NCT07480759

Brief Summary

his randomized clinical trial aims to compare the effects of low-load blood flow restriction (LL-BFR) training and traditional heavy-load resistance training (HL-RT) on male athletes with sub-acute non-specific low back pain. Participants will be randomly assigned to either the LL-BFR or HL-RT group for a specified intervention period. Both groups will perform supervised exercise sessions targeting core and lumbar stabilizing muscles. Outcomes including pain intensity, functional disability, and muscle strength will be assessed at baseline and post-intervention. The study seeks to determine whether LL-BFR can provide comparable or superior benefits to HL-RT while reducing mechanical stress on the lumbar spine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 10, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

November 17, 2025

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS) for Pain Intensity in Sub-Acute Non-Specific Low Back Pain

    Pain intensity in participants with sub-acute non-specific low back pain will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will be asked to rate their average low back pain during the past 24 hours by selecting a number from 0 to 10.

    Baseline and 4 weeks

Study Arms (2)

Low Load Blood Flow Restriction Training (LL-BFR)

EXPERIMENTAL
Other: Low Load Blood Flow Restriction Training (LL-BFR)Other: Traditional Heavy Load Resistance Training (HL-RT)

Traditional Heavy Load Resistance Training (HL-RT)

ACTIVE COMPARATOR
Other: Low Load Blood Flow Restriction Training (LL-BFR)Other: Traditional Heavy Load Resistance Training (HL-RT)

Interventions

Participants will perform low-load resistance exercises with elastic occlusion cuffs on the proximal thighs, combined with four core exercises (Glute Bridge, Wall Sit, Step-Ups, Bird-Dog). Sessions last 50 minutes, three times per week for 4 weeks. Exercise intensity starts at 20% of 1RM and progresses to 35%, with sets and repetitions designed to improve core strength, reduce pain, and enhance spinal stabilization.

Low Load Blood Flow Restriction Training (LL-BFR)Traditional Heavy Load Resistance Training (HL-RT)

Participants will perform high-load resistance exercises without occlusion cuffs, using the same four core exercises. Sessions last 55 minutes, three times per week for 4 weeks. Intensity starts at 50% of 1RM and progresses to 75-80%, with sets and repetitions aimed at improving muscle strength, core stability, and reducing pain and functional disability.

Low Load Blood Flow Restriction Training (LL-BFR)Traditional Heavy Load Resistance Training (HL-RT)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male athletes (Liu et al., 2025)
  • Age 18-24 years (Liu et al., 2025)
  • Athletes like wrestlers, weightlifters and sprinters
  • Report pain and discomfort localized below the costal margin and above the inferior gluteal folds. (Adhikari et al., 2021)
  • Subacute low back pain - Pain lasting between 4 to 12 weeks. (Chou \& Atlas, 2023)
  • Participants with moderate level of pain on Visual analogue scale.(Nambi et al., 2022)
  • Negative straight-leg-raising (SLR) test, which is useful for diagnosing lumbar disc herniation. (Jardim et al., 2022)
  • No dominant leg pain from radicular or cauda equina disorders. (Liu et al., 2025)
  • No history of previous lumbar or thoracolumbar spine surgery. (Jardim et al., 2022)

You may not qualify if:

  • Any prior lumbar or thoracolumbar spine surgery (Liu et al., 2025)
  • A history of cancer, spinal infection, rheumatologic diseases, spine fracture, red flag signs (such as significant and unexplained weight loss exceeding 10% of total body weight within the past six months, and presence of fever), psychological disorders, and previous spine surgery, radiculopathy, anatomical or congenital abnormalities. (Hernandez-Lucas et al., 2023)
  • History of peripheral arterial disease or deep vein thrombosis. (Jardim et al., 2022)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIPT, UOL, Lahore

Lahore, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2025

First Posted

March 18, 2026

Study Start

November 10, 2025

Primary Completion

February 10, 2026

Study Completion

February 10, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations