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

NCT06671665 | Recruiting

• 1 other identifier: P.T.REC/012/005212
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain; Osteopenia

Outcome Measures

Primary Outcomes (7)

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• Assessment of Lumbar Lateral bending to the right side

  Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.

  12 weeks

• Assessment of Lumbar Lateral bending to the left side

  Measuring the distance between the tip of the middle finger and the floor when the patient stands upright, heels, buttocks and shoulders against the wall, and bends sideways without lifting the opposite foot off the ground.

  12 weeks

• Assessment of functional disability related to low back pain

  Functional disability of each patient will be measured using Oswestry disability questionnaire. It is a valid and reliable tool consists of 10 multiple choice questions for back pain; subjects selected one sentence out of six that best describe her pain, higher scores indicated great pain. Scores of minimal disability:(0-20%), Scores of moderate disability: (20%- 40%), Scores of severe disability: (40% - 60%), Scores of crippled subjects: (60% - 80%), and Scores of patients confined to bed (80%-100%).

  12 weeks

Secondary Outcomes (2)

• Measurement of lumbar Bone Mineral Density (BMD)

  12 weeks

• Assessment of quality of life

  12 weeks

Study Arms (2)

calcium supplementation

ACTIVE COMPARATOR

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

Drug: calcium supplementation

calcium supplementation + manual therapy

EXPERIMENTAL

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.

Drug: calcium supplementation; Other: Manual therapy

Interventions

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.

Also known as: 665 mg calcium citrate

calcium supplementation; calcium supplementation + manual therapy

Manual therapy 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.

calcium supplementation + manual therapy

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Bone Diseases, Metabolic

Interventions

Calcium Citrate; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Amel M. Yousef, PhD

  Professor, Cairo University

  STUDY CHAIR

Central Study Contacts

Hanan Karamallah Mohamed Abdelkawy, MSc

CONTACT

01125665868; Hanan.Karamallah.Mohamed@gmail.com

Doaa A. Osman, PhD

CONTACT

01115792245; Doaa.osman@cu.ed.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 7, 2024
• Primary Completion: May 7, 2025
• Study Completion: June 7, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

EG (1)