Back to resultsClinical Electrophysiology Assessment for Low Back Pain (LBP)
Primary Purpose
Non Specific Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
physiotherapy rehabilitation
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Specific Chronic Low Back Pain focused on measuring Non specific chronic low back pain, surface electromyography (EMG), neuromuscular function, physiotherapy, Numeric Pain Rating Scale
Eligibility Criteria
Inclusion Criteria:
- One hundred persons with non specific low back pain will be recruited consecutively from the Specialist Outpatient Department (SOPD) of Physiotherapy Department of Queen Elizabeth Hospital. Subjects will be included in the study if they presented with symptom duration of greater than three months with no radiological abnormality detected.
Exclusion Criteria:
- All subjects should be able to provide informed consent and demonstrate sufficient ability to tolerate the experiment procedure to avoid aggravation of symptoms during the experiment procedures. Subjects will be excluded if they have any major orthopedic, neurological, circulatory or respiratory conditions, a history or family history of epilepsy, recent or current pregnancies, and previous surgery to the abdomen or back. The back pain history in the previous year will be documented for those eligible subjects.
Sites / Locations
- Electromyography (EMG)system
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chronical LBP
Arm Description
Patients with chronic low back pain to be measured with Numeric Pain Rating Scale (NPRS).
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
Intensity of self-reported pain was measured using a Numeric Pain Rating Scale (NPRS) anchored with 'no pain' at 0 and 'worst pain imaginable' at 10. Subjects rated their average pain over the preceding month prior to motor training, and rated their average pain across the final week of motor training.
Secondary Outcome Measures
surface electromyography (EMG)
Disposable surface EMG electrodes will be attached in array to the right and left lumbar erector spinae (LES) muscles, approximately 2 cm lateral to the L3 spinous process. Root mean square amplitude of surface EMG measured was calculated and flexion-relaxation ratio in sitting was formulated by dividing the average surface EMG activity in upright sitting by the average surface EMG activity in slumped sitting.
Full Information
NCT ID
NCT03511404
First Posted
April 17, 2018
Last Updated
April 15, 2019
Sponsor
The University of Hong Kong
Collaborators
The Queen Elizabeth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03511404
Brief Title
Clinical Electrophysiology Assessment for Low Back Pain
Acronym
LBP
Official Title
Clinical Electrophysiology Assessment for Rehabilitation Progress of Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
The Queen Elizabeth Hospital
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
Non specific chronic low back pain (LBP) is a debilitating disorder characterized by tremendous personal and socioeconomic impact, with long-term sick leave, low quality of life, and very high financial costs. Evidence suggests that patients with non specific LBP presented with altered muscle activity pattern when compare with healthy people. It has been reviewed that exercise therapy was effective for modulation of muscle dysfunction in chronic low back pain. However, there is a lack of objective assessment of the pain relief in low back pain rehabilitation. Clinical application of surface electromyography (EMG) may provide a quantitative and objective tool to evaluate the rehabilitation outcome in patients with non specific chronic low back pain before and after treatment.
Objectives: To verify the usefulness of surface electromyography (EMG) in low back pain (LBP) rehabilitation assessment.
Setting: Out-patient physiotherapy musculoskeletal rehabilitation
Detailed Description
Participants: One hundred adults with non specific chronic low back pain (LBP) will be recruited.
Methodology: A prospective correlation study between clinical examination and electrophysiology assessment. This project will perform carefully with a definitive chronic low back pain (LBP). Firstly, we will compare the surface EMG features from patients with LBP to normal data. In addition, the changes in electrophysiology assessment will be compared with clinical assessment by Numeric Pain Rating Scale (NPRS). This allows us to verify the potential clinical application of surface EMG features in physiotherapy progress assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Chronic Low Back Pain
Keywords
Non specific chronic low back pain, surface electromyography (EMG), neuromuscular function, physiotherapy, Numeric Pain Rating Scale
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A correlation study between clinical examination by Numeric Pain Rating Scale (NPRS) and electrophysiology assessment by surface EMG will be conducted at enrollment and 6 weeks physiotherapy.
Masking
None (Open Label)
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronical LBP
Arm Type
Experimental
Arm Description
Patients with chronic low back pain to be measured with Numeric Pain Rating Scale (NPRS).
Intervention Type
Other
Intervention Name(s)
physiotherapy rehabilitation
Intervention Description
All subjects will receive a course of conventional physiotherapy that incorporating components of pain relief and functional restoration with the use of electrotherapy and exercise therapy for twelve sessions twice weekly in six weeks guided by a registered physiotherapist in Hong Kong.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Intensity of self-reported pain was measured using a Numeric Pain Rating Scale (NPRS) anchored with 'no pain' at 0 and 'worst pain imaginable' at 10. Subjects rated their average pain over the preceding month prior to motor training, and rated their average pain across the final week of motor training.
Time Frame
Baseline on enrollment and after six weeks physiotherapy
Secondary Outcome Measure Information:
Title
surface electromyography (EMG)
Description
Disposable surface EMG electrodes will be attached in array to the right and left lumbar erector spinae (LES) muscles, approximately 2 cm lateral to the L3 spinous process. Root mean square amplitude of surface EMG measured was calculated and flexion-relaxation ratio in sitting was formulated by dividing the average surface EMG activity in upright sitting by the average surface EMG activity in slumped sitting.
Time Frame
Baseline on enrollment and after six weeks physiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
One hundred persons with non specific low back pain will be recruited consecutively from the Specialist Outpatient Department (SOPD) of Physiotherapy Department of Queen Elizabeth Hospital. Subjects will be included in the study if they presented with symptom duration of greater than three months with no radiological abnormality detected.
Exclusion Criteria:
All subjects should be able to provide informed consent and demonstrate sufficient ability to tolerate the experiment procedure to avoid aggravation of symptoms during the experiment procedures. Subjects will be excluded if they have any major orthopedic, neurological, circulatory or respiratory conditions, a history or family history of epilepsy, recent or current pregnancies, and previous surgery to the abdomen or back. The back pain history in the previous year will be documented for those eligible subjects.
Facility Information:
Facility Name
Electromyography (EMG)system
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519085
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Electrophysiology Assessment for Low Back Pain
We'll reach out to this number within 24 hrs