Low Back PainNCT06985849
Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain
A study testing Feldenkrais method and Otago exercise protocol. in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Feldenkrais method and Otago exercise protocol.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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)
Show all 10Show fewer
- 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
Who cannot join
- • Recurrent spinal surgery(3)
- Malignancy
- Spine Infection
- Spinal fracture
- Congenital disturbance
- Severe LBP (NPRS ≥ 9/10)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Farooq Hospital
Lahore, 54000
manahil zahra, msompt
About this study
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
- Being tested
- Feldenkrais method, Otago exercise protocol.
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais methodOther
"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
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Otago exercise protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start15 Dec 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985849
- Sponsor's protocol ID
- REC/RCR & AHS/24/0181
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33849907Senbursa 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.
PubMed 32438535Ahmadi 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.
PubMed 32723088
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Feldenkrais and Otago Exercise Protocols for Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06985849
- Acronym / sponsor ID
- REC/RCR & AHS/24/0181
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feldenkrais method. | Experimental | Other: Feldenkrais methodGroup 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 |
| Otago exercise protocol. | Active comparator | Other: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Age group 18 to 65 year (3)
Key exclusion criteria (10 listed)
- • Recurrent spinal surgery(3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feldenkrais method"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 | Other | Feldenkrais method. |
| 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.(12) | Other | Otago exercise protocol. |
Primary outcome
Berg Balance Scale ( BBS)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 33849907Gianola 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.
- Background: PubMed 32438535Senbursa 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.
- Background: PubMed 32723088Ahmadi 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabiya Noor, PHD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feldenkrais method and Otago exercise protocol. in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iqbal Tariq, PHD (03338236752, Iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale ( BBS) (time frame: baseline and fourth week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.