Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women: A Randomized Controlled Trial

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05559619

Collaborator

(none)

Enrollment

Location

Arms

12.8

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal	Drug: Calcium carbonate Drug: Vitamin D3 Device: laser acupuncture therapy	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women

Actual Study Start Date :

Jul 11, 2021

Actual Primary Completion Date :

Jun 5, 2022

Actual Study Completion Date :

Aug 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug treatment group 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: Calcium carbonate 1000 mg of natural calcium carbonate once daily for 12 weeks Other Names: Calcium D3F Drug: Vitamin D3 1000 IU vitamin D3 once daily for 12 weeks Other Names: Calcium D3F
Active Comparator: Drug treatment + laser acupuncture group 34 postmenopausal women who received laser acupuncture therapy in addition to the same calcium and vitamin D3 supplement for 12 weeks.	Drug: Calcium carbonate 1000 mg of natural calcium carbonate once daily for 12 weeks Other Names: Calcium D3F Drug: Vitamin D3 1000 IU vitamin D3 once daily for 12 weeks Other Names: Calcium D3F Device: laser acupuncture therapy 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

Arm

Intervention/Treatment

Active Comparator: Drug treatment group

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: Calcium carbonate

1000 mg of natural calcium carbonate once daily for 12 weeks

Other Names:

Calcium D3F

Drug: Vitamin D3

1000 IU vitamin D3 once daily for 12 weeks

Other Names:

Calcium D3F

Active Comparator: Drug treatment + laser acupuncture group

34 postmenopausal women who received laser acupuncture therapy in addition to the same calcium and vitamin D3 supplement for 12 weeks.

Drug: Calcium carbonate

1000 mg of natural calcium carbonate once daily for 12 weeks

Other Names:

Calcium D3F

Drug: Vitamin D3

1000 IU vitamin D3 once daily for 12 weeks

Other Names:

Calcium D3F

Device: laser acupuncture therapy

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

Outcome Measures

Primary Outcome Measures

Bone mineral density [12 weeks after theray]
T-score of Forearm bone mineral density that was evaluated by dual energy X-ray absorptiometry
Pain VAS score [12 weeks after theray]
It is a 10-cm horizontal line on which a mark between the extremes of "no pain at all" and "worst agony conceivable" was used to reflect the patient's level of discomfort.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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