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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2025-06-07

Brief Summary

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

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Detailed Description

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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

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Low Back Pain Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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calcium supplementation

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

Group Type ACTIVE_COMPARATOR

calcium supplementation

Intervention Type DRUG

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.

calcium supplementation + manual therapy

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.

Group Type EXPERIMENTAL

calcium supplementation

Intervention Type DRUG

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 therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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665 mg calcium citrate

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No