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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03961477
Other study ID # P.T REC/012/001811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2017
Est. completion date September 23, 2018

Study information

Verified date May 2019
Source Ahlia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Chronic non-specific low back pain is defined as unknown mechanical musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic, non-invasive and simple method back pain treatment that is mainly applied using interferential (IF) therapy. The current study was designed to investigate the effect of IF on pain, range of motion, and quality of life in patients with chronic non-specific low back pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion& extension and the Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).


Description:

Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60 patients (29 males and 31 females) were invited to participate in the current study. Subjects were included in the study if they had LBP of at least three months duration and aged between 25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last eight weeks or any contraindications to the use of electrotherapy were excluded.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 23, 2018
Est. primary completion date July 11, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria:

*Subjects were included in the study if they had LBP of at least three months duration * Age between 25 and 60 years.

Exclusion Criteria:

- Patients with spinal pathology (tumor, nerve root, fracture, and compromise),

- Cardiopulmonary conditions

- Pregnancy,

- Received physiotherapy in the last eight weeks

- Any contraindications to the use of electrotherapy were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interferential therapy
Exercise therapy

Locations

Country Name City State
Egypt Dr Dalia Kamel Giza
Egypt Dr Sayed Tanatwy Giza

Sponsors (2)

Lead Sponsor Collaborator
Ahlia University Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) The severity of pain was evaluated using a visual analogue scale (VAS). The participants were requested to put a line on the scale perpendicularly that matched to their pain intensity. VAS scores represent the pain intensity as none, mild, moderate, or severe. The accompanying cutoff was used for the pain scale: 0- 4 , no pain; 5- 44, mild pain; 45- 74, moderate pain; and 75-100, severe pain 6 months
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