Low Back PainNCT07068334
Effects of FAKTR Therapy on Muscle Activity, Ankle Proprioception and Foot Biomechanics in OP With Low Back Pain
A study testing Traditional Physical Therapy and Traditional Physical Therapy + FAKTR in people with Low Back Pain, run by Superior University at 1 site in Pakistan.
Trial summary
Low back pain is sometimes non-specific, leading to pain and spasm due to muscle imbalance causing changes in biomechanical properties, back and limb muscles, leading to dictating a significant association between low back pain and overpronation. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Traditional Physical Therapy and Traditional Physical Therapy + FAKTR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Jun 2026
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-45
- Both males and females
- History of three or more occurrences of lower back pain in the year before the study. - The diagnosis is confirmed by the pain experienced between the inferior gluteal folds and the costal margins.
- Moderate to severe pain is measured using a Numerical pain rating scale.
- Foot Posture Index score higher than +6. A total score ranging from -12 to +12 is obtained by measuring the subject's six feet using the Foot Posture Index (FPI). The following are the reference values for the posture of the feet: A neutral position is indicated by 0 to +5, a pronated position by +6 to +9, a hyper-pronated position by +10 to +12, a supinated position by -1 to -5, and a very supinated position by -6 to - 12.
Who cannot join
- No recent history of lower limb fractures or injuries
- No history of surgical treatment experience for spinal stenosis, spina bifida, or disc herniation
- No neurological issues or constriction of the nerve roots.
- Previously diagnosed with Osteoporosis.
- SIJ dysfunction evaluated by Compression test positive
- Congenital deformities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arif memorial teaching hospital, ferozepur road
Lahore, Punjab Province
About this study
Official title: Effects of Functional and Kinetic Treatment With Rehabilitation (FAKTR) Therapy on Muscle Activity, Ankle Proprioception and Foot Biomechanics in Over Pronated Patients With Chronic Non-specific Low Back Pain
Low back pain is sometimes non-specific, leading to pain and spasm due to muscle imbalance causing changes in biomechanical properties, back and limb muscles, leading to dictating a significant association between low back pain and overpronation. FAKTR (functional and kinetic treatment with rehabilitation) Therapy employs this mobilization with proprioception and resistance treating these biomechanical changes.
Read the detailed description
This study aims to determine the effects of FAKTR (functional and kinetic treatment with rehabilitation) therapy on muscle activity, ankle proprioception and foot biomechanics on over-pronated foot in patients with chronic non-specific low back pain. This study will be a Randomized Controlled trial and will be conducted on sample size of 60 patients, will be taken by consecutive sampling techniques. Patients will be randomly assigned into two groups.
- Conditions
- Low Back Pain
- Being tested
- Traditional Physical Therapy, Traditional Physical Therapy + FAKTR
- 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.
Traditional Physical TherapyCombination product
Short foot exercises. Towel-curl exercise. Heel raise exercise. Calf stretch.
Traditional Physical Therapy + FAKTRCombination product
Short foot exercises. Towel-curl exercise. Heel raise exercise. Calf stretch.
FAKTR Functional and Kinematic Treatment with Rehabilitation) technique:
The FAKTR (Functional and Kinematic Treatment with Rehabilitation) technique applied is a modified IASTM technique in the pain-provocative position (incorporating static positions, motions, functional movements, resistance, and proprioceptive positions).
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy: | Experimental | Not described Receives: Combination Product: Traditional Physical Therapy |
| Traditional Physical Therapy + FAKTR | Active comparator | Not described Receives: Combination Product: Traditional Physical Therapy + FAKTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
This scale will be used to determine the participant's pain threshold. This scale has a 0 to 10 range. The pain scale goes from zero (no pain) to ten (highest agony). High test-retest reliability has been demonstrated using NPRS (r = 0.96 and 0.95, respectively)
Measured: 18 Months
Balance of the Error Scoring System (BESS)
The BESS incorporates three stances-double, single, and tandem-to assess static balancing skills. It takes 20 seconds to accomplish each stance. In the BESS, a participant's score is determined by how many mistakes they make; each mistake is worth one point. Opening the eyes, stepping, stumbling, falling, staying out of position for more than five seconds, shifting the hip into more than 30 degrees of flexion or abduction, elevating the forefoot or heel, and lifting the hands of the iliac crests are all examples of potential mistakes. Each posture is permitted to have a maximum of 10 points. A contestant will receive a maximum score of 10 for that stance if they are unable to hold it for five seconds. The total score of the BESS ranges from 0 to 60 and is calculated as the sum of the error points given for each of the six stances.
Measured: 18 Months
Oswestry Disability Index (ODI)
The Oswestry Handicap Index, also known as the Oswestry Low Back Pain Disability Questionnaire, is a very crucial instrument to assess a patient's functional disability over the long term. The evaluation is regarded as the "gold standard" for measuring low-back functional results. The final score/index is on a scale of 0 to 100. Scores range from 0 to 20 for mild impairment, 21 to 60 for severe disability, 61 to 80 for crippled, and 81 to 100 for bed bound.
Measured: 18 Months
Valgus angle by goniometer
The hindfoot valgus angle, also known as the valgus angle behind the ankle, is calculated by drawing a line between the midline of the heel and the midline of the lower part of the leg when the participant is in prone lying. After the procedure, the participant will be instructed to stand up, and the angle will be measured once more using a goniometer. Overpronation is defined as a value greater than nine, with 180 degrees being the usual angle. The reliability for angle dorsiflexion is 0.12-0.73 ICC, and the validity is 0.51-0.83
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068334
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2222
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional and Kinetic Treatment With Rehabilitation (FAKTR) Therapy on Muscle Activity, Ankle Proprioception and Foot Biomechanics in Over Pronated Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07068334
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2222
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jul 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 is sometimes non-specific, leading to pain and spasm due to muscle imbalance causing changes in biomechanical properties, back and limb muscles, leading to dictating a significant association between low back pain and overpronation. FAKTR (functional and kinetic treatment with rehabilitation) Therapy employs this mobilization with proprioception and resistance treating these biomechanical changes.
Detailed description
This study aims to determine the effects of FAKTR (functional and kinetic treatment with rehabilitation) therapy on muscle activity, ankle proprioception and foot biomechanics on over-pronated foot in patients with chronic non-specific low back pain. This study will be a Randomized Controlled trial and will be conducted on sample size of 60 patients, will be taken by consecutive sampling techniques. Patients will be randomly assigned into two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy: | Experimental | Combination Product: Traditional Physical Therapy |
| Traditional Physical Therapy + FAKTR | Active comparator | Combination Product: Traditional Physical Therapy + FAKTR |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25-45
- Both males and females
- History of three or more occurrences of lower back pain in the year before the study. - The diagnosis is confirmed by the pain experienced between the inferior gluteal folds and the costal margins.
- Moderate to severe pain is measured using a Numerical pain rating scale.
- Foot Posture Index score higher than +6. A total score ranging from -12 to +12 is obtained by measuring the subject's six feet using the Foot Posture Index (FPI). The following are the reference values for the posture of the feet: A neutral position is indicated by 0 to +5, a pronated position by +6 to +9, a hyper-pronated position by +10 to +12, a supinated position by -1 to -5, and a very supinated position by -6 to - 12.
Key exclusion criteria (6 listed)
- No recent history of lower limb fractures or injuries
- No history of surgical treatment experience for spinal stenosis, spina bifida, or disc herniation
- No neurological issues or constriction of the nerve roots.
- Previously diagnosed with Osteoporosis.
- SIJ dysfunction evaluated by Compression test positive
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 |
|---|---|---|
| Traditional Physical TherapyShort foot exercises. Towel-curl exercise. Heel raise exercise. Calf stretch. | Combination product | Traditional Physical Therapy: |
| Traditional Physical Therapy + FAKTRShort foot exercises. Towel-curl exercise. Heel raise exercise. Calf stretch. FAKTR Functional and Kinematic Treatment with Rehabilitation) technique: The FAKTR (Functional and Kinematic Treatment with Rehabilitation) technique applied is a modified IASTM technique in the pain-provocative position (incorporating static positions, motions, functional movements, resistance, and proprioceptive positions). | Combination product | Traditional Physical Therapy + FAKTR |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 18 Months
This scale will be used to determine the participant's pain threshold. This scale has a 0 to 10 range. The pain scale goes from zero (no pain) to ten (highest agony). High test-retest reliability has been demonstrated using NPRS (r = 0.96 and 0.95, respectively)
Balance of the Error Scoring System (BESS)
Time frame: 18 Months
The BESS incorporates three stances-double, single, and tandem-to assess static balancing skills. It takes 20 seconds to accomplish each stance. In the BESS, a participant's score is determined by how many mistakes they make; each mistake is worth one point. Opening the eyes, stepping, stumbling, falling, staying out of position for more than five seconds, shifting the hip into more than 30 degrees of flexion or abduction, elevating the forefoot or heel, and lifting the hands of the iliac crests are all examples of potential mistakes. Each posture is permitted to have a maximum of 10 points. A contestant will receive a maximum score of 10 for that stance if they are unable to hold it for five seconds. The total score of the BESS ranges from 0 to 60 and is calculated as the sum of the error points given for each of the six stances.
Oswestry Disability Index (ODI)
Time frame: 18 Months
The Oswestry Handicap Index, also known as the Oswestry Low Back Pain Disability Questionnaire, is a very crucial instrument to assess a patient's functional disability over the long term. The evaluation is regarded as the "gold standard" for measuring low-back functional results. The final score/index is on a scale of 0 to 100. Scores range from 0 to 20 for mild impairment, 21 to 60 for severe disability, 61 to 80 for crippled, and 81 to 100 for bed bound.
Valgus angle by goniometer
Time frame: 18 Months
The hindfoot valgus angle, also known as the valgus angle behind the ankle, is calculated by drawing a line between the midline of the heel and the midline of the lower part of the leg when the participant is in prone lying. After the procedure, the participant will be instructed to stand up, and the angle will be measured once more using a goniometer. Overpronation is defined as a value greater than nine, with 180 degrees being the usual angle. The reliability for angle dorsiflexion is 0.12-0.73 ICC, and the validity is 0.51-0.83
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 16 Jul 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Traditional Physical Therapy + FAKTR in people with Low Back Pain, run by Superior 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (time frame: 18 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.