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Not yet recruiting NCT06586450

Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low level laser therapy, Interferential current, Core stability exercise.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: 50 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Device Low level laser therapy
    The participants will receive Low Level Laser on lumbo-pelvic region for 20 min/sessions,3 sessions / week for 12 weeks, with the following parameters: Wavelength: 808 nm, continuous mode, Output power: 160 mw, Penetration depth: 4 cm, Power density:0.16 J/cm2.
  • Device Interferential current
    All participants will receive interferential current on lumbopelvic region ( quadripolar technique) for 25 min/session, 3 sessions/week for 12 weeks, with the following parameters: carrier frequency of 4 KHZ and sweep frequency 95 HZ, intensity based on patient's tolerance without muscle contraction.
  • Other Core stability exercise
    The participants will perform core stability exercises for 15 min 3 time/week in the form of Prone Gluteal Squeezes, Pelvic Bridging, Curl Up Exercise, and Double Knee to Chest Stretching Exercises.

Primary outcome measures

  • Pain severity [Time frame: 12 weeks]
  • Lumbar flexion range of motion [Time frame: 12 weeks]
  • Lumbar extension range of motion [Time frame: 12 weeks]
  • Lumbar lateral flexion range of motion [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Functional disability [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ola Saad El Naggar — Alexandria

Identifiers

NCT: NCT06586450 · P.T.REC/012/005317

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗