Low Back PainyesNCT07892079
Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)
A study of Low Back Pain, run by University of Management and Technology Lahore at 1 site in Pakistan.
Trial summary
This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving Transversus abdominis (TrA) muscle activation, and decreasing… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2026to 31 Dec 2026
- Phase
- Interventional
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
- Recurrent LBP patients aged ≥ 18 to 45 years old. Both genders. Mild to moderate back pain with NPRS pain score value of between 3-6. At least 2 episodes of pain in the past 12 months, each episode lasting for 24 hours. No radiating pain below the gluteal fold. Patient able to perform ADIM.
Who cannot join
- Specific LBP attributable to identifiable pathology: fracture, malignancy, infection, inflammatory arthropathy Active lumbar radiculopathy with neurological deficit (sensory loss, motor weakness, or reflex changes in the lower limbs). Any referred pain below gluteal fold or neurological involvement in lower limbs is not included. Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolisthesis, and spondylitis and other medical illnesses such as tumor, kidney disease, and visceral disease that can be related with low back pain excluded in this study. Participants who had undergone surgery for LBP in past 12 months. Pregnancy. Current participation in other physiotherapy or rehabilitation program
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
University of Management & Technology
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Motor Control With and Without Pressure Biofeedback-Guided Training on Pain, Transversus Abdominis Activation and Disability in Patients With Recurrent Low Back Pain.
This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving Transversus abdominis (TrA) muscle activation, and decreasing disability. The study will determine whether adding pressure biofeedback to motor control exercises provides better clinical outcomes than motor control exercises alone.
- Conditions
- Low Back Pain
- Being tested
- Motor Control Exercise with Pressure Biofeedback-Guided Training, Motor Control Exercise
- Keywords
- Motor control exercise, Revised Oswestry Disability Index., Pressure biofeedback, Transversus Abdominis, Recurrent Low Back Pain
- 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.
Motor Control Exercise with Pressure Biofeedback-Guided TrainingOther
Participants will receive 45-minute sessions comprising a 5-minute warm-up, 35-minute Motor Control Exercises (MCE), and 5-minute cool-down, guided by Pressure Biofeedback (PBU).
Weeks 1-2: ADIM, diaphragmatic breathing, multifidus activation, and heel slides (2-3 sets × 10 repetitions).
Weeks 3-4: Straight leg raises, double-leg lowering, bridging, and quadruped arm/leg extensions (3 sets × 8-10 repetitions).
Weeks 5-6: Standing ADIM, partial squats, planks, and sit-to-stand exercises (3 sets × 10 repetitions; planks 20-45 seconds).
Motor Control ExerciseOther
Participants will receive the same 45-minute Motor Control Exercise (MCE) program as in experimental group, including warm-up, phased exercises (Weeks 1-6), and cool-down, with identical sets, repetitions, hold times, rest intervals, and progression criteria, but without Pressure Biofeedback (PBU). Standardized verbal instructions and tactile cues (TrA palpation) will guide muscle activation. The same physiotherapist will supervise both groups, with exercise completion and adverse events recorded in session logs.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control Training with Pressure Bio-feedback | Experimental | Not described Receives: Other: Motor Control Exercise with Pressure Biofeedback-Guided Training |
| Motor Control Training | Active comparator | Not described Receives: Other: Motor Control Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain
Measured: Baseline, 3 weeks and after 6 weeks post treatment
REVISED OSWESTERY DISABILITY QUESTIONNAIRE (RODQ)
The Revised Oswestry Disability Questionnaire (RODQ) is a valid and reliable 10-item questionnaire. Each item is scored 0-5, with total disability expressed as a percentage: 0-20% (minimal), 21-40% (moderate), 41-60% (severe), 61-80% (crippled/severe functional limitation), and 81-100% (very severe disability). Higher scores indicate greater disability.
Measured: Baseline, 3 weeks and after 6 weeks post treatment
REHABILITATIVE ULTRASOUND IMAGING (RUSI)
Rehabilitative Ultrasound Imaging (RUSI) is a non-invasive, reliable technique used to assess deep trunk muscle morphology, thickness, and activation. Transversus Abdominis (TrA) activation will be evaluated by measuring muscle thickness at rest and during contraction. Changes in muscle thickness will serve as an indirect indicator of muscle activation and lumbopelvic stability.
Measured: Baseline, 3 weeks and after 6 weeks post treatment
PRESSURE BIOFEEDBACK
The Pressure Biofeedback Unit (PBU) is a non-invasive device consisting of an inflatable pressure cell and gauge that provides visual feedback to improve lumbopelvic control during motor control exercises. It helps enhance abdominal muscle recruitment, reduce lumbopelvic instability, and improve movement control in patients with chronic low back pain.
Measured: Baseline, 3 weeks and after 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Model description
- This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving transversus abdominis muscle activation, and decreasing functional disability. Muscle activation will be assessed using real-time ultrasound imaging, while disability will be measured using the Revised Oswestry Disability Index. The study will determine whether adding pressure biofeedback to motor control exercises provides better clinical outcomes than motor control exercises alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Management and Technology Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salman Bashir, University of Management and Technology Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892079
- Sponsor's protocol ID
- RE-167-2026
- Acronym
- yes
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes