Clinical trial NCT05559619: Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women
Official title: Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 68
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty-eight postmenopausal women diagnosed with osteoporosis aged between 50 and 60 years were randomly allocated to one of two equal sets. The drug treatment group received calcium and vitamin D3 supplement daily for 12 weeks. While the drug/laser acupuncture group received laser acupuncture therapy for 20 minutes per session 3 times weekly, in addition to the same calcium and vitamin D3 supplement.

Detailed description: Sixty-eight postmenopausal women diagnosed with osteoporosis were recruited from the outpatient clinic of obstetrics and gynaecology department, faculty of physical therapy, Cairo University. Women were enrolled and assessed for their eligibility to participate in the study. Inclusion criteria were: age between 50 and 60 years and the body mass index (BMI) between 25 and 35 Kg/m2. Multiparas with parity of 5 or more were included. They had decreased forearm BMD with T score of DEXA less than or equal to -2.5 and wrist pain with visual analogue scale (VAS) ≥ 3. They all have natural menopause for at least four years. They all were medically stable. Participants were excluded if they had history of bone disease, renal, liver, endocrinal or parathyroid disorders, cardiac affection, using a pacemaker or taking any drugs which may affect bone metabolism.

Each participant was informed about the study's nature, objective and usefulness, as well as her right to decline or leave the study at any time, and the confidentiality of any information gathered. A computer-based randomization program was used to randomize participants into two equal groups (Drug treatment Group and Drug treatment + LA Group). Drug treatment group (group A) included 34 postmenopausal women who only received oral calcium and vitamin D3 supplement (Calcium D3F® (Arab Company for Pharmaceutical\& medicinal plants (MEPACO-MEDIFOOD, EGPYT). Each tablet contains 1000 mg of natural calcium carbonate, 1000 IU vitamin D3 (0.025 mg) and 0.25 mg Sodium Fluoride. They received 1 tablet once daily for 12 weeks. Drug treatment + laser acupuncture group (group B) included of 34 postmenopausal women who received laser acupuncture therapy in addition to the same calcium and vitamin D3 supplement for 12 weeks.

Each woman in group (B) received 3 sessions per week of laser acupuncture, for 12 weeks. The patient was in crock lying for stimulation of acupoints in abdomen and lower limbs then asked to be in side lying for stimulation of acupoints in the back. After disinfection of the skin and careful localization of the acupoints, low level laser therapy (LLLT) (model: Lis 1050, SN: EM 13481014, manufactured by EME srl, Italy) was applied bilaterally on Dazhu (BL 11), Ganshu(BL 18), Pishu (BL20), Shenshu (BL23), Zusanli (ST 36), Sanyinjiao (Sp6), Jingmen(GB25), Yanglingquan (GB34) andXuanzhong (GB39) acupoints, while it was applied in the midline on Guanyuan (CV4) andMingmen (GV4) acupoints. Each acupoint was irradiated for 60 sec, with total duration of 20 min, wave length of 905 nm, average radiant power output of 12 mW, energy density of 2 J/cm2, pulse radiation of 200 ms and pulse frequency of 5000 Hz

Eligibility criteria: Inclusion Criteria

* age between 50 and 60 years
* body mass index (BMI) between 25 and 35 Kg/m2.
* Multiparas with a parity of 5 or more were included.
* They had decreased forearm BMD with T score of DEXA less than or equal to -2.5 wrist pain with visual analogue scale (VAS) ≥ 3
* natural menopause for at least four years

Exclusion Criteria:

* history of bone disease, renal, liver, endocrinal or parathyroid disorders, cardiac affection,
* using a pacemaker
* taking any drugs which may affect bone metabolism

Primary outcomes:
measure: Bone mineral density
timeFrame: 12 weeks after theray
measure: Pain Visual analogue score
timeFrame: 12 weeks after theray
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed M Maged
role: PRINCIPAL_INVESTIGATOR
References: