Postural; DefectNCT05021471
Stretching With And Without Pressure Biofeeback In Patients With Postural Syndrome
A study testing biofeedback and hamstrings stretching in people with Postural; Defect, run by Riphah International University at 1 site in Pakistan.
Trial summary
Postural syndrome describes a variety of conditions in which repetitive or continued bad posture over a long period of time causes pain and reduced function in the muscles and joints. Improper posture can cause pain throughout the length of the spine from the neck to the pelvis. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Postural; Defect
- What is being tested?
- biofeedback and hamstrings stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2021to 28 Feb 2022
- 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
- Males and females of aged 18 to 25 years with hamstrings shortening less than 70 degrees are included in the study
Who cannot join
- Subjects with any past hamstring injury within last 2 years
- Low back pain since past 3 months
- Current or recent (last 3 months) participation in a specific program designed to lengthen the hamstrings are excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Effects Of Stretching With And Without Pressure Biofeeback On Hamstring Muscle Flexibility In Patients With Postural Syndrome
Postural syndrome describes a variety of conditions in which repetitive or continued bad posture over a long period of time causes pain and reduced function in the muscles and joints.
Improper posture can cause pain throughout the length of the spine from the neck to the pelvis. Modern sedentary style of living is one of the main reasons for postural abnormalities evident in modern society. The prolonged sitting hours required in most of the jobs, and educational setups can affect flexibility of soft tissues, especially two joint muscles. Bad posture while standing or walking, if left uncorrected, can worsen over time and lead to pain and dysfunction. Hamstring is a key component of flexibility in the human body and it is more prone to get tightened. Many reasons can lead to the development of hamstring tightness such as genetic predisposition, injury to muscle, and adaptive shortening due to some chronic condition. Short hamstring muscles, because of their attachments to the posterior leg and to the ischial tuberosity, may limit hip flexion ROM and induces posterior pelvic tilt and decreased lumbar lordosis, which can result in LBP The purpose of this study will be to find out the effects of stretching with and without pressure biofeedback unit (PBU) on hamstring muscle flexibility in patients with postural syndrome. The active knee extension (AKE) test will be used to determine the length of the hamstring muscles using a goniometer. A PBU will be used to maintain the anterior pelvic tilt position during active knee extension (AKE) test or stretching, by monitoring the pressure of airbag. Patients will be recruited into study by convenient sampling technique after that will be allocated to groups by simple random assignment. All participants will actively stretch three days per week for four weeks. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25.
- Conditions
- Postural; Defect
- Being tested
- biofeedback, hamstrings stretching
- Keywords
- Pressure biofeedback unit,, Stretching Hamstring Muscles, Active Knee Extension Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedbackOther
Twenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback.
hamstrings stretchingOther
Twenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Twenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback. Receives: Other: biofeedback |
| Group B | Active comparator | Twenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback. Receives: Other: hamstrings stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of joint
universal goniometer as range increase it shows betterment
Measured: 4 weeks
pain of patient
NPRS The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start5 Aug 2021
- Primary completion15 Feb 2022
- Study completion28 Feb 2022
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 Postural; DefectStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021471
- Sponsor's protocol ID
- REC/Lhr/21/0114 Hashim
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, McClure PW, Pratt N. The effect of hamstring muscle stretching on standing posture and on lumbar and hip motions during forward bending. Phys Ther. 1996 Aug;76(8):836-45; discussion 845-9. doi: 10.1093/ptj/76.8.836.
PubMed 8710963Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
PubMed 26240711May S, Nanche G, Pingle S. High frequency of McKenzie's postural syndrome in young population of non-care seeking individuals. J Man Manip Ther. 2011 Feb;19(1):48-54. doi: 10.1179/2042618610Y.0000000004.
PubMed 22294854Makhsous M, Lin F, Bankard J, Hendrix RW, Hepler M, Press J. Biomechanical effects of sitting with adjustable ischial and lumbar support on occupational low back pain: evaluation of sitting load and back muscle activity. BMC Musculoskelet Disord. 2009 Feb 5;10:17. doi: 10.1186/1471-2474-10-17.
PubMed 19193245
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Stretching With And Without Pressure Biofeeback On Hamstring Muscle Flexibility In Patients With Postural Syndrome
- ClinicalTrials.gov ID
- NCT05021471
- Acronym / sponsor ID
- REC/Lhr/21/0114 Hashim
- Conditions
- Postural; Defect
- Keywords
- Pressure biofeedback unit,, Stretching Hamstring Muscles, Active Knee Extension Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Aug 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.
Postural syndrome describes a variety of conditions in which repetitive or continued bad posture over a long period of time causes pain and reduced function in the muscles and joints.
Improper posture can cause pain throughout the length of the spine from the neck to the pelvis. Modern sedentary style of living is one of the main reasons for postural abnormalities evident in modern society. The prolonged sitting hours required in most of the jobs, and educational setups can affect flexibility of soft tissues, especially two joint muscles. Bad posture while standing or walking, if left uncorrected, can worsen over time and lead to pain and dysfunction. Hamstring is a key component of flexibility in the human body and it is more prone to get tightened. Many reasons can lead to the development of hamstring tightness such as genetic predisposition, injury to muscle, and adaptive shortening due to some chronic condition. Short hamstring muscles, because of their attachments to the posterior leg and to the ischial tuberosity, may limit hip flexion ROM and induces posterior pelvic tilt and decreased lumbar lordosis, which can result in LBP The purpose of this study will be to find out the effects of stretching with and without pressure biofeedback unit (PBU) on hamstring muscle flexibility in patients with postural syndrome. The active knee extension (AKE) test will be used to determine the length of the hamstring muscles using a goniometer. A PBU will be used to maintain the anterior pelvic tilt position during active knee extension (AKE) test or stretching, by monitoring the pressure of airbag. Patients will be recruited into study by convenient sampling technique after that will be allocated to groups by simple random assignment. All participants will actively stretch three days per week for four weeks. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: biofeedbackTwenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback. |
| Group B | Active comparator | Other: hamstrings stretchingTwenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females of aged 18 to 25 years with hamstrings shortening less than 70 degrees are included in the study
Key exclusion criteria (3 listed)
- Subjects with any past hamstring injury within last 2 years
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 |
|---|---|---|
| biofeedbackTwenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback. | Other | Group A |
| hamstrings stretchingTwenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback. | Other | Group B |
Primary outcome
range of joint
Time frame: 4 weeks
universal goniometer as range increase it shows betterment
pain of patient
Time frame: 4 weeks
NPRS The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
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 22 Apr 2022.
- Background: PubMed 8710963Li Y, McClure PW, Pratt N. The effect of hamstring muscle stretching on standing posture and on lumbar and hip motions during forward bending. Phys Ther. 1996 Aug;76(8):836-45; discussion 845-9. doi: 10.1093/ptj/76.8.836.
- Background: PubMed 26240711Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
- Background: PubMed 22294854May S, Nanche G, Pingle S. High frequency of McKenzie's postural syndrome in young population of non-care seeking individuals. J Man Manip Ther. 2011 Feb;19(1):48-54. doi: 10.1179/2042618610Y.0000000004.
- Background: PubMed 19193245Makhsous M, Lin F, Bankard J, Hendrix RW, Hepler M, Press J. Biomechanical effects of sitting with adjustable ischial and lumbar support on occupational low back pain: evaluation of sitting load and back muscle activity. BMC Musculoskelet Disord. 2009 Feb 5;10:17. doi: 10.1186/1471-2474-10-17.
- 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 Salman Bashir, PhD 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 biofeedback and hamstrings stretching in people with Postural; Defect, 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 1 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 22 Apr 2022. 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?
range of joint (time frame: 4 weeks). The study lists 2 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 NCT05021471, 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 22 Apr 2022.