The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial
Primary Purpose
Low Back Pain, Mechanical
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
mobilization
manual therapy
instrumental manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical
Eligibility Criteria
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).
Sites / Locations
- Imam Abdulrahman Bin Faisal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
manual therapy
instrumental manual therapy
Arm Description
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.
the intervention groub rcieved central postero-anterior mobilization with a force of 20-30 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine.
Outcomes
Primary Outcome Measures
Numeric pain rating scale
a series of numbers from 0 to 10, with '0' indicating no pain and '10' indicating the most intense pain possible
Lumbar Multifidus muscle activation
muscle activation quantified by measuring the muscle thickness during rest and activation positions.
Secondary Outcome Measures
Pressure pain threshold
measured 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 ROM
measured in flexion, extension, and lateral flexion to both sides. Dual inclinometer method used to take the measurements (Baseline Bubble Inclinometer device)
Full Information
NCT ID
NCT04367376
First Posted
April 26, 2020
Last Updated
April 28, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT04367376
Brief Title
The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial
Official Title
The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
instrumental manual therapy
Arm Type
Experimental
Arm Description
the intervention groub rcieved central postero-anterior mobilization with a force of 20-30 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine.
Intervention Type
Other
Intervention Name(s)
mobilization
Intervention Description
central postroanterion mobilization on the most painful vertebral level at the lumbar spine
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
manual therapy
Intervention Type
Other
Intervention Name(s)
instrumental manual therapy
Intervention Description
instrumental manual therapy
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
a series of numbers from 0 to 10, with '0' indicating no pain and '10' indicating the most intense pain possible
Time Frame
2-3 weeks
Title
Lumbar Multifidus muscle activation
Description
muscle activation quantified by measuring the muscle thickness during rest and activation positions.
Time Frame
2-3 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
measured 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
Time Frame
2-3 weeks
Title
Lumbar spine ROM
Description
measured in flexion, extension, and lateral flexion to both sides. Dual inclinometer method used to take the measurements (Baseline Bubble Inclinometer device)
Time Frame
2-3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Khobar
State/Province
Eastern
ZIP/Postal Code
31911
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qassem Almuaidi, Dean
Phone
+966550033666
Email
qmuaidi@iau.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial
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