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

NCT05559619 | Completed DMC

• 1 other identifier: 65
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

• Bone mineral density

  T-score of Forearm bone mineral density that was evaluated by dual energy X-ray absorptiometry

  12 weeks after theray

• Pain Visual analogue score

  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.

  12 weeks after theray

Study Arms (2)

Drug treatment group

ACTIVE COMPARATOR

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; Drug: Vitamin D3

Drug treatment + laser acupuncture group

ACTIVE COMPARATOR

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

Drug: Calcium carbonate; Drug: Vitamin D3; Device: laser acupuncture therapy

Interventions

Calcium carbonate DRUG

1000 mg of natural calcium carbonate once daily for 12 weeks

Also known as: Calcium D3F

Drug treatment + laser acupuncture group; Drug treatment group

Vitamin D3 DRUG

1000 IU vitamin D3 once daily for 12 weeks

Also known as: Calcium D3F

Drug treatment + laser acupuncture group; Drug treatment group

laser acupuncture therapy DEVICE

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

Drug treatment + laser acupuncture group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Related Publications (1)

• Hassan ES, Maged AM, Kotb A, Fouad M, El-Nassery N, Kamal WM. Effect of laser acupuncture on pain and density of bone in osteoporotic postmenopausal women: a randomized controlled trial. Menopause. 2023 May 1;30(5):545-550. doi: 10.1097/GME.0000000000002166. Epub 2023 Mar 20.

  PMID: 36944142 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Calcium Carbonate; Cholecalciferol

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ahmed M Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: July 11, 2021
• Primary Completion: June 5, 2022
• Study Completion: August 6, 2022
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

EG (1)