Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: calcium supplementation, Manual therapy.
- Who it may be relevant to
- Registry conditions: Low Back Pain, Osteopenia. Basic parameters: 50 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug calcium supplementation
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. - Other Manual therapy
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.
Primary outcome measures
- Assessment of Low back pain severity [Time frame: 12 weeks]
- Measurement of lumbar curvature angle. [Time frame: 12 weeks]
- Assessment of Lumbar Flexion [Time frame: 12 weeks]
- Assessment of Lumbar Extension [Time frame: 12 weeks]
- Assessment of Lumbar Lateral bending to the right side [Time frame: 12 weeks]
- Assessment of Lumbar Lateral bending to the left side [Time frame: 12 weeks]
- Assessment of functional disability related to low back pain [Time frame: 12 weeks]
Secondary outcome measures (2)
- Measurement of lumbar Bone Mineral Density (BMD) [Time frame: 12 weeks]
- Assessment of quality of life [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Giza
Identifiers
NCT: NCT06671665 · P.T.REC/012/005212