CClinicalTrials.gg
CompletedNCT03511404LBPUpdated Apr 16, 2019

Clinical Electrophysiology Assessment for Low Back Pain

An interventional study of physiotherapy rehabilitation in Non Specific Chronic Low Back Pain, sponsored by The University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Oct 2015, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Non Specific Chronic Low Back Pain

Keywords

  • Non specific chronic low back pain
  • surface electromyography (EMG)
  • neuromuscular function
  • physiotherapy
  • Numeric Pain Rating Scale
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Chronical LBP

    Patients with chronic low back pain to be measured with Numeric Pain Rating Scale (NPRS).

    Other: physiotherapy rehabilitation

Interventions

  • Otherphysiotherapy rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline on enrollment and after six weeks physiotherapy

Secondary outcomes

  1. 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.

    Time frame: Baseline on enrollment and after six weeks physiotherapy

07

Study locations

1 site
  • Electromyography (EMG)system
    Zhuhai, Guangdong 519085, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03511404
Lead sponsor
The University of Hong Kong
Collaborators
The Queen Elizabeth Hospital
Responsible party
Dr. Yong HU (Associate Professor, The University of Hong Kong) — Principal investigator
First posted
Apr 27, 2018
Start date
Oct 1, 2015
Primary completion
Dec 31, 2018
Completion
Mar 31, 2019
Last update
Apr 16, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion