Osteoporosis, PostmenopausalNCT05559619
Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women
A study testing Calcium carbonate, Vitamin D3 and laser acupuncture therapy in people with Osteoporosis, Postmenopausal, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Calcium carbonate, Vitamin D3 and laser acupuncture therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2021to 6 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- history of bone disease, renal, liver, endocrinal or parathyroid disorders, cardiac affection,
- using a pacemaker
- taking any drugs which may affect bone metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Calcium carbonate, Vitamin D3, laser acupuncture therapy
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium carbonateDrug
Also called Calcium D3F
1000 mg of natural calcium carbonate once daily for 12 weeks
Vitamin D3Drug
Also called Calcium D3F
1000 IU vitamin D3 once daily for 12 weeks
laser acupuncture therapyDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Calcium carbonate; Drug: Vitamin D3; Device: laser acupuncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
T-score of Forearm bone mineral density that was evaluated by dual energy X-ray absorptiometry
Measured: 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.
Measured: 12 weeks after theray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start11 Jul 2021
- Primary completion5 Jun 2022
- Study completion6 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed M Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559619
- Sponsor's protocol ID
- 65
- Status last verified
- Feb 2024
- First submitted
- 26 Sep 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36944142
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05559619
- Acronym / sponsor ID
- 65
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 6 Aug 2022 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug treatment group | Active comparator | Drug: Calcium carbonate, Drug: Vitamin D334 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 | Active comparator | Drug: Calcium carbonate, Drug: Vitamin D3, Device: laser acupuncture therapy34 postmenopausal women who received laser acupuncture therapy in addition to the same calcium and vitamin D3 supplement for 12 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- history of bone disease, renal, liver, endocrinal or parathyroid disorders, cardiac affection,
- using a pacemaker
- taking any drugs which may affect bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium carbonateAlso: Calcium D3F1000 mg of natural calcium carbonate once daily for 12 weeks | Drug | Drug treatment + laser acupuncture group, Drug treatment group |
| Vitamin D3Also: Calcium D3F1000 IU vitamin D3 once daily for 12 weeks | Drug | Drug treatment + laser acupuncture group, Drug treatment group |
| laser acupuncture therapyThe 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 | Device | Drug treatment + laser acupuncture group |
Primary outcome
Bone mineral density
Time frame: 12 weeks after theray
T-score of Forearm bone mineral density that was evaluated by dual energy X-ray absorptiometry
Pain Visual analogue score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 36944142Hassan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium carbonate, Vitamin D3 and laser acupuncture therapy in people with Osteoporosis, Postmenopausal, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 12 weeks after theray). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.