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

NCT06985849 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0181
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale ( BBS)

  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.

  baseline and fourth week

• Oswestry Disability Index (ODI)

  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.

  baseline and fourth week

Study Arms (2)

Feldenkrais method.

EXPERIMENTAL

Group A will receive awareness through movement lessons, which are verbally, guided explorations of movement, conducted by a physiotherapist. The Feldenkrais method intervention consisted of 10 structured lessons, each 30 minutes in duration, delivered twice weekly. The program aimed to enhance trunk mobility and overall function without pain. Lessons progressed sequentially, building upon previous sessions. Segment 1 (Lesson 1-2) focused on breathing awareness and trunk perception in supine position, gaining control of the pelvis, and freeing hip joints. Segment 2 (Lesson 3-4) addressed flexion-extension and self-care in supine and prone positions. Segment 3 (Lesson 5-6) targeted flexion-extension, rotation, and shoulder control. Segment 4 (Lesson 7-8) emphasized balance and walking. The final lessons (9-10) integrated previous themes, reinforcing functional improvement

Other: Feldenkrais method

Otago exercise protocol.

ACTIVE COMPARATOR

The study began by completing all 3-outcome measures by first asking about their pain intensity then by checking their balance through Berg Balance Scale and then checking the level of function through ODI questionere. The OEP included the following exercises: knee extension and knee flexion, hip abduction, calf raises, toe raises, sit to stand, semi squats from a standing position, tandem stand, tandem walk, sideways walking, backwards walking, heel walking, toe walking, one leg stand, and walking and turning around. All exercises will be performed with 10-20 repetitions, which will be progressed after 2 week

Other: Otago exercise protocol.

Interventions

Feldenkrais method OTHER

"Activating flexors" "The pelvic clock"twisting)."Side lying lesson for improving the integration of arms, shoulders and spine" (reaching motion of shoulders in different directions)."Transitioning from supine to side lying to sitting" (lying supine involving flexion, extension, and twisting)."Twisting on the side" "Twisting from supine with head fixed to the side" (by limiting the movement of the head, the rib cage is forced to participate in the twisting motion) "Lengthening the hamstrings" "Arm circles" (lying on side, circling arms in different directions). "Rolling from supine to prone via hip rotation

Feldenkrais method.

Otago exercise protocol. OTHER

The study began by completing all 3-outcome measures by first asking about their pain intensity then by checking their balance through Berg Balance Scale and then checking the level of function through ODI questionere. The OEP included the following exercises: knee extension and knee flexion, hip abduction, calf raises, toe raises, sit to stand, semi squats from a standing position, tandem stand, tandem walk, sideways walking, backwards walking, heel walking, toe walking, one leg stand, and walking and turning around. All exercises will be performed with 10-20 repetitions, which will be progressed after 2 week.(12)

Otago exercise protocol.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Farooq Hospital

Lahore, 54000, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 33849907 BACKGROUND

• 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.

  PMID: 32438535 BACKGROUND

• 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.

  PMID: 32723088 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Rabiya Noor, PHD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iqbal Tariq, PHD

CONTACT

03338236752; Iqbal.tariq@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: December 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)