Low Back PainNCT05995145
Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting
A study testing Active hamstring flexibility exercises with hip flexion mobilization in people with Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Hip flexion is a normal part of everyday functional activities, including walking and sitting. The length of the hamstring influences on movement of the pelvis during hip flexion, consequently influencing lumbar lordosis. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Active hamstring flexibility exercises with hip flexion mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2023to 12 Feb 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
- students in Physical Education (18-25 years old)
- with non-specific LBP (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), the pain of at least 3 months duration, without radiation to legs
- without a surgical history due to spinal problems
- didn't previously continue the hamstring stretches exercises
- with hamstring muscle shortness
Who cannot join
- spinal pathology (eg, tumor, infection, fracture, inflammatory disease
- disc herniation and leg length discrepancy over 1cm
- pregnancy
- nerve root compromise
- previous spinal surgery
- major surgery scheduled during treatment or follow-up period
Show all 9Show fewer
- presence of any contraindication to exercise
- medically verified chronic back disorde
- menstrual pain
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala Podlaska
Biała Podlaska, 21-500
About this study
Official title: A 8-week Randomized Controlled Trial of Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People: Study Protocol
Hip flexion is a normal part of everyday functional activities, including walking and sitting. The length of the hamstring influences on movement of the pelvis during hip flexion, consequently influencing lumbar lordosis. In most activities, the hamstring muscles are active and it is necessary to keep them at normal length. Sitting posture is responsible for the loss of the natural curvature of the lumbar spine, because the hip flexion and pelvic extension flatten the lumbar vertebrae (i.e., lumbopelvic rhythm). Furthermore tightened hamstring increases posterior pelvic tilt and reduces lumbar lordosis, which can tend to low back pain (LBP). Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.
The aim of this RCT is to present a protocol for evaluating the effect of 8-week active hamstring flexibility exercises with hip flexion mobilization in reducing LBP and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP.
Read the detailed description
Background:
Limited lower extremity muscle flexibility, such as hamstring, iliopsoas, quadriceps, and limited hip range of motion are risk factors for low back pain (LBP) in young people. LBP has increased by 49.8-50.7% over the last twenty years which highlighted the increase in the dominance of LBP especially among young people. Flexibility is an essential factor in physical fitness, which has a significant role in the functional development of the musculoskeletal system and the optimization of muscle work. To prevent pain or perceived musculoskeletal discomfort, various flexibility exercises including exercise stretches of the hamstring muscles have been recommended. Improving the hip flexion technique requires hip power and stability in the lumbar spine. In hamstring flexibility training, we should create an opportunity to practice movement and develop correct patterns using the hip flexion and extension pattern while maintaining the stability of the lumbar spine. Keeping the torso straight while working the hips and knees is one of the basic principles of protecting the spine in the lumbar region. Maintaining a neutral lower spine protects passive tissues and allows for better mobilization of the hips. Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.
Objective:
This randomized controlled trial aims to investigate the effect of a 8-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reducing low back pain (LBP) and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP.
Methods:
This will be a single-blind, randomized controlled trial with pre and post-intervention assessment. Participants were recruited from Physical Education Faculty students and randomly assigned to either the experimental group (hamstring stretching exercises) or the control group (no intervention). The hamstring stretching exercises group will be held five a week, 20 min per session for 8 weeks. The primary outcomes will be average pain intensity (Visual Analogue Scale, VAS), functional disability (Oswestry Disability Index), perceived musculoskeletal discomfort during prolonged sitting (Borg scale) , and the global perceived improvement (The Global Perceived Effect, 7-point Likert scale). Secondary outcome will be flexibility of the hamstring (SLR test).
Expected outcomes:
The findings of this study might provide information about a 8-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reduction of LBP and musculoskeletal discomfort during prolonged sitting in young adults. These results might highlight the importance of incorporating targeted flexibility exercises in the management of non-specific LBP, particularly in individuals with a sedentary lifestyle. Further research is warranted to explore the long-term effects and applicability of these interventions in larger populations.
- Conditions
- Low Back Pain
- Being tested
- Active hamstring flexibility exercises with hip flexion mobilization
- Keywords
- exercise, treatment, spine, posture, students, pain, hamstring muscles
- Medical subject headings
- Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active hamstring flexibility exercises with hip flexion mobilizationBehavioural
8 weeks x 5 times per week for 20 min. In the experimental intervention, the exercise program will be based on participant education, home-based individual exercises, and regular group meetings for check-ups by a physiotherapist according to a precise set schedule.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The hamstring stretching exercises program will be conducted five times a week, 20 min per session, for 8 weeks. The exercises will be supervised by an experienced physiotherapist with five years of clinical experience. The intervention will be divided into two parts. The first part will include exercises with a massage foam roller. The second part will include exercises of active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine. Receives: Behavioral: Active hamstring flexibility exercises with hip flexion mobilization |
| Control group | No intervention | Participants assigned to the control group will receive an self-care recommendations book. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The Visual Analogue Scale (VAS) will be used to assess average pain intensity graded from 0 (no pain) up to 10 (unbearable pain). Mild pain or no pain will be defined as VAS 0-3, moderate pain as VAS 4-6, and severe pain as VAS 7-10. Participants will be asked to rate their maximum pain intensity from the last 3 months.
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
Functional Disability
The Revised Oswestry Low Back Pain Disability Index will be used to assess the level of functional disabilities of participants resulting from LBP. The questionnaire consists of 10 items related to different aspects of function regarding activities of daily living (ADL). Each item will be scored from 0 to 5, with higher values representing greater disability. The total score will be multiplied by 2 and expressed as a percentage.
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
Perceived musculoskeletal discomfort during prolonged sitting
The Borg CR-10 scale will be used to assess the perceived musculoskeletal discomfort during 1 hour of sitting named as prolonged sitting. The Borg CR-10 scale is presented in such a way that test subjects can indicate in which parts of the body feel discomfort (i.e. neck, shoulder, upper back, lower back, hip/thigh, and knee) and the degree of discomfort they feel (on a scale from 0 to 10, 0 being no discomfort and 10 being extremely uncomfortable).
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
The global perceived improvement
The Global Perceived Effect (GPE) will be used to assess the global perceived improvement. The investigator will ask the student to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).
Measured: Completion of 8 week intervention
Secondary outcomes (1)
Flexibility of the hamstring
The flexibility of the hamstring will be assessed through the SLR.The SLR is a passive test performed unilaterally. The criterion score of hamstring extensibility will be the maximum angle (degree) read from the goniometer at the point of maximum hip flexion. Angles will be recorded to the nearest degree for each leg. Two trials will give for each leg and the average of the two trials on each side will use for subsequent analysis. A subject's hamstring muscles will be considered tight (in a shortened position) if there was an SLR of ≤70 degrees.
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Dec 2023
- Primary completion31 Jan 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tehran
- Responsible party
- Principal investigator, Magdalena Plandowska, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995145
- Sponsor's protocol ID
- 14/03/04/2023
- Status last verified
- Nov 2023
- First submitted
- 29 Jul 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-week Randomized Controlled Trial of Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People: Study Protocol
- ClinicalTrials.gov ID
- NCT05995145
- Acronym / sponsor ID
- 14/03/04/2023
- Conditions
- Low Back Pain
- Keywords
- exercise, treatment, spine, posture, students, pain, hamstring muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Collaborators
- University of Tehran
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 16 Aug 2023 (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.
Hip flexion is a normal part of everyday functional activities, including walking and sitting. The length of the hamstring influences on movement of the pelvis during hip flexion, consequently influencing lumbar lordosis. In most activities, the hamstring muscles are active and it is necessary to keep them at normal length. Sitting posture is responsible for the loss of the natural curvature of the lumbar spine, because the hip flexion and pelvic extension flatten the lumbar vertebrae (i.e., lumbopelvic rhythm). Furthermore tightened hamstring increases posterior pelvic tilt and reduces lumbar lordosis, which can tend to low back pain (LBP). Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.
The aim of this RCT is to present a protocol for evaluating the effect of 8-week active hamstring flexibility exercises with hip flexion mobilization in reducing LBP and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP.
Detailed description
Background:
Limited lower extremity muscle flexibility, such as hamstring, iliopsoas, quadriceps, and limited hip range of motion are risk factors for low back pain (LBP) in young people. LBP has increased by 49.8-50.7% over the last twenty years which highlighted the increase in the dominance of LBP especially among young people. Flexibility is an essential factor in physical fitness, which has a significant role in the functional development of the musculoskeletal system and the optimization of muscle work. To prevent pain or perceived musculoskeletal discomfort, various flexibility exercises including exercise stretches of the hamstring muscles have been recommended. Improving the hip flexion technique requires hip power and stability in the lumbar spine. In hamstring flexibility training, we should create an opportunity to practice movement and develop correct patterns using the hip flexion and extension pattern while maintaining the stability of the lumbar spine. Keeping the torso straight while working the hips and knees is one of the basic principles of protecting the spine in the lumbar region. Maintaining a neutral lower spine protects passive tissues and allows for better mobilization of the hips. Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.
Objective:
This randomized controlled trial aims to investigate the effect of a 8-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reducing low back pain (LBP) and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP.
Methods:
This will be a single-blind, randomized controlled trial with pre and post-intervention assessment. Participants were recruited from Physical Education Faculty students and randomly assigned to either the experimental group (hamstring stretching exercises) or the control group (no intervention). The hamstring stretching exercises group will be held five a week, 20 min per session for 8 weeks. The primary outcomes will be average pain intensity (Visual Analogue Scale, VAS), functional disability (Oswestry Disability Index), perceived musculoskeletal discomfort during prolonged sitting (Borg scale) , and the global perceived improvement (The Global Perceived Effect, 7-point Likert scale). Secondary outcome will be flexibility of the hamstring (SLR test).
Expected outcomes:
The findings of this study might provide information about a 8-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reduction of LBP and musculoskeletal discomfort during prolonged sitting in young adults. These results might highlight the importance of incorporating targeted flexibility exercises in the management of non-specific LBP, particularly in individuals with a sedentary lifestyle. Further research is warranted to explore the long-term effects and applicability of these interventions in larger populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Active hamstring flexibility exercises with hip flexion mobilizationThe hamstring stretching exercises program will be conducted five times a week, 20 min per session, for 8 weeks. The exercises will be supervised by an experienced physiotherapist with five years of clinical experience. The intervention will be divided into two parts. The first part will include exercises with a massage foam roller. The second part will include exercises of active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine. |
| Control group | No intervention | –Participants assigned to the control group will receive an self-care recommendations book. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- students in Physical Education (18-25 years old)
- with non-specific LBP (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), the pain of at least 3 months duration, without radiation to legs
- without a surgical history due to spinal problems
- didn't previously continue the hamstring stretches exercises
- with hamstring muscle shortness
Key exclusion criteria (9 listed)
- spinal pathology (eg, tumor, infection, fracture, inflammatory disease
- disc herniation and leg length discrepancy over 1cm
- pregnancy
- nerve root compromise
- previous spinal surgery
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 |
|---|---|---|
| Active hamstring flexibility exercises with hip flexion mobilization8 weeks x 5 times per week for 20 min. In the experimental intervention, the exercise program will be based on participant education, home-based individual exercises, and regular group meetings for check-ups by a physiotherapist according to a precise set schedule. | Behavioural | Experimental group |
Primary outcome
Pain Intensity
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
The Visual Analogue Scale (VAS) will be used to assess average pain intensity graded from 0 (no pain) up to 10 (unbearable pain). Mild pain or no pain will be defined as VAS 0-3, moderate pain as VAS 4-6, and severe pain as VAS 7-10. Participants will be asked to rate their maximum pain intensity from the last 3 months.
Functional Disability
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
The Revised Oswestry Low Back Pain Disability Index will be used to assess the level of functional disabilities of participants resulting from LBP. The questionnaire consists of 10 items related to different aspects of function regarding activities of daily living (ADL). Each item will be scored from 0 to 5, with higher values representing greater disability. The total score will be multiplied by 2 and expressed as a percentage.
Perceived musculoskeletal discomfort during prolonged sitting
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)
The Borg CR-10 scale will be used to assess the perceived musculoskeletal discomfort during 1 hour of sitting named as prolonged sitting. The Borg CR-10 scale is presented in such a way that test subjects can indicate in which parts of the body feel discomfort (i.e. neck, shoulder, upper back, lower back, hip/thigh, and knee) and the degree of discomfort they feel (on a scale from 0 to 10, 0 being no discomfort and 10 being extremely uncomfortable).
The global perceived improvement
Time frame: Completion of 8 week intervention
The Global Perceived Effect (GPE) will be used to assess the global perceived improvement. The investigator will ask the student to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).
1 secondary outcome
Flexibility of the hamstring
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 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 14 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active hamstring flexibility exercises with hip flexion mobilization in people with Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 9 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 14 Feb 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 Poland. 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?
Pain Intensity (time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.