Clinical Electrophysiology Assessment for Low Back Pain

NCT03511404 | Completed

• 1 other identifier: 15-0132
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Non Specific Chronic Low Back Pain

Keywords

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

Outcome Measures

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.

  Baseline on enrollment and after six weeks physiotherapy

Secondary Outcomes (1)

• surface electromyography (EMG)

  Baseline on enrollment and after six weeks physiotherapy

Study Arms (1)

Chronical LBP

EXPERIMENTAL

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

Other: physiotherapy rehabilitation

Interventions

physiotherapy rehabilitation OTHER

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.

Chronical LBP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

Electromyography (EMG)system

Zhuhai, Guangdong, 519085, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: October 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CN (1)