Effect of Mulligan Technique Versus Core Stability Exercises on Low Back Pain in Post Menopausal Women

NCT06634550 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005170
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare the effect of Mulligan technique and core stability exercises on low back pain in post menopausal women.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Pain intensity level

  The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain

  4 weeks

• Lumbar flexion range of motion

  The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).

  4 weeks

• Lumbar extension range of motion

  The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1cm should be considered abnormal).

  4 weeks

• Assessment of lateral flexion range of motion

  The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.

  4 weeks

Secondary Outcomes (1)

• Functional disability

  4 weeks

Study Arms (3)

Mulligan technique group

EXPERIMENTAL

The participants will receive Mulligan technique and lifestyle modification advice for 4 weeks

Other: Mulligan technique; Other: Lifestyle modification advice

Core stability exercise group

EXPERIMENTAL

The participants will receive core stability exercises and lifestyle modification advice for 4 weeks

Other: Core stability exercise; Other: Lifestyle modification advice

Lifestyle modification advice group

ACTIVE COMPARATOR

The participants will receive lifestyle modification advice only for 4 weeks

Other: Lifestyle modification advice

Interventions

Mulligan technique OTHER

The participants will receive Mulligan technique (modified SNAGs) (10 rep. / 3 sets with 5 min rest in between) for 30 minutes, 3 sessions / week in addition to lifestyle modification advice for 4 weeks.

Mulligan technique group

Core stability exercise OTHER

The participants will perform core stability exercises (spinus multifiduse ex, diaphragmatic strengthening ex, frontal plank, pelvic floor ex,) 3 sessions / week for 30 min each session in addition to lifestyle modification advice for 4 weeks

Core stability exercise group

Lifestyle modification advice OTHER

The participants will receive lifestyle modification advice only for 4 weeks

Core stability exercise group; Lifestyle modification advice group; Mulligan technique group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sixty postmenopausal women (at least one year after stoppage of menses).
• Their age will be ranged from 50 to 60 years.
• All of them are diagnosed with chronic low back pain.
• Their BMI will be less than 30 kg/ m2.
• All of them are of sedentary lifestyle.
• The score of pain will be 2 or more in a VAS.

You may not qualify if:

• Participants will be excluded from the study if they have:
• Spinal fractures or any other neurological disorders.
• Lumber disc herniation or spondylolithesis
• Body mass index more than 30 kg/m2.
• Pelvic pathology
• Gynecological diseases as chronic pelvic pain, uterine prolapse or retroversion flexion of the uterus.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hala Ali Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Azza B Kassab, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Hala A. Mohamed, Master

CONTACT

+200103611530; halaali23995@gmail.com

Mohamed F Abo Eleinien, professor

CONTACT

+201001414404; drmohamedfawzy61@icloud.com

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: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 30, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)