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The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial

The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04367376
Enrollment
40
Registered
2020-04-29
Start date
2020-06-01
Completion date
2021-04-30
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Mechanical

Brief summary

Objectives: To investigate the effectiveness of instrument-based mobilization compared with manual mobilization in patients with non-specific low back pain (NLBP), in terms of spinal muscle activation, decrease in pain, and improvement in range of motion (ROM). Design: Randomized clinical trial, double blind. Participants and interventions: A total of 66 participants with localized NLBP will be divided into 2 groups matched for sex, age, and body mass index. The intervention group will receive central postero-anterior mobilization with a force of 150 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine. The control group will receive central postero-anterior grade III mobilization through the pisiform grip method at the level of pain in the lumbar spine. Main outcome measures: Measurements will be taken before the intervention, after the 1st session, after the 6th session, and at 4 weeks follow-up. Rehabilitative ultrasound imaging will be done to identify lumbar multifidus (LM) activation through the measurement of muscle thickness at the level of L5-L4 vertebrae, during rest and lower-extremity movement. Each participant will self-rate the pain intensity in the lumbar spine according to the Numeric Pain Rating Scale (NPRS). The pressure-pain threshold (PPT) will be measured using an algometer. Lumbar ROM will be measured using a dual inclinometer method in flexion and extension. The results will be compared between the intervention and control groups through mixed analysis of variance for LM thickness, lumbar ROM, PPT, and NPRS.

Interventions

instrumental manual therapy

OTHERmobilization

central postroanterion mobilization on the most painful vertebral level at the lumbar spine

OTHERmanual therapy

manual therapy

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* age 20-59 years (commonly affected age range), BMI 18.5-30 kg/m2 (normal to overweight), localized NLBP, pain duration \<12 months, and pain score ≥3/10 on the NPRS.

Exclusion criteria

* history of spinal surgery, significant previous back trauma, spinal or lower-extremity deformities, LBP associated with peripheral neurological symptoms (paraesthesia, anaesthesia, signs of nerve root compression), neurological diseases, systemic diseases (diabetes mellitus, rheumatoid arthritis), and any contraindication to manual therapy (spinal instability, healing fracture, dislocations, pregnancy in women).

Design outcomes

Primary

MeasureTime frameDescription
Numeric pain rating scale2-3 weeksa series of numbers from 0 to 10, with '0' indicating no pain and '10' indicating the most intense pain possible
Lumbar Multifidus muscle activation2-3 weeksmuscle activation quantified by measuring the muscle thickness during rest and activation positions.

Secondary

MeasureTime frameDescription
Pressure pain threshold2-3 weeksmeasured at the most painful site on the back as well as on a mid-point at RT tibialis anterior muscle belly lateral to the tibia
Lumbar spine ROM2-3 weeksmeasured in flexion, extension, and lateral flexion to both sides. Dual inclinometer method used to take the measurements (Baseline Bubble Inclinometer device)

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026