- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06985849
- Original Trial
Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: iqbal Tariq, phd
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
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Lahore, Pakistan, 54000
- Recruiting
- Farooq Hospital
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Contact:
- manahil zahra, msompt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feldenkrais method.
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
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"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
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Active Comparator: Otago exercise protocol.
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
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale ( BBS)
Time Frame: baseline and fourth week
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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.
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baseline and fourth week
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Oswestry Disability Index (ODI)
Time Frame: baseline and fourth week
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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.
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baseline and fourth week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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