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

July 12, 2024 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05450
        • Recruiting
        • Pakistan Sports Board
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zohaib Imran, MS SPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Both genders.
  2. Age 18-30 years.
  3. Those who are actively taking part in sports from last 1 year.
  4. Subjects who have NPRS scores from moderate pain (NPRS 4-6) to severe pain (NPRS 7- 10).
  5. 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Autogenic Inhibition
Group 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).
Other: Heating Therapy
Heating Therapy will be performed on subjects along with PNF Exercises.
Other: Manual Soft tissue Release
Manual Soft tissue Release will be performed on subjects along with PNF Exercises.
Experimental: Reciprocal Relaxation
Group 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).
Other: Heating Therapy
Heating Therapy will be performed on subjects along with PNF Exercises.
Other: Manual Soft tissue Release
Manual Soft tissue Release will be performed on subjects along with PNF Exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain: Numeric Pain Rating Scale (NPRS)
Time Frame: 1st day and 12th week.
NPRS is a reliable tool when measuring pain.
1st day and 12th week.
Ranges of Motion: Goniometery
Time Frame: 1st day and 12th week.
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.
1st day and 12th week.
Function: Lower Extremity Functioning Scale (LEFS)
Time Frame: 1st day and 12th week.
LFS is reliable tool to measure lower extremity functional status. It will take 2-5 minutes with each subject to take th readings.
1st day and 12th week.
Performance: 60m yard test
Time Frame: 1st day and 12th week.
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.
1st day and 12th week.
Performance: Yoyo Test
Time Frame: 1st day and 12th week.
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.
1st day and 12th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zohaib Imran, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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