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

NCT ID: NCT06586450

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-01-15

Brief Summary

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

Detailed Description

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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

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low level laser group

The participants will receive low level laser therapy and core stability exercises

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type DEVICE

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.

Core stability exercise

Intervention Type OTHER

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.

Interferential current group

The participants will receive interferential current and core stability exercises

Group Type EXPERIMENTAL

Interferential current

Intervention Type DEVICE

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.

Core stability exercise

Intervention Type OTHER

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.

Core stability exercise group

The participants will perform core stability exercises only

Group Type ACTIVE_COMPARATOR

Core stability exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ola Saad Ibrahim El-Naggar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azza B Kassab, professor

Role: STUDY_CHAIR

Cairo University

Locations

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Ola Saad El Naggar

Alexandria, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ola S El-Naggar, Master

Role: CONTACT

+201022105583

Mohamed F Abo Eleinien, PHD

Role: CONTACT

+201001414404

Other Identifiers

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P.T.REC/012/005317

Identifier Type: -

Identifier Source: org_study_id

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