Clinical trial NCT06586450: Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain
Official title: Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain.

Detailed description: Low back pain (LBP) is a major health problem affecting majority of the people at some point of their life.The prevalence of postmenopausal LBP is 32.4%. It has major implication for quality of life, such as limitation of daily activities and physiological stress, being one of the main causes of work absenteeism.

The prolonged use of NSAIDs is associated with cardiovascular, hepatic, and renal problems. Therefore, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy to relieve postmenopausal LBP.

Low level laser has been proven to have an impact on postmenopausal LBP, through several mechanisms as (a) increased endogenous opioid neurotransmitter production ;(b)raised threshold to thermal pain and enhanced local blood circulation ; (c)increased oxygen consumption by accelerating the redox reaction rate of the electron respiratory chain of mitochondria ; (d) increased adenosine triphosphate (ATP) production at the cellular level ;(e) increased production of the anti-inflammatory cytokines.

Also, another non- invasive technique is the interferential current which is one of the existing electrotherapy treatments used to reduce pain and has been studied for its effectiveness in relieving LBP through its deeper penetration into the tissues.

So, this study will be conducted to provide new evidence and information about the efficacy of low-level laser versus interferential current on LBP in postmenopausal women

Eligibility criteria: Inclusion Criteria:

• Sixty postmenopausal women (at least one year after stoppage menses).

* Their age will be ranged from 50 to 60 years.
* Their body mass index (BMI) will be less than 30 kg/m2.
* All of them suffer from chronic low back pain (at least 3 months).
* The score of pain will be 2 or more according to visual analogue scale (VAS).

Exclusion Criteria:

* Spinal fracture or any other neurological disorder.
* Lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
* BMI\>30 kg/m2
* Gynecological Diseases as Chronic pelvic pain or genital prolapse.

Primary outcomes:
measure: Pain severity
timeFrame: 12 weeks
measure: Lumbar flexion range of motion
timeFrame: 12 weeks
measure: Lumbar extension range of motion
timeFrame: 12 weeks
measure: Lumbar lateral flexion range of motion
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional disability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ola Saad El Naggar
Study officials:
affiliation: Cairo University
name: Azza B Kassab, professor
role: STUDY_CHAIR
References: