Effect of Interferential l Therapy on Low Back Pain

NCT03961477 | Completed DMC

• 1 other identifier: P.T REC/012/001811
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Low Back Pain

Keywords

Low Back Pain,; Interferential Therapy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IF group

ACTIVE COMPARATOR

Interferential therpapy

Other: Interferential therapy

Placebo

NO INTERVENTION

No intervention

Interventions

Interferential therapy OTHER

Exercise therapy

Also known as: Exercise therapy

IF group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahlia University: lead
• Cairo University: collaborator

Study Sites (2)

Dr Dalia Kamel

Giza, Egypt

Location

Dr Sayed Tanatwy

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Electric Stimulation Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Sayed A Tantawy, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each subject in both groups was positioned in prone lying and the area to be treated was exposed. The IF group which included 30 subjects received IF. The IF current was increased gradually according the subject's condition with comfortable tingling sensation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: December 5, 2017
• Primary Completion: July 11, 2018
• Study Completion: September 23, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

EG (2)