. 2022 Jul 25;23(1):704. doi: 10.1186/s12891-022-05668-0.

    PubMed 35879756
  • Osama M. Effects of autogenic and reciprocal inhibition muscle energy techniques on isometric muscle strength in neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(4):555-564. doi: 10.3233/BMR-200002.

    PubMed 33523036
  • 14. Majeed A, Mansoor SR, Arif AB, Yasin MM, Wasim M, Naeem F. Comparison of static stretching and muscle energy techniques on hamstring tightness in asymptomatic females. Foundation University Journal of Rehabilitation Sciences. 2021;1(1):19-23.

  • 15. Yousef KH, Khalefa BM, Badawy MS, Foad A, Abdelmonem AMEG, Al-azab IMA-a. EFFECT OF MUSCLE ENERGY TECHNIQUES ON FUNCTIONAL ABILITIES IN PATIENTS WITH DISCOGENIC UNILATERAL SCIATICA. Turkish Journal of Physiotherapy and Rehabilitation.32:3.

Questions about this trial

What is this clinical trial studying?

A study testing Heating Therapy and Manual Soft tissue Release in people with Shin Splint, run by Riphah International University at 1 site in Pakistan.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. 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 Pakistan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zohaib Imran, MS SPT (03099977372, zohaibimran83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain: Numeric Pain Rating Scale (NPRS) (time frame: 1st day and 12th week.). The study lists 5 primary outcomes in all. 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 NCT06501430, which also lists 27 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 15 Jul 2024.

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