Athletic InjuriesNCT04967924
Sport Specific Training Versus Neuromuscular Training on Field Rugby Players.
A study testing neuromuscular training and Sports specific training in people with Athletic Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
Randomized Clinical Trial in rugby sports club in Lahore. A Sample size of 26 is calculated using epitol.Group A: Sports specific training Treatments will be provided in 30 mins per week for 3 consecutive weeks. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women only
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- neuromuscular training and Sports specific training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jan 2021to 10 Aug 2021
- 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 16 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female rugby players
- Who had suffered minor musculoskeletal injuries that did not preclude their sports participation.
- Age ranges from 16-30
- Being able to cooperate
Who cannot join
- Players presenting injuries which implied radicular compromise (sciatic pain, etc.)
- Players who had suffered moderate or severe musculoskeletal injuries in the past 6 months which precluded their normal sports participation.
- Traumatic pain, fractures or ruptured ligaments.
- Inflammatory and Infectious conditions
- Any recent surgical intervention
- Tumors/malignancy of bone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sport Specific Training Versus Neuromuscular Training on Dynamic Balance, Mobility and Flexibility in Field Rugby Players With Non-specific Low Back Pain. A Randomized Clinical Trial
Randomized Clinical Trial in rugby sports club in Lahore. A Sample size of 26 is calculated using epitol.Group A: Sports specific training Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).
Group B: neuromuscular training Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)
Read the detailed description
Rugby require constant pace changes that generates high musculoskeletal demand in rugby one of the commonly affected area is low back pain that can affect player performance and can be accelerated by injury, health and lifestyle factors and possibly by joint pain or musculoskeletal disorders. Data will be collected from players in registered rugby clubs of district Lahore. Informed consents will be taken from all participants with the knowledge of aims and procedure. The results of this study will help to improve treatment protocols options for players how it affects the rehab process and how it affects the movement and pain how it affects the rehab process and how the pain restricts movements among rugby players. This study will be based on a randomized clinical trial used to study the different level of effectiveness of sports specific training versus neuromuscular training on dynamic balance mobility, flexibility in field rugby players. Subjects with low back pain meeting the predetermined inclusion \& exclusion criteria will be divided into two groups by randomization to avoid any plagiarism. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test will be used for data collection. Subjects in one group will be treated with Bilateral stretches, contract-relax PNF stretching training and other will be treated with weight training, aerobic exercises. Each subject will receive a total four weeks treatment session, thirty minutes sessions will be performed once a week for three weeks. Three evaluations will be performed once before treatment One week after treatment and four week post treatment follow-ups. Sample size 26 each group contains 13 participants. All statistical analysis will be performed with spss16.0.
- Conditions
- Athletic Injuries
- Being tested
- neuromuscular training, Sports specific training
- Keywords
- dynamic balance, Low back pain, neuromuscular training
- Medical subject headings
- Athletic Injuries, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular trainingOther
Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)
Sports specific trainingOther
Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).
| Study group | Role | What they receive |
|---|---|---|
| Sports specific training | Experimental | Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex). Receives: Other: Sports specific training |
| neuromuscular training | Active comparator | Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF) Receives: Other: neuromuscular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
To measure ROM at hip and knee joints
Measured: 6 weeks
Star exclusion test
The test originally incorporated reaching in eight directions while standing on each foot. the 8 different directions are following: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.
SEBT performance scores using the following simple equations:
Average distance in each direction (cm) = Reach 1 + Reach 2 + Reach 3 / 3
Relative (normalised) distance in each direction (%) = Average distance in each direction / leg length * 100
Measured: 6 weeks
Finger tip to floor test
The patient is asked to bend forward and attempt to reach for the floor with their fingertips. The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape.
Mean fingertip- to-floor test was 21.5 21.7cm (range, 0-48cm) for men and 19.6 22cm (range, 0-50cm) for women
Measured: 6 weeks
Secondary outcomes (1)
visual analogue scale for pain
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start9 Jan 2021
- Primary completion9 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967924
- Sponsor's protocol ID
- REC/Lhr/21/0414 Maliah
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.
PubMed 29793126Filipa AR, Smith TR, Paterno MV, Ford KR, Hewett TE. Performance on the Star Excursion Balance Test predicts functional turnout angle in pre-pubescent female dancers. J Dance Med Sci. 2013 Dec;17(4):165-9. doi: 10.12678/1089-313x.17.4.165.
PubMed 24565332Amado-Bonilla E, Pintado-Vidal MI, Mangas-Borrego MI, Marchena-Ortiz E, Barrantes-Chacon J, Moran JM. Comment on "Reference Values of Total Lean Mass, Appendicular Lean Mass, and Fat Mass Measured with Dual-Energy X-ray Absorptiometry in a Healthy Mexican Population".https://www.ncbi.nlm.nih.gov/pubmed/27815567/. Calcif Tissue Int. 2017 Jun;100(6):653. doi: 10.1007/s00223-016-0204-9. Epub 2016 Nov 4. No abstract available.
PubMed 27815567Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.
PubMed 33582009
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sport Specific Training Versus Neuromuscular Training on Dynamic Balance, Mobility and Flexibility in Field Rugby Players With Non-specific Low Back Pain. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04967924
- Acronym / sponsor ID
- REC/Lhr/21/0414 Maliah
- Conditions
- Athletic Injuries
- Keywords
- dynamic balance, Low back pain, neuromuscular training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 20 Jul 2021 (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.
Randomized Clinical Trial in rugby sports club in Lahore. A Sample size of 26 is calculated using epitol.Group A: Sports specific training Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).
Group B: neuromuscular training Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)
Detailed description
Rugby require constant pace changes that generates high musculoskeletal demand in rugby one of the commonly affected area is low back pain that can affect player performance and can be accelerated by injury, health and lifestyle factors and possibly by joint pain or musculoskeletal disorders. Data will be collected from players in registered rugby clubs of district Lahore. Informed consents will be taken from all participants with the knowledge of aims and procedure. The results of this study will help to improve treatment protocols options for players how it affects the rehab process and how it affects the movement and pain how it affects the rehab process and how the pain restricts movements among rugby players. This study will be based on a randomized clinical trial used to study the different level of effectiveness of sports specific training versus neuromuscular training on dynamic balance mobility, flexibility in field rugby players. Subjects with low back pain meeting the predetermined inclusion \& exclusion criteria will be divided into two groups by randomization to avoid any plagiarism. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test will be used for data collection. Subjects in one group will be treated with Bilateral stretches, contract-relax PNF stretching training and other will be treated with weight training, aerobic exercises. Each subject will receive a total four weeks treatment session, thirty minutes sessions will be performed once a week for three weeks. Three evaluations will be performed once before treatment One week after treatment and four week post treatment follow-ups. Sample size 26 each group contains 13 participants. All statistical analysis will be performed with spss16.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sports specific training | Experimental | Other: Sports specific trainingTreatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex). |
| neuromuscular training | Active comparator | Other: neuromuscular trainingTreatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF) |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female rugby players
- Who had suffered minor musculoskeletal injuries that did not preclude their sports participation.
- Age ranges from 16-30
- Being able to cooperate
Key exclusion criteria (6 listed)
- Players presenting injuries which implied radicular compromise (sciatic pain, etc.)
- Players who had suffered moderate or severe musculoskeletal injuries in the past 6 months which precluded their normal sports participation.
- Traumatic pain, fractures or ruptured ligaments.
- Inflammatory and Infectious conditions
- Any recent surgical intervention
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 |
|---|---|---|
| neuromuscular trainingTreatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF) | Other | neuromuscular training |
| Sports specific trainingTreatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex). | Other | Sports specific training |
Primary outcome
Goniometer
Time frame: 6 weeks
To measure ROM at hip and knee joints
Star exclusion test
Time frame: 6 weeks
The test originally incorporated reaching in eight directions while standing on each foot. the 8 different directions are following: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral. SEBT performance scores using the following simple equations: Average distance in each direction (cm) = Reach 1 + Reach 2 + Reach 3 / 3 Relative (normalised) distance in each direction (%) = Average distance in each direction / leg length * 100
Finger tip to floor test
Time frame: 6 weeks
The patient is asked to bend forward and attempt to reach for the floor with their fingertips. The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape. Mean fingertip- to-floor test was 21.5 21.7cm (range, 0-48cm) for men and 19.6 22cm (range, 0-50cm) for women
1 secondary outcome
visual analogue scale for pain
Time frame: 6 weeks
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 24 Aug 2021.
- Background: PubMed 29793126Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.
- Background: PubMed 24565332Filipa AR, Smith TR, Paterno MV, Ford KR, Hewett TE. Performance on the Star Excursion Balance Test predicts functional turnout angle in pre-pubescent female dancers. J Dance Med Sci. 2013 Dec;17(4):165-9. doi: 10.12678/1089-313x.17.4.165.
- Background: PubMed 27815567Amado-Bonilla E, Pintado-Vidal MI, Mangas-Borrego MI, Marchena-Ortiz E, Barrantes-Chacon J, Moran JM. Comment on "Reference Values of Total Lean Mass, Appendicular Lean Mass, and Fat Mass Measured with Dual-Energy X-ray Absorptiometry in a Healthy Mexican Population".https://www.ncbi.nlm.nih.gov/pubmed/27815567/. Calcif Tissue Int. 2017 Jun;100(6):653. doi: 10.1007/s00223-016-0204-9. Epub 2016 Nov 4. No abstract available.
- Background: PubMed 33582009Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.
- Individual participant dataSharing planned: No
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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.
Muhammad Sanaullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular training and Sports specific training in people with Athletic Injuries, 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 4 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: finished, as of the sponsor's last update on 24 Aug 2021. 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?
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?
Goniometer (time frame: 6 weeks). The study lists 3 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 NCT04967924, which also lists 4 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 24 Aug 2021.