Low Back PainNCT06671665
Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
A study testing calcium supplementation and Manual therapy in people with Low Back Pain and Osteopenia, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Low Back Pain, Osteopenia
- What is being tested?
- calcium supplementation and Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2024to 7 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Ambulatory, sedentary, non-smoking women having natural menopause at least 1 year before participation in the study.
- Their ages will range from 50 to 60 years old.
- Their BMI will be > 30 kg/m2.
- Pain before costal margin and above inferior gluteal fold.
- Osteopenia.
Who cannot join
- Osteoporosis.
- Having osteoporotic fractures.
- Having a lumbar surgery previously.
- Neurological disorder.
- Known diseases affecting bone quality (hyperthyroidism, hyperparathyroidism, hypercortisolism, etc).
- Receiving any medical or hormonal therapies that could affect the bone metabolism.
- Receiving previous manual treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
Hanan Karamallah Mohamed Abdelkawy, MSc, 01125665868, Hanan.Karamallah.Mohamed@gmail.com
Amel M. Yousef, PhD, 01222726511, Amelyousef@pt.cu.edu.eg
About this study
The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.
Read the detailed description
Women spend nearly one-third of their life in menopause. In this period, besides other comorbid conditions, women suffer from various musculoskeletal disorders also. One such problem is chronic low back pain which is more prevalent in post-menopausal women. This condition affects daily living activities of a person ranging from standing up, walking, bending over, lifting, traveling, social interaction, dressing to sleeping, living with ongoing pain causes depression, anxiety, deterioration in quality of life for women themselves. Despite this, little attention has been paid to pain in the spine/low back ache which are equally prevalent in this period of life.
Although this poses a great medical and socioeconomic challenge to such extent that some researchers call it a lifestyle disease. It is the main cause of absence in the workplace and the 2nd cause of visiting primary health-care professionals. Spine pain has negative psychological consequences as it impairs daily functioning. Therefore, finding an effective method for treatment is important.
Manual treatments are one of the most applied methods within physiotherapy approaches in recent years. Manual treatment (in the form of craniosacral and visceral manipulation) claiming to release the tension of the muscles, ligaments, and fascia in the sacral area and activate central pain inhibitory centers. For this reason, we are conducting the present study with a new view to identify the effects of manual therapy practices in the form of craniosacral and visceral manipulation on pain, function, and BMD of the lumbar region, as well as quality of life in osteopenic post-menopausal women suffering from low back pain.
- Conditions
- Low Back Pain, Osteopenia
- Being tested
- calcium supplementation, Manual therapy
- Medical subject headings
- Low Back Pain, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium supplementationDrug
Also called 665 mg calcium citrate
Patients in both groups received calcium supplementation in the form of tablets that contain 665 mg calcium citrate. Citrate is easily assimilated and metabolized which provides the maximum benefit of the formula. Dosage: one tablet daily.
Manual therapyOther
Manual therapy treatment will be in the form of craniosacral techniques and visceral manipulation techniques for 8 sessions in 12 weeks. Sessions will be divided into one session per week for the first 4 weeks then one session every two week for the next 8 weeks. Each session lasts for 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| calcium supplementation | Active comparator | It will consist of 20 postmenopausal women. They will receive calcium supplementation daily for 12 weeks. Receives: Drug: calcium supplementation |
| calcium supplementation + manual therapy | Experimental | It will consist of 20 postmenopausal women. They will receive the same calcium supplementation daily in addition to manual therapy (in form of craniosacral technique \& general visceral mobilization) for 12 weeks. Receives: Drug: calcium supplementation; Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Low back pain severity
Pain will be assessed by Visual analog scale (VAS). It is a scale that allows continuous data analysis and uses a 10cm line with 0 (0 = no pain) written at one end and 10 (10 = worst pain) on the other end. Subjects will be asked to place a mark along the line to denote their level of pain.
Measured: 12 weeks
Measurement of lumbar curvature angle.
It will be measured, before and after treatment program, using a flexible ruler. The flexible ruler will be molded to the midline contour of the lumber spine from the spinous process of T12 to S2 to measure the degree of lordosis which carefully traced onto paper using pencil. Then, the lumbar curvature angle will be measured by the equation (theta angle = 4Arctang 2H/L). In this equation, the theta angle represents the magnitude of the lordotic curve, L is a straight line from the first vertebrae to the last vertebrae and the H letter is the distance between the deep point of L line and the lumbar curve.
Measured: 12 weeks
Assessment of Lumbar Flexion
The examiner will stand behind the standing patient to identify the posterior superior iliac spines with thumbs, and then an ink mark will be drawn along the midline of the lumbar spine horizontal to the posterior superior iliac spines. Another ink mark will be made 15 cm above the original mark. The tape measure will be lined up between skin markings. With the tape pressed firmly against the subject's skin and while holding it with fingertips, the distance between superior and inferior skin marks will be measured. Then, the examiner will instruct the patient to bend forward into full lumbar flexion and the new distance between superior and inferior skin marks will be measured. The change in the difference between marks will be used to indicate the amount of lumbar flexion.
Measured: 12 weeks
Assessment of Lumbar Extension
The examiner will follow the same procedure done previously in lumbar flexion except with the instruction. As the examiner will instruct the patient to bend backward into full extension and the new distance between superior and inferior skin marks will be measured as a straight line. The change in the difference between marks will be used to indicate the amount of lumbar extension.
Measured: 12 weeks
Assessment of Lumbar Lateral bending to the right side
Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.
Measured: 12 weeks
Assessment of Lumbar Lateral bending to the left side
Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.
Measured: 12 weeks
Assessment of functional disability related to low back pain
Functional disability of each patient will be measured using Oswestry disability questionnaire. It is a valid and reliable tool consists of 10 multiple choice questions for back pain; subjects selected one sentence out of six that best describe her pain, higher scores indicated great pain. Scores of minimal disability:(0-20%), Scores of moderate disability: (20%- 40%), Scores of severe disability: (40% - 60%), Scores of crippled subjects: (60% - 80%), and Scores of patients confined to bed (80%-100%).
Measured: 12 weeks
Secondary outcomes (2)
Measurement of lumbar Bone Mineral Density (BMD)
The lumbar BMD of each postmenopausal woman in both groups will be measured before entry into the study to confirm her diagnosis of osteopenia (from -1.1 to -2.49 SD) and also after 12 weeks of treatment, using DEXA, which represents the most preferable method for BMD calculation.
Measured: 12 weeks
Assessment of quality of life
It will be assessed through Short Form 36 Health Survey Questionnaire (SF-36) for both groups before and after the treatment. It comprises eight domain scores including 'physical functioning'. This domain asks respondents to report limitations on ten mobility activities, such as walking specified distances, carrying groceries and bathing or dressing. It is an established and widely used health-related quality of life measure.It consists of ten multiple choice questions for back pain; patient will select one sentence out of six that best describe her pain, higher scores will indicate greater pain and disability. It will be used to measure the level of functional disability due to low back pain. The scores were scaled to a range where 0 denotes the lowest health status and 100 denotes the highest.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start7 Nov 2024
- Primary completion7 May 2025 (estimated)
- Study completion7 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Karamallah Mohamed Abdelkawy, Cairo University
- Investigators
- Amel M. Yousef, PhD, Study chair, Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671665
- Sponsor's protocol ID
- P.T.REC/012/005212
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06671665
- Acronym / sponsor ID
- P.T.REC/012/005212
- Conditions
- Low Back Pain, Osteopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (estimated)
- Study completion
- 7 Jun 2025 (estimated)
- First posted
- 4 Nov 2024 (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.
The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.
Detailed description
Women spend nearly one-third of their life in menopause. In this period, besides other comorbid conditions, women suffer from various musculoskeletal disorders also. One such problem is chronic low back pain which is more prevalent in post-menopausal women. This condition affects daily living activities of a person ranging from standing up, walking, bending over, lifting, traveling, social interaction, dressing to sleeping, living with ongoing pain causes depression, anxiety, deterioration in quality of life for women themselves. Despite this, little attention has been paid to pain in the spine/low back ache which are equally prevalent in this period of life.
Although this poses a great medical and socioeconomic challenge to such extent that some researchers call it a lifestyle disease. It is the main cause of absence in the workplace and the 2nd cause of visiting primary health-care professionals. Spine pain has negative psychological consequences as it impairs daily functioning. Therefore, finding an effective method for treatment is important.
Manual treatments are one of the most applied methods within physiotherapy approaches in recent years. Manual treatment (in the form of craniosacral and visceral manipulation) claiming to release the tension of the muscles, ligaments, and fascia in the sacral area and activate central pain inhibitory centers. For this reason, we are conducting the present study with a new view to identify the effects of manual therapy practices in the form of craniosacral and visceral manipulation on pain, function, and BMD of the lumbar region, as well as quality of life in osteopenic post-menopausal women suffering from low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium supplementation | Active comparator | Drug: calcium supplementationIt will consist of 20 postmenopausal women. They will receive calcium supplementation daily for 12 weeks. |
| calcium supplementation + manual therapy | Experimental | Drug: calcium supplementation, Other: Manual therapyIt will consist of 20 postmenopausal women. They will receive the same calcium supplementation daily in addition to manual therapy (in form of craniosacral technique \& general visceral mobilization) 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)
- Ambulatory, sedentary, non-smoking women having natural menopause at least 1 year before participation in the study.
- Their ages will range from 50 to 60 years old.
- Their BMI will be > 30 kg/m2.
- Pain before costal margin and above inferior gluteal fold.
- Osteopenia.
Key exclusion criteria (7 listed)
- Osteoporosis.
- Having osteoporotic fractures.
- Having a lumbar surgery previously.
- Neurological disorder.
- Known diseases affecting bone quality (hyperthyroidism, hyperparathyroidism, hypercortisolism, etc).
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 supplementationAlso: 665 mg calcium citratePatients in both groups received calcium supplementation in the form of tablets that contain 665 mg calcium citrate. Citrate is easily assimilated and metabolized which provides the maximum benefit of the formula. Dosage: one tablet daily. | Drug | calcium supplementation, calcium supplementation + manual therapy |
| Manual therapyManual therapy treatment will be in the form of craniosacral techniques and visceral manipulation techniques for 8 sessions in 12 weeks. Sessions will be divided into one session per week for the first 4 weeks then one session every two week for the next 8 weeks. Each session lasts for 45 minutes. | Other | calcium supplementation + manual therapy |
Primary outcome
Assessment of Low back pain severity
Time frame: 12 weeks
Pain will be assessed by Visual analog scale (VAS). It is a scale that allows continuous data analysis and uses a 10cm line with 0 (0 = no pain) written at one end and 10 (10 = worst pain) on the other end. Subjects will be asked to place a mark along the line to denote their level of pain.
Measurement of lumbar curvature angle.
Time frame: 12 weeks
It will be measured, before and after treatment program, using a flexible ruler. The flexible ruler will be molded to the midline contour of the lumber spine from the spinous process of T12 to S2 to measure the degree of lordosis which carefully traced onto paper using pencil. Then, the lumbar curvature angle will be measured by the equation (theta angle = 4Arctang 2H/L). In this equation, the theta angle represents the magnitude of the lordotic curve, L is a straight line from the first vertebrae to the last vertebrae and the H letter is the distance between the deep point of L line and the lumbar curve.
Assessment of Lumbar Flexion
Time frame: 12 weeks
The examiner will stand behind the standing patient to identify the posterior superior iliac spines with thumbs, and then an ink mark will be drawn along the midline of the lumbar spine horizontal to the posterior superior iliac spines. Another ink mark will be made 15 cm above the original mark. The tape measure will be lined up between skin markings. With the tape pressed firmly against the subject's skin and while holding it with fingertips, the distance between superior and inferior skin marks will be measured. Then, the examiner will instruct the patient to bend forward into full lumbar flexion and the new distance between superior and inferior skin marks will be measured. The change in the difference between marks will be used to indicate the amount of lumbar flexion.
Assessment of Lumbar Extension
Time frame: 12 weeks
The examiner will follow the same procedure done previously in lumbar flexion except with the instruction. As the examiner will instruct the patient to bend backward into full extension and the new distance between superior and inferior skin marks will be measured as a straight line. The change in the difference between marks will be used to indicate the amount of lumbar extension.
Assessment of Lumbar Lateral bending to the right side
Time frame: 12 weeks
Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.
Assessment of Lumbar Lateral bending to the left side
Time frame: 12 weeks
Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.
Assessment of functional disability related to low back pain
Time frame: 12 weeks
Functional disability of each patient will be measured using Oswestry disability questionnaire. It is a valid and reliable tool consists of 10 multiple choice questions for back pain; subjects selected one sentence out of six that best describe her pain, higher scores indicated great pain. Scores of minimal disability:(0-20%), Scores of moderate disability: (20%- 40%), Scores of severe disability: (40% - 60%), Scores of crippled subjects: (60% - 80%), and Scores of patients confined to bed (80%-100%).
2 secondary outcomes
Measurement of lumbar Bone Mineral Density (BMD)
Time frame: 12 weeks
Assessment of quality of life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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.
Amel M. Yousef, PhD study chair
Professor, 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 supplementation and Manual therapy in people with Low Back Pain and Osteopenia, 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 7 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: looking for participants now, as of the sponsor's last update on 12 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanan Karamallah Mohamed Abdelkawy, MSc (01125665868, Hanan.Karamallah.Mohamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Low back pain severity (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.