NCT07576101

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

Study Start

First participant enrolled

May 2, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Blood Flow RestrictionLow Back Painhamstring muscle strength

Outcome Measures

Primary Outcomes (3)

  • 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.

    : 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.

    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

    4 weeks

Study Arms (2)

Low blood flow restriction training

OTHER

Low blood flow restriction training

Other: Low Blood Flow Restriction Training

Conventional PT

OTHER

Conventional PT

Other: Conventional PT

Interventions

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

Conventional PT

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

Low blood flow restriction training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute Of Rehabilitation Medicine G-8/2, Islamabad

Islamabad, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KINZA ANWAR, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KINZA ANWAR, MS-OMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

May 2, 2027

Study Completion (Estimated)

May 12, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations