Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

NCT04970199 | Completed

• 1 other identifier: P.T.REC/012/003252
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic lupus erythematosus is a chronic and multisystemic autoimmune disorder which predominantly affecting women. The most common cause of death in lupus patients affected by disease for more than 5 years is cardiovascular disease due to presence of some factors as oxidative stress, pro-inflammatory cytokines , dyslipidemia, diabetes, and hypertension.

Conditions

System; Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Malondialdehyde

  anti-oxidative stress factor

  It was measured after 4 weeks

Secondary Outcomes (9)

• systole

  It was measured after 4 weeks

• diastole

  It was measured after 4 weeks

• blood glucose

  It was be measured after 4 weeks

• erythrocyte sedimentation rate (1 hour)

  It was measured after 4 weeks

• erythrocyte sedimentation rate (2 hour)

  It was measured after 4 weeks

Study Arms (2)

group 1

ACTIVE COMPARATOR

thirty lupus women received laser acupuncture (active) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser was applied for 1 min on every acupiont).

Device: laser application on acupoints

group 2

SHAM COMPARATOR

thirty lupus women received laser acupuncture (sham) for one month (3 days) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser was be applied for 1 min on every acupiont).

Device: laser application on acupoints

Interventions

laser application on acupoints DEVICE

laser acupuncture

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 47 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• lupus females
• patients

You may not qualify if:

• pregnancy
• cardiovascular diseases
• respiratory diseases

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 21, 2021
• Study Start: July 12, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 30, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

EG (1)