NCT07448766

Brief Summary

The goal of this study is to train core muscles in patients with chronic low back pain, the researchers will compar between the effect of suspension exercise core muscle training and pressure biofeed back core muscle training

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 19, 2026

Last Update Submit

March 1, 2026

Conditions

Keywords

chronic low back paincore musclespressure biofeedback trainingsuspension exercises

Outcome Measures

Primary Outcomes (2)

  • change of low back pain

    Low back pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). Participants will be instructed to select the number that best represents their current pain intensity. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity.

    one month

  • Change in Lumbar Extension Range of Motion

    Lumbar extension range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).

    one month

Secondary Outcomes (8)

  • Change in Lumbar Flexion Range of Motion

    one month

  • Change in Trunk Flexor Muscle Endurance

    one month

  • Change in Trunk Extensor Muscle Endurance

    one month

  • Change in Right Lateral Trunk Muscle Endurance

    one month

  • Change in Left Lateral Trunk Muscle Endurance

    one month

  • +3 more secondary outcomes

Study Arms (3)

suspension training group

ACTIVE COMPARATOR

this group will recieve training of the core muscle of the low back with suspension exercises

Behavioral: suspension execises

pressure biofeedback training group

ACTIVE COMPARATOR

This group will recieve training of core muscle of the low back with pressure biofeedback device

Behavioral: pressure biofeedback training

control group

PLACEBO COMPARATOR

this group will recieve advices about low back pain

Behavioral: advices

Interventions

Participants were instructed to perform the exercises through the full range of motion using the correct technique, while maintaining a neutral alignment of the spine and pelvis throughout each movement. Each exercise was performed three times, with each repetition lasting six seconds. A three-minute rest interval was provided between exercises to ensure adequate recovery, all exercises were performed three times per week for a duration of four weeks The following exercises have been selected 1. Roll-out 2. Bodysaw 3. Pike 4. Knee-tuck

suspension training group

The patients were instructed to take a relaxed breath in and out, hold the breath out, and then draw in the lower abdomen without moving the spine. Independent contraction of the transversus abdominis muscle was achieved through the abdominal drawing-in maneuver(ADIM). * In the supine position, the pressure biofeedback unit was placed beneath the lumbar lordosis, and air was infused into the bulb to establish a baseline pressure of 40 mmHg. pressure increases of 0-2 mmHg g from a baseline of 40 mmHg * In the prone position, the pressure biofeedback unit was positioned between the navel and the anterior superior iliac spine (ASIS), and air was infused into the bulb to establish a baseline pressure of 70 mmHg. A decrease in pressure ranging from 4 to 10 mmHg during the performance of the active drawing-in maneuverwas considered to indicate a successful execution of the exercise. * After two weeks, lumbar stabilization exercises were progressively introduced

pressure biofeedback training group
advicesBEHAVIORAL

1. Participants are instructed to walk as normally and flexibly as possible 2. Advise when lifting: * Participants are instructed to avoid twisting and bending. * When lifting heavy objects, they are instructed to use their thighs while keeping the back vertical. * At other times, they are instructed to use the back and flex it appropriately. 3. Participants were instructed to apply heat for 20 minutes, twice daily 4. Avoid sitting or standing for prolonged period and change position every 15 minutes. 5. Sitting: Sit with a back support 6. Driving: Use a back support (lumbar roll) at the curve of your back. 7. Participants were instructed to sleep and lie down on a firm mattress and box spring set that did not sag. If necessary, they were advised to place a board under the mattress or temporarily position the mattress on the floor.

control group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Forty-eight male and female CNLBP patients were included in this study. 2. Their age ranged from 20 to 35 years. 3. Patients complained of pain and discomfort in the lumbosacral and buttock region, lasting from 3 to 24 months.

You may not qualify if:

  • Discogenic patients with or without radiculopathy.
  • Underlying disease such as malignancy.
  • Viscerogenic causes of back pain, pregnancy.
  • Infection or systemic disease of musculoskeletal system.
  • Sensory disturbance.
  • Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolysis, spondylolisthesis, ankylosing spondylitis, or sacroiliitis.
  • Neuromuscular diseases like multiple sclerosis or dermatologic disease that involves the lumber and abdominal area, contractures.
  • History of previous back surgery or trauma.
  • BMI ≥ 25 to avoid effect of obesity.
  • Post menopause females to exclude post menopause hormonal changes.
  • Metabolic diseases such as diabetes and hypothyroidism, coagulopathies (such as hemophilia).
  • Usage of anticoagulants, febrile state; or anyone who had used coffee or tobacco 24 hours before the study evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eman R Aboturky, MSc

    Cairo University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at orthopedic department, faculty of physical therapy

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 4, 2026

Study Start

September 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 25, 2025

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

"Data from this study will not be shared to protect participant privacy and comply with ethical approvals."

Locations