Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain

Not Applicable

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06985849
• Lead Sponsor: Riphah International University

Brief Summary

Low back pain (LBP) is a common health issue-affecting individual across diverse ages and socio- economic backgrounds, with approximately 80% of the population experiencing this musculoskeletal concern at some point in their lives. Despite its prevalence, the prognosis for LBP is generally favorable, emphasizing the importance of effective management strategies aimed at reducing pain and improving functional ability. The Feldenkrais Method and the Otago Exercise Programme (OEP) are two interdisciplinary approaches that have demonstrated promise in addressing mechanical non-specific low back pain. This study aims to evaluate the effectiveness of these two intervention protocols in alleviating chronic low back pain while concurrently enhancing functional abilities and reducing the risk of falls among older adults.

The study will be a randomized controlled trial conducted on participants. Data will be collected from Farooq hospital and Boston physiotherapy and wellness clinic. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and participant's age between 45-65, having mechanical low back pain for more than 3 months will be recruited in study after computer generated randomization. However, participants who have any chronic illness like recurrent spinal surgery, Malignancy, Spine Infection, Spinal fracture and congenital disturbance shall be excluded from this study. The subjects will be divided into two groups. Group A will receive awareness through movement sessions of trunk mobility, which will be guided verbally(such as rolling head left and right, bringing knees to chest, tilting to the sides, rolling pelvis.) and Group B will receive lower limb strength and balance exercises like knee extensions and hip abduction.

All these sessions will be of 30 minutes to for 2 sessions per week for 6 weeks. Pre and post assessments will be conducted and the tools that will be used are NPRS for pain, Universal goniometer for ROM, Functional disability (Oswestry Disability Index), Falls-related self-efficacy will be assessed by the Activities-Specific Balance Confidence (ABC) Scale. and Balance (Berg Balance Scale). Data will be analyzed by using SPSS version 26.0.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-15
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• • Age group 18 to 65 year (3)

  • Both gender male and female
  • LBP (duration ≥ 3 months) (3)
  • NPRS score ≥ 4/10 (indicating moderate pain)
  • ODI: Score ≥ 20/100 (indicating moderate disability)
  • BBS: Score ≤ 45/56 (indicating balance impairment)
  • BC Scale score: ≤ 60/100 (indicating moderate to low balance confidence)
  • Ability to walk independently
  • No severe cognitive impairment
  • Patient willing to perform in the study

Exclusion Criteria

• • Recurrent spinal surgery(3)

  • Malignancy
  • Spine Infection
  • Spinal fracture
  • Congenital disturbance
  • Severe LBP (NPRS ≥ 9/10)
  • Significant balance impairment (BBS ≤ 20/56)
  • Severe disability (ODI ≥ 60/100)
  • ABC Scale score: ≥ 80/100 (indicating high balance confidence)
  • Older individuals with specific health conditions, such as cardiovascular disease and diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale ( BBS)	baseline and fourth week	It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. Berg Balance Scale Sensitivity is 0.75-0.91 and Specificity is 0.67-0.85 (ability to identify those without balance impairment)It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Oswestry Disability Index (ODI)	baseline and fourth week	It is a patient-completed questionnaire that gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. It was developed by Jeremy Fairbank and Graham Pynsent in Oswestry, England in 1980 and considered one of the best-accepted tools for assessment of low back pain. ODI Sensitivity (0.74-0.92) and Specificity is (0.63-0.85), The questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consist of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.

Trial Locations

Locations (1)

Farooq Hospital; 🇵🇰 Lahore, Pakistan