Low Back PainNCT07576101
Low Blood Flow Restriction Training on Low Back Pain
A study testing Conventional PT and Low Blood Flow Restriction Training in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to find the effectiveness of low load blood restriction training on improving hamstring muscle strength, alleviating pain and reducing functional disability in nonspecific low back pain patients Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conventional PT and Low Blood Flow Restriction Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2026to 12 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Both gender
- Age is between 18-45 years
- Individuals with pain localized posteriorly below the costal margin and above the inferior gluteal folds for more than 12 weeks
- A score greater than or equal to 4/10 on Numeric Pain Rating Scale (NPRS)
- Hamstring muscle strength graded between (3- to 4) on MMT
- Proximal thigh circumference between (27.0 cm to 56.0 cm), measured 10cm below the inguinal crease
- Eligible for BFR training as per the Blood Flow Restriction Blood Flow Training Questionnaire
Who cannot join
- Participants falling in this category would be excluded from the study.
- Patients of spinal stenosis, disc herniation spondylolisthesis, spondylosis or osteoporosis will be excluded
- Participants had a history of hip or lower extremity pathology requiring medical or surgical intervention.
- History of venous thromboembolism (VTE), clotting or other hematologic disorder
- Peripheral arterial disease, hypertension (blood pressure >140/90 mm Hg), coronary artery disease
- Current Pregnancy
- Patients who had difficulties in exercise performance due to mental problems.
- Spinal cord infection like Cauda equina syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute Of Rehabilitation Medicine G-8/2, Islamabad
Islamabad, 46000
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
MUZAMMEL FATIMA, MS-OMPT*
About this study
Official title: Effect of Low Blood Flow Restriction Training on Nonspecific Low Back Pain Patients
The aim of this randomized controlled trial is to find the effectiveness of low load blood restriction training on improving hamstring muscle strength, alleviating pain and reducing functional disability in nonspecific low back pain patients
Read the detailed description
Low back pain (LBP)-related disability and the related socioeconomic burden remain high despite the many treatment options and health care resources available for LBP. LBP can be caused by a specific pathology or trauma; however, in >90% of cases, an underlying disease is absent. The clinical course of this called as nonspecific LBP which is the most common type of low back pain and, some patients recover within weeks, and others experience persistent disabling symptoms leading to chronic LBP. Chronic low back pain (CLBP, pain lasting more than 12 weeks duration) is one of the most common chronic musculoskeletal disorders with high prevalence rates worldwide. Patients with CLBP have varying degrees of pain in the lumbar region of the spine, generally located between the lower ribs and the gluteal region.
Approximately 85% of patients have chronic non-specific low back pain (CNLBP) who do not have a specific patho-anatomical cause attributable to their pain in clinical examination. More than 50% of people in the United States are affected by CLBP. 90% adults will experience LBP in their lifetime, and the recurrence of LBP following chronic episode ranges from 24 to 87 %. The prevalence of LBP in children and adolescents has reaching around 39% of LBP lifetime prevalence in adults at 18 years of age. The prevalence of low back pain was 55.51% in Lahore, Pakistan.
Common nonspecific LBP symptoms include paravertebral muscle spasms, tight hamstrings, trigger points in the muscles, limited spinal range of motion, discomfort and pain. CNLBP is the most common musculoskeletal condition impacting performance leads to functional disability. Various factors associated with CLBP, including smoking, excessive BMI, poor muscle endurance, occupational ergonomic factors, poor posture, altered muscle firing rates, muscular imbalance, psychological factors as depression, inflexibility of the lower extremities, and leg length discrepancies.
Muscle tightness linked to postural disturbances and reduced extensibility resulting from increased hamstring stiffness could be a possible contributing factor to low back pain. Tight hamstring draws the pelvic into posterior rotation with greater flattening of lumbar lordosis which increase mechanical stress on the spinal soft tissues and altered hip biomechanics and lumbopelvic rhythm. If hamstrings are tight, then blood supply will be squeezed out of them leads to decreased muscle capacity, deconditioning and reduced strength which may cause abnormal changes in the bodily posture lead to lumbar hypo-lordosis causing LBP.
Chronic low back pain involves complex interaction of neuromuscular, inflammatory and neurophysiological processes that leads to constant pain. Long-term alterations in movement patterns due to muscular tightness result in structural changes within muscle fibers. The mechanism involved behind is arthrogenous muscle inhibition that inhibits alpha-motor neurons leading to decreased activation of stabilizing muscles. At molecular level, Peripheral and central sensitization contribute to LBP by releasing inflammatory mediators (substance P, bradykinin, cytokines and histamine) and by enhancing the excitability of spinal neurons respectively. Impaired neural drives alter proprioceptive feedback signals linked with increased adipose infiltration, reduced muscle quality, and diminished muscle efficiency.
In 1966, Yoshiaki Sato began developing the Kaatsu training method that has led to the current BFR training techniques that partially restrict arterial inflow. The physiologic effects of BFR at cellular level leads to activation of fast twitch muscle fibers increase in glycogen stores and protein synthesis that stimulates hypertrophy. On the molecular level, a state of localized metabolic stress due to hypoxic environment, causes an increase in growth hormone, stress-related upregulation of signaling factors and Insulin growth factor (IGF)-1 levels that improves vascular functions at low load training.
Conventional Physical Therapy leads to restoration or augmentation of the ability of neuromuscular system which is the most effective rehabilitation strategies for chronic LBP tackle the maladaptive changes in hamstring muscle morphology and function, and ranked third for improving LBP. It plays a major role in stabilizing the pelvis during trunk rotation, or when the center of gravity is grossly shifted as in CLBP. The main focus is on retraining the function of back and hip muscles by integration of exercise resulting in the fine-tuning of intersegmental motion of the spine.
Hamstring tightness leads to posterior rotation of pelvis that alters the lumbopelvic rhythm or flattening of lumbar curve subsequently increased stress on the spinal soft tissues and it may be the reason for dysfunctions that may cause CLBP. Recent literature focused on different manual and therapeutic modalities with their short-term effects on non-specific low back pain. BFR induces muscle hypertrophy and improves strength and endurance, moreover serve as a stimulus to promote protein synthesis leading to the muscle activation and integration of hamstring. BFR has been identified as an alternative when high-load resistance training is not allowed and has been extensively documented in quadriceps and upper limb muscles in literature, however its effect on hamstring remains scarcely investigated as evidence linking hamstring tightness to altered lumbopelvic mechanics and an increased risk of low back pain. This study aims to find the effect of low load blood flow restriction training on improving hamstring strength, alleviating pain and decreasing functional disability in nonspecific low back pain patients
- Conditions
- Low Back Pain
- Being tested
- Conventional PT, Low Blood Flow Restriction Training
- Keywords
- Blood Flow Restriction, Low Back Pain, hamstring muscle strength
- 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.
Conventional PTOther
All interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week. Group B will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring. Total 4 sets of each exercise (Glute bridge exercises, lumbar extension exercise, straight leg raise from prone and table top exercises) with 20 repetitions will be performed. Allow 30-60 sec rest interval
Low Blood Flow Restriction TrainingOther
All interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week. Group A will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring. For low load BFR training therapist will place sphygmomanometer cuff 10cm below the inguinal crease on the upper 3rd of thigh. The inflation pressure range will be individualized intended to produce complete arterial occlusion measured manually by palpating posterior tibial artery until the pulse will be felt no longer. Deflate the pressure cuff up to 60-80% of the AOP to create partial arterial occlusion. Total 4 sets of each exercise (Hamstring curls, Single leg hamstring curls on stability ball, standing hamstring curl, hamstring curl with sliders) with 30 repetitions in 1st set and then 15 repetitions in remaining 3 sets. Allow 30-60 sec rest interval between sets
| Study group | Role | What they receive |
|---|---|---|
| Low blood flow restriction training | Other | Low blood flow restriction training Receives: Other: Low Blood Flow Restriction Training |
| Conventional PT | Other | Conventional PT Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Muscle Testing (MMT)
MMT is the most commonly used method for documenting impairments in muscle strength. The examiner in the application of force to the subject's resistance evaluates the muscles being studied as subjectively "weak" or "strong" on a 5-point scale.
Measured: : 4 weeks
Numeric Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: 4 weeks
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of pain-related disability in persons with low back pain (LBP). The Oswestry Disability Index (ODI) addresses a broader concept of disability than that directly related to pain intensity
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 posted8 May 2026
- Study start2 May 2026
- Primary completion2 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
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
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576101
- Sponsor's protocol ID
- Muzammel Fatima
- Status last verified
- Jun 2026
- First submitted
- 4 May 2026
- Last updated
- 3 Jun 2026
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Blood Flow Restriction Training on Nonspecific Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT07576101
- Acronym / sponsor ID
- Muzammel Fatima
- Conditions
- Low Back Pain
- Keywords
- Blood Flow Restriction, Low Back Pain, hamstring muscle strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 8 May 2026 (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 randomized controlled trial is to find the effectiveness of low load blood restriction training on improving hamstring muscle strength, alleviating pain and reducing functional disability in nonspecific low back pain patients
Detailed description
Low back pain (LBP)-related disability and the related socioeconomic burden remain high despite the many treatment options and health care resources available for LBP. LBP can be caused by a specific pathology or trauma; however, in >90% of cases, an underlying disease is absent. The clinical course of this called as nonspecific LBP which is the most common type of low back pain and, some patients recover within weeks, and others experience persistent disabling symptoms leading to chronic LBP. Chronic low back pain (CLBP, pain lasting more than 12 weeks duration) is one of the most common chronic musculoskeletal disorders with high prevalence rates worldwide. Patients with CLBP have varying degrees of pain in the lumbar region of the spine, generally located between the lower ribs and the gluteal region.
Approximately 85% of patients have chronic non-specific low back pain (CNLBP) who do not have a specific patho-anatomical cause attributable to their pain in clinical examination. More than 50% of people in the United States are affected by CLBP. 90% adults will experience LBP in their lifetime, and the recurrence of LBP following chronic episode ranges from 24 to 87 %. The prevalence of LBP in children and adolescents has reaching around 39% of LBP lifetime prevalence in adults at 18 years of age. The prevalence of low back pain was 55.51% in Lahore, Pakistan.
Common nonspecific LBP symptoms include paravertebral muscle spasms, tight hamstrings, trigger points in the muscles, limited spinal range of motion, discomfort and pain. CNLBP is the most common musculoskeletal condition impacting performance leads to functional disability. Various factors associated with CLBP, including smoking, excessive BMI, poor muscle endurance, occupational ergonomic factors, poor posture, altered muscle firing rates, muscular imbalance, psychological factors as depression, inflexibility of the lower extremities, and leg length discrepancies.
Muscle tightness linked to postural disturbances and reduced extensibility resulting from increased hamstring stiffness could be a possible contributing factor to low back pain. Tight hamstring draws the pelvic into posterior rotation with greater flattening of lumbar lordosis which increase mechanical stress on the spinal soft tissues and altered hip biomechanics and lumbopelvic rhythm. If hamstrings are tight, then blood supply will be squeezed out of them leads to decreased muscle capacity, deconditioning and reduced strength which may cause abnormal changes in the bodily posture lead to lumbar hypo-lordosis causing LBP.
Chronic low back pain involves complex interaction of neuromuscular, inflammatory and neurophysiological processes that leads to constant pain. Long-term alterations in movement patterns due to muscular tightness result in structural changes within muscle fibers. The mechanism involved behind is arthrogenous muscle inhibition that inhibits alpha-motor neurons leading to decreased activation of stabilizing muscles. At molecular level, Peripheral and central sensitization contribute to LBP by releasing inflammatory mediators (substance P, bradykinin, cytokines and histamine) and by enhancing the excitability of spinal neurons respectively. Impaired neural drives alter proprioceptive feedback signals linked with increased adipose infiltration, reduced muscle quality, and diminished muscle efficiency.
In 1966, Yoshiaki Sato began developing the Kaatsu training method that has led to the current BFR training techniques that partially restrict arterial inflow. The physiologic effects of BFR at cellular level leads to activation of fast twitch muscle fibers increase in glycogen stores and protein synthesis that stimulates hypertrophy. On the molecular level, a state of localized metabolic stress due to hypoxic environment, causes an increase in growth hormone, stress-related upregulation of signaling factors and Insulin growth factor (IGF)-1 levels that improves vascular functions at low load training.
Conventional Physical Therapy leads to restoration or augmentation of the ability of neuromuscular system which is the most effective rehabilitation strategies for chronic LBP tackle the maladaptive changes in hamstring muscle morphology and function, and ranked third for improving LBP. It plays a major role in stabilizing the pelvis during trunk rotation, or when the center of gravity is grossly shifted as in CLBP. The main focus is on retraining the function of back and hip muscles by integration of exercise resulting in the fine-tuning of intersegmental motion of the spine.
Hamstring tightness leads to posterior rotation of pelvis that alters the lumbopelvic rhythm or flattening of lumbar curve subsequently increased stress on the spinal soft tissues and it may be the reason for dysfunctions that may cause CLBP. Recent literature focused on different manual and therapeutic modalities with their short-term effects on non-specific low back pain. BFR induces muscle hypertrophy and improves strength and endurance, moreover serve as a stimulus to promote protein synthesis leading to the muscle activation and integration of hamstring. BFR has been identified as an alternative when high-load resistance training is not allowed and has been extensively documented in quadriceps and upper limb muscles in literature, however its effect on hamstring remains scarcely investigated as evidence linking hamstring tightness to altered lumbopelvic mechanics and an increased risk of low back pain. This study aims to find the effect of low load blood flow restriction training on improving hamstring strength, alleviating pain and decreasing functional disability in nonspecific low back pain patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low blood flow restriction training | Other | Other: Low Blood Flow Restriction TrainingLow blood flow restriction training |
| Conventional PT | Other | Other: Conventional PTConventional PT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants falling in this category would be recruited into the study.
- Both gender
- Age is between 18-45 years
- Individuals with pain localized posteriorly below the costal margin and above the inferior gluteal folds for more than 12 weeks
- A score greater than or equal to 4/10 on Numeric Pain Rating Scale (NPRS)
Key exclusion criteria (8 listed)
- Participants falling in this category would be excluded from the study.
- Patients of spinal stenosis, disc herniation spondylolisthesis, spondylosis or osteoporosis will be excluded
- Participants had a history of hip or lower extremity pathology requiring medical or surgical intervention.
- History of venous thromboembolism (VTE), clotting or other hematologic disorder
- Peripheral arterial disease, hypertension (blood pressure >140/90 mm Hg), coronary artery disease
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 |
|---|---|---|
| Conventional PTAll interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week. Group B will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring. Total 4 sets of each exercise (Glute bridge exercises, lumbar extension exercise, straight leg raise from prone and table top exercises) with 20 repetitions will be performed. Allow 30-60 sec rest interval | Other | Conventional PT |
| Low Blood Flow Restriction TrainingAll interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week. Group A will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring. For low load BFR training therapist will place sphygmomanometer cuff 10cm below the inguinal crease on the upper 3rd of thigh. The inflation pressure range will be individualized intended to produce complete arterial occlusion measured manually by palpating posterior tibial artery until the pulse will be felt no longer. Deflate the pressure cuff up to 60-80% of the AOP to create partial arterial occlusion. Total 4 sets of each exercise (Hamstring curls, Single leg hamstring curls on stability ball, standing hamstring curl, hamstring curl with sliders) with 30 repetitions in 1st set and then 15 repetitions in remaining 3 sets. Allow 30-60 sec rest interval between sets | Other | Low blood flow restriction training |
Primary outcome
Manual Muscle Testing (MMT)
Time frame: : 4 weeks
MMT is the most commonly used method for documenting impairments in muscle strength. The examiner in the application of force to the subject's resistance evaluates the muscles being studied as subjectively "weak" or "strong" on a 5-point scale.
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks
The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Oswestry Disability Index (ODI)
Time frame: 4 weeks
The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of pain-related disability in persons with low back pain (LBP). The Oswestry Disability Index (ODI) addresses a broader concept of disability than that directly related to pain intensity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
KINZA ANWAR, MS-OMPT 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 Conventional PT and Low Blood Flow Restriction Training in people with Low Back Pain, 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KINZA ANWAR, MS-OMPT (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Muscle Testing (MMT) (time frame: : 4 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?
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 3 Jun 2026.