Clinical trial NCT06671665: Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
Official title: Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Osteopenia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Ambulatory, sedentary, non-smoking women having natural menopause at least 1 year before participation in the study.
2. Their ages will range from 50 to 60 years old.
3. Their BMI will be \> 30 kg/m2.
4. Pain before costal margin and above inferior gluteal fold.
5. Osteopenia.

Exclusion Criteria:

1. Osteoporosis.
2. Having osteoporotic fractures.
3. Having a lumbar surgery previously.
4. Neurological disorder.
5. Known diseases affecting bone quality (hyperthyroidism, hyperparathyroidism, hypercortisolism, etc).
6. Receiving any medical or hormonal therapies that could affect the bone metabolism.
7. Receiving previous manual treatment.

Primary outcomes:
measure: Assessment of Low back pain severity
timeFrame: 12 weeks
measure: Measurement of lumbar curvature angle.
timeFrame: 12 weeks
measure: Assessment of Lumbar Flexion
timeFrame: 12 weeks
measure: Assessment of Lumbar Extension
timeFrame: 12 weeks
measure: Assessment of Lumbar Lateral bending to the right side
timeFrame: 12 weeks
measure: Assessment of Lumbar Lateral bending to the left side
timeFrame: 12 weeks
measure: Assessment of functional disability related to low back pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Measurement of lumbar Bone Mineral Density (BMD)
timeFrame: 12 weeks
measure: Assessment of quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Cairo University
name: Amel M. Yousef, PhD
role: STUDY_CHAIR
References: