Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women

Cairo University (CU)

Status: Enrolling

Conditions: Osteopenia; Low Back Pain

Treatments: Drug: calcium supplementation; Other: Manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06671665

P.T.REC/012/005212

Details and patient eligibility

About

The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

calcium supplementation

Active Comparator group

Description:

It will consist of 20 postmenopausal women. They will receive calcium supplementation daily for 12 weeks.

Treatment:

Drug: calcium supplementation

calcium supplementation + manual therapy

Experimental group

Description:

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.

Treatment:

Other: Manual therapy

Drug: calcium supplementation