Clinical trial NCT06985849: Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain
Official title: Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Scale ( BBS)
timeFrame: baseline and fourth week
measure: Oswestry Disability Index (ODI)
timeFrame: baseline and fourth week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Farooq Hospital
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gianola S, Bargeri S, Del Castillo G, Corbetta D, Turolla A, Andreano A, Moja L, Castellini G. Effectiveness of treatments for acute and subacute mechanical non-specific low back pain: a systematic review with network meta-analysis. Br J Sports Med. 2022 Jan;56(1):41-50. doi: 10.1136/bjsports-2020-103596. Epub 2021 Apr 13.
citation: Senbursa G, Pekyavas NO, Baltaci G. Comparison of Physiotherapy Approaches in Low Back Pain: A Randomized Controlled Trial. Korean J Fam Med. 2021 Mar;42(2):96-106. doi: 10.4082/kjfm.20.0025. Epub 2020 May 22.
citation: Ahmadi H, Adib H, Selk-Ghaffari M, Shafizad M, Moradi S, Madani Z, Partovi G, Mahmoodi A. Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial. Clin Rehabil. 2020 Dec;34(12):1449-1457. doi: 10.1177/0269215520947069. Epub 2020 Jul 29.