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

NCT06586450 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005317
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Pain severity

  The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain

  12 weeks

• Lumbar flexion range of motion

  The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).

  12 weeks

• Lumbar extension range of motion

  The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1cm should be considered abnormal).

  12 weeks

• Lumbar lateral flexion range of motion

  The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.

  12 weeks

Secondary Outcomes (1)

• Functional disability

  12 weeks

Study Arms (3)

Low level laser group

EXPERIMENTAL

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

Device: Low level laser therapy; Other: Core stability exercise

Interferential current group

EXPERIMENTAL

The participants will receive interferential current and core stability exercises

Device: Interferential current; Other: Core stability exercise

Core stability exercise group

ACTIVE COMPARATOR

The participants will perform core stability exercises only

Other: Core stability exercise

Interventions

Low level laser therapy 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.

Low level laser group

Interferential current 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.

Interferential current group

Core stability exercise 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; Interferential current group; Low level laser group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ola Saad El Naggar

Alexandria, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Low-Level Light Therapy; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Azza B Kassab, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ola S El-Naggar, Master

CONTACT

+201022105583; olaelnaggar2018@gmail.com

Mohamed F Abo Eleinien, PHD

CONTACT

+201001414404; drmohamedfawzy61@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: December 10, 2024
• Study Completion: January 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)