Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain

NCT06750380 | Completed

• 1 other identifier: REC/RCR&AHS/24/0527
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Group A will receive tailored mat exercises. Group B will receive Mckenzie exercises. A baseline treatment including moist hot pack and TENS will be given to both of these groups. All these sessions will be of 45 minutes for 2 session per week for 10 weeks.

Conditions

Back Pain, Low

Keywords

exercises; disability; postmenopausal; women; chronic; low back pain

Outcome Measures

Primary Outcomes (3)

• Visual analogue Scale

  Pain experienced in the last 24 h will be assessed with the pain VAS. The scale is an unnumbered 100 mm line, one end of which has the phrase "no pain" and the other "maximum pain". A mark is placed by the patient at a point representing their pain level. That mark is then measured by the tester with a millimeter ruler. Each measurement of the pain VAS corresponded to pain experienced in the last week, with lower values indicating less pain. The pain VAS is the most commonly used instrument for measuring low back pain intensity and its use is indicated in older adults It has high reliability with an intraclass correlation coefficient (ICC) of 0.99.

  10th week

• Roland-Morris disability questionnaire (RMDQ)

  Roland-Morris disability questionnaire (RMDQ) The Greek version of the RMDQ was used to assess disability associated with low back pain in the last 24 h. This questionnaire has shown high test-retest reliability in older adults, with an intraclass correlation coefficient (ICC) of 0.85. The RMDQ consists of 24 items related to the daily activities patients often report having difficulty performing due to low back pain. Every positive answer earns one point; the final score is the total sum. The higher the score, the greater is the limitation

  10th week

• Timed up-and-go (TUG) test

  The TUG is a performance-based measure of functional mobility initially developed to identify mobility and balance impairments in older adults. The TUG has demonstrated high interrater and intrarater reliability when used to examine older adults (ICC=0. 99). The patient is scored based on the time required to perform the following sequence of actions: stand up from a chair, walk at their own pace a distance of 3 m to a marked spot on the floor, turn around, return to the chair and sit back down

  10th week

Study Arms (2)

Tailored mat exercise program

EXPERIMENTAL

The Group A will receive TENS plus moist hot pack and follow the Tailored mat exercise program for 10 weeks, two times per week, in 45-min sessions under supervision of trained physical therapist. The choice of exercises will be made based on the suggested exercises of Wood for the treatment of back pain, while the easiest versions of each exercise would be selected in order for the program to be adapted to older adults. Patient's outcomes will be measured at baseline and after 10 weeks.

Other: Tailored mat exercise program

McKenzie exercises

ACTIVE COMPARATOR

The Group B will receive McKenzie exercises plus moist hot pack and TENS in the region of lumbar spine for 10 minutes and Mckenzie exercises of seven to ten repetitions for 45 min/session two times per week for ten weeks. Patient's outcomes will be measured at baseline and after 10 weeks

Other: McKenzie exercises

Interventions

Tailored mat exercise program OTHER

The Group A will receive TENS plus moist hot pack and follow the Tailored mat exercise program for 10 weeks, two times per week, in 45-min sessions under supervision of trained physical therapist. The choice of exercises will be made based on the suggested exercises of Wood for the treatment of back pain, while the easiest versions of each exercise would be selected in order for the program to be adapted to older adults. Patient's outcomes will be measured at baseline and after 10 weeks.

Tailored mat exercise program

McKenzie exercises OTHER

The Group B will receive McKenzie exercises plus moist hot pack and TENS in the region of lumbar spine for 10 minutes and Mckenzie exercises of seven to ten repetitions for 45 min/session two times per week for ten weeks. Patient's outcomes will be measured at baseline and after 10 weeks.

McKenzie exercises

Eligibility Criteria

• Age: 55 Years - 85 Years
• Gender Eligibility Details: post-menopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic nonspecific low back pain (more than 12 weeks)
• Moderate pain VAS\>30mm and\< 70mm
• TUG score of \< 15s
• Female who had entered menopause (menstrual periods have stopped for 12 months)
• Stable vital signs (patient is stable and vital signs are within normal limits)
• Multigravida

You may not qualify if:

• Frailer individuals
• Radiculopathy (signs of sensory loss, muscle weakness, reduced tendon reflexes)
• Women suffering from pathological conditions for example cardiac disease, cancer, vertebral fracture, osteomyelitis, Rheumatoid arthritis, cauda equina syndrome) participation in another lower back specific exercise program in the last 6 months
• Participation in a previous Pilates exercise program
• Neurodegenerative disease (e.g., Parkinson's disease)
• Recent stroke and cognitive impairment (Mini Mental State Exam score \< 24)
• History of recent fracture

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

CMH (Combined Military Hospital)

Lahore, Punjab Province, 6400, Pakistan

Location

Related Publications (6)

• Fonseca LS, Silva JP, Souza MB, Mascarenhas RO, Silva HJ, Campos MGM, Pereira LSM, Oliveira MX, Oliveira VC. Efficacy of pharmacological and non-pharmacological therapy on pain intensity and disability of older people with chronic nonspecific low back pain: a protocol for a network meta-analysis. Syst Rev. 2023 Nov 7;12(1):205. doi: 10.1186/s13643-023-02369-0.

  PMID: 37936147 BACKGROUND

• Bais A, Mishra SA, Darda PP, Phansopkar P. Impact of 6 weeks pilates training on menopause specific symptoms and quality of life in menopausal women: a case report. Journal of Pharmaceutical Research International. 2021 Jul 19;33(37B):83-9.

  BACKGROUND

• Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.

  PMID: 35507483 BACKGROUND

• Ravindran AK, Javed J, Parthiban R, Sherrif B. Effectiveness of aerobic exercise versus pilates in postmenopausal women with non-specific chronic low back pain. Indian Journal of Physiotherapy & Occupational Therapy Print-(ISSN 0973-5666) and Electronic-(ISSN 0973-5674). 2022 Apr 13;16(2):1-8.

  BACKGROUND

• Belli G, Esposito C, Campanella M, Vista E, Pegreffi F, Maietta Latessa P. Comparison of Core Stability versus McKenzie Exercises in people with low back pain: effects induced by 4 weeks of training on pain, flexibility and spine mobility. SPORT SCIENCES FOR HEALTH (ONLINE). 2022:45-.

  BACKGROUND

• Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.

  PMID: 33591367 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• hina gul, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)