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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-60
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Osteoporosis.

Having osteoporotic fractures.

Having a lumbar surgery previously.

Neurological disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • calcium supplementation

    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

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: calcium supplementationActive comparator 1 intervention
Group B: calcium supplementation + manual therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks

Other outcomes

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