Low Back Pain, MechanicalNCT06369558
Plyometric Exercise Training in Athletes With Chronic Low Back Pain
A study testing PLYOMETRIC TRAINING and CLASSIC PHYSIOTHERAPY PROGRAM in people with Low Back Pain, Mechanical, run by Ugur Cavlak at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- PLYOMETRIC TRAINING and CLASSIC PHYSIOTHERAPY PROGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 4 Apr 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-25
- Being a licensed athlete (male of famele)
- Low back pain is chronic and lasts at least 3 months
Who cannot join
- Having had back pain or any surgery that caused it in the last year.
- Having cardiovaskular disease
- Doping and using banned substances.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, Zeytinburnu, 34010
About this study
Official title: Effectiveness of Plyometric Exercise Training in Athletes With Chronic Low Back Pain: A Randomized Controlled Trial
The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study.
Read the detailed description
Visual Analog Scale (VAS) for pain assessment and Oswestry Disability Index for disability level will be used. Sit and Reach Test, Vertical Jump, Flamingo balance test and Shuttle Running test (20 min.) will be used to measure the physical functioning of the participants. Manual Muscle testing will also be used to measure the participants' lower and upper muscles. The participants were divided into two groups. The interventional program will be finished after 6 weeks (3 days a week). The program includes; physical therapy session (Hot packed, vacuum interferential current therapy, therapeutic ultrasound, exercises) and plyometric exercises.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- PLYOMETRIC TRAINING, CLASSIC PHYSIOTHERAPY PROGRAM
- Keywords
- Chronic Low Pain, Plyometric exercise, Physiotherapy, Athlete
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLYOMETRIC TRAININGOther
A 6 WEEK (3 TIMES A WEEK) CONSISTING OF JUMPING SINGLE LEG BRIDGE AND JUMPED SQUAT
CLASSIC PHYSIOTHERAPY PROGRAMOther
HOT PACKED ENTEFERANTIAL CURRENT THERAPY AND US THERAPY
| Study group | Role | What they receive |
|---|---|---|
| PYLOMETRIC | Experimental | PLYOMETRIC TRAINING Receives: Other: PLYOMETRIC TRAINING |
| CONTROL | Active comparator | CLASSIC PHYSIOTHERAPY PROGRAM Receives: Other: PLYOMETRIC TRAINING; Other: CLASSIC PHYSIOTHERAPY PROGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOG SCALE
TO MEASURE PAIN INTENSITY (MİN.-MAX.:0-10 POINT)
Measured: baseline and immediately after the intervention
OSWESTRY DISABILITY INDEX
TO MEASURE PAIN DISABILITY (MİN.-MAX.:0-50 POİNT)
Measured: baseline and immediately after the intervention
SIT AND REACH TEST
TO MEASURE MUSCLE FLEXIBILITY (MİN.-MAX.:0-29 POİNT)
Measured: baseline and immediately after the intervention
VERTICAL JUMP TEST
EXPECT TO HİGER SCOE İN CENTIMETER
Measured: baseline and immediately after the intervention
FLAMINGO BALANCE TEST
TO MEASURE BALANCE (MİN.-MAX.:0-60 SECOND)
Measured: baseline and immediately after the intervention
SHUTTLE RUNNİNG (20 MİN.)
TO MEASURE FUNCTIONALITY
Measured: baseline and immediately after the intervention
MANUAL MUSCLE STRENGTH TEST
TO MEASURE MUSCLE STRENGTH
Measured: baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ugur Cavlak
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Sponsor-investigator, Ugur Cavlak, Biruni University
- Investigators
- UGUR CAVLAK, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369558
- Sponsor's protocol ID
- BiruniUniversi
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang PY, Jankaew A, Lin CF. Effects of Plyometric and Balance Training on Neuromuscular Control of Recreational Athletes with Functional Ankle Instability: A Randomized Controlled Laboratory Study. Int J Environ Res Public Health. 2021 May 15;18(10):5269. doi: 10.3390/ijerph18105269.
PubMed 34063454
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Plyometric Exercise Training in Athletes With Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06369558
- Acronym / sponsor ID
- BiruniUniversi
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Chronic Low Pain, Plyometric exercise, Physiotherapy, Athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ugur CavlakUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 17 Apr 2024 (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.
The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study.
Detailed description
Visual Analog Scale (VAS) for pain assessment and Oswestry Disability Index for disability level will be used. Sit and Reach Test, Vertical Jump, Flamingo balance test and Shuttle Running test (20 min.) will be used to measure the physical functioning of the participants. Manual Muscle testing will also be used to measure the participants' lower and upper muscles. The participants were divided into two groups. The interventional program will be finished after 6 weeks (3 days a week). The program includes; physical therapy session (Hot packed, vacuum interferential current therapy, therapeutic ultrasound, exercises) and plyometric exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PYLOMETRIC | Experimental | Other: PLYOMETRIC TRAININGPLYOMETRIC TRAINING |
| CONTROL | Active comparator | Other: PLYOMETRIC TRAINING, Other: CLASSIC PHYSIOTHERAPY PROGRAMCLASSIC PHYSIOTHERAPY PROGRAM |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-25
- Being a licensed athlete (male of famele)
- Low back pain is chronic and lasts at least 3 months
Key exclusion criteria (3 listed)
- Having had back pain or any surgery that caused it in the last year.
- Having cardiovaskular disease
- Doping and using banned substances.
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 |
|---|---|---|
| PLYOMETRIC TRAININGA 6 WEEK (3 TIMES A WEEK) CONSISTING OF JUMPING SINGLE LEG BRIDGE AND JUMPED SQUAT | Other | CONTROL, PYLOMETRIC |
| CLASSIC PHYSIOTHERAPY PROGRAMHOT PACKED ENTEFERANTIAL CURRENT THERAPY AND US THERAPY | Other | CONTROL |
Primary outcome
VISUAL ANALOG SCALE
Time frame: baseline and immediately after the intervention
TO MEASURE PAIN INTENSITY (MİN.-MAX.:0-10 POINT)
OSWESTRY DISABILITY INDEX
Time frame: baseline and immediately after the intervention
TO MEASURE PAIN DISABILITY (MİN.-MAX.:0-50 POİNT)
SIT AND REACH TEST
Time frame: baseline and immediately after the intervention
TO MEASURE MUSCLE FLEXIBILITY (MİN.-MAX.:0-29 POİNT)
VERTICAL JUMP TEST
Time frame: baseline and immediately after the intervention
EXPECT TO HİGER SCOE İN CENTIMETER
FLAMINGO BALANCE TEST
Time frame: baseline and immediately after the intervention
TO MEASURE BALANCE (MİN.-MAX.:0-60 SECOND)
SHUTTLE RUNNİNG (20 MİN.)
Time frame: baseline and immediately after the intervention
TO MEASURE FUNCTIONALITY
MANUAL MUSCLE STRENGTH TEST
Time frame: baseline and immediately after the intervention
TO MEASURE MUSCLE STRENGTH
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 17 Apr 2024.
- Results publication: PubMed 34063454Huang PY, Jankaew A, Lin CF. Effects of Plyometric and Balance Training on Neuromuscular Control of Recreational Athletes with Functional Ankle Instability: A Randomized Controlled Laboratory Study. Int J Environ Res Public Health. 2021 May 15;18(10):5269. doi: 10.3390/ijerph18105269.
- 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.
UGUR CAVLAK principal investigator
Biruni 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 PLYOMETRIC TRAINING and CLASSIC PHYSIOTHERAPY PROGRAM in people with Low Back Pain, Mechanical, run by Ugur Cavlak at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 17 Apr 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 Turkey (Türkiye). 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: baseline and immediately after the intervention). The study lists 7 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 NCT06369558, which also lists 1 linked publication.
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 17 Apr 2024.