Low Back PainNCT06584721
Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation
A study testing Anti-pronation taping (Low dye taping) + Conventional therapy and Short Foot Exercises + Conventional PT in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture. 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?
- Anti-pronation taping (Low dye taping) + Conventional therapy and Short Foot Exercises + Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2024to 27 Aug 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Age 25 to 45 years
- Foot hyper pronation (FPI ≥ +6)
- low back pain > 3months (Pain, muscle stiffness, and muscle tension between lower costal margin and inferior gluteal fold)
- Low back pain with NPRS ≥ 3
Who cannot join
- Acute trauma or fracture of foot/ back (last 3 months)
- leg length discrepancy >5mm
- Diagnosed with Spondylolisthesis, spondylitis
- Diagnosed with Lumbar radiculopathy, stenosis, fibromyalgia, plantar fasciitis
- Recent History of fall < 3months
- Congenital hyper-pronation of foot
- Pregnancy
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
Rawal Surgical Hospital, Nawababad, Wah Cantt
Wāh, Punjab Province
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
SUNBAL FATIMA, +92-331-5407503)
About this study
Official title: Comparison of Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation of Foot
The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture.
Read the detailed description
Low back pain is a musculoskeletal symptom which occur in all ages during life time with acute episode or chronic condition. Total of 619 million people are living with low back pain worldwide. Low back pain is the musculoskeletal condition that involves pain in region below costal margin and above inferior gluteal fold, along with pain there is also stiffness, limitation of range of motion, aggravated by movement and affected ability to perform daily life activities. Frequency and severity of low back pain are related to spinal loading that increase the strain on lumbar spine, these loads shift from foot (during heel strike) to leg and ultimately to the back.
Abnormal mechanical loading of lumbar spine due to poor postural control or muscular weakness is considered as risk factor for low back pain. The ability of ankle complex to provide stabilization and mobilization depends upon plantar pressure distribution. In particular, pronated foot causes internal rotation of tibia along with internal rotation of hip that cause femoral ante-version and increase in lumbar lordosis and deteriorate lumbopelvic alignment resulting in low back pain Short foot exercise (SFE) is considered more effective in terms of postural balance and excessive pronation. SFE is a widely used intervention that has been developed recently to improve ankle proprioception and global movement pattern, so as to elevate and support the medial longitudinal arch of the foot and to improve dynamic standing balance Anti-pronation taping is a technique that stimulate underlying sensory receptor either through the surface contact or stretch of skin that causes the sensory input to central nervous system to be altered hence it ultimately influences the execution and perception of movement. Low dye taping is effective in correcting over-pronated foot and also increase navicular height along with increase in reactive strength index. low dye taping not only improve arch height but also improves muscular activity The rationale for the use of these techniques is to compare the effect of short foot exercises and anti-pronation taping on low back pain associated with hyper-pronated foot and also on range of motion of foot and back along with the foot posture.
- Conditions
- Low Back Pain
- Being tested
- Anti-pronation taping (Low dye taping) + Conventional therapy, Short Foot Exercises + Conventional PT
- Keywords
- Short foot exercises, Foot hyper-pronation, low back pain, Anti-pronation Taping
- 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.
Anti-pronation taping (Low dye taping) + Conventional therapyOther
They would be receiving treatment as follow:
Anti-pronation taping (Low dye taping) Applied on alternate days. 3 days / week for 4 weeks.
Conventional Therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 20 mins 2. William flexion exercises (5repsx1set). 3. Lower limb stretching exercises (3repsxset1, 10sec hold) 3sessions/ week.
Short Foot Exercises + Conventional PTOther
They would be receiving treatment as follow:
Short foot exercises are used to reduce the foot pronation: Frequency: 30 reps x 1 set, 30 sec hold and 10 sec relaxation for 4 weeks. 3 session/ week).
Short foot Exercises includes a four-week plan, 1- Shortening of foot in Anterior-posterior direction, 2- Increase medial longitudinal arch, 3- Balanced loading in standing, 4- Approximating Head of first, second meta-tarsal and calcaneus with patient in standing (single leg).
Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 20 mins 2. William flexion exercises (5repsx1set). 3. Lower limb stretching exercises (3repsx1set, 10sec hold) 3sessions/ week.
| Study group | Role | What they receive |
|---|---|---|
| Anti-pronation taping (Low dye taping) + Conventional therapy | Active comparator | Anti-pronation taping and conventional Receives: Other: Anti-pronation taping (Low dye taping) + Conventional therapy |
| Short Foot Exercises + Conventional Study | Other | Short foot exercises + Conventional therapy Receives: Other: Short Foot Exercises + Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (Goniometer)
It is a tool used to measure the range of motion of joint (0-180). Record the starting measurement, remove the goniometer, and allow the patient to move the joint through the available range of motion. Replace and realign the goniometer. Read and record the measurement.
Measured: 4 weeks
Numeric Pain Rating Scale NPRS
The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain.
Measured: 4 weeks
Foot Posture Index
It is a tool which provides quantitative data about foot posture. It has total six items. Talar head palpation, observation of curves above and below the lateral malleolus, a bulge in the region of the talonavicular joint, eversion and inversion of the calcaneus, congruence of the medial longitudinal arch, adduction and abduction of the forefoot in relation to the rear foot. Total score between (- 12 and + 12). (0 and + 5 normal feet) ;( + 6 to + 9 pronated feet) ;( ≥ + 10 highly pronated feet) ;( - 1 to - 4 supinated feet); - 5 to - 12 indicate highly supinated.
Measured: 4 weeks
Oswestry Disability Index
The ODQ scale was utilized to quantify the limitations in regular daily life activities. It depends on 10 segments with six levels each, evaluating the restriction of different activities of day to day living. The qualities range from 0 (the best wellbeing state) to 100 (the most worsening wellbeing state). For each segment of the poll, the absolute plausible score is 5.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start2 Oct 2024
- Primary completion27 Aug 2025 (estimated)
- Study completion27 Aug 2025 (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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinza Anwar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584721
- Sponsor's protocol ID
- REC/01876 Sunbal Fatima
- Status last verified
- Feb 2025
- First submitted
- 2 Sep 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation of Foot
- ClinicalTrials.gov ID
- NCT06584721
- Acronym / sponsor ID
- REC/01876 Sunbal Fatima
- Conditions
- Low Back Pain
- Keywords
- Short foot exercises, Foot hyper-pronation, low back pain, Anti-pronation Taping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 27 Aug 2025 (estimated)
- Study completion
- 27 Aug 2025 (estimated)
- First posted
- 5 Sep 2024 (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.
The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture.
Detailed description
Low back pain is a musculoskeletal symptom which occur in all ages during life time with acute episode or chronic condition. Total of 619 million people are living with low back pain worldwide. Low back pain is the musculoskeletal condition that involves pain in region below costal margin and above inferior gluteal fold, along with pain there is also stiffness, limitation of range of motion, aggravated by movement and affected ability to perform daily life activities. Frequency and severity of low back pain are related to spinal loading that increase the strain on lumbar spine, these loads shift from foot (during heel strike) to leg and ultimately to the back.
Abnormal mechanical loading of lumbar spine due to poor postural control or muscular weakness is considered as risk factor for low back pain. The ability of ankle complex to provide stabilization and mobilization depends upon plantar pressure distribution. In particular, pronated foot causes internal rotation of tibia along with internal rotation of hip that cause femoral ante-version and increase in lumbar lordosis and deteriorate lumbopelvic alignment resulting in low back pain Short foot exercise (SFE) is considered more effective in terms of postural balance and excessive pronation. SFE is a widely used intervention that has been developed recently to improve ankle proprioception and global movement pattern, so as to elevate and support the medial longitudinal arch of the foot and to improve dynamic standing balance Anti-pronation taping is a technique that stimulate underlying sensory receptor either through the surface contact or stretch of skin that causes the sensory input to central nervous system to be altered hence it ultimately influences the execution and perception of movement. Low dye taping is effective in correcting over-pronated foot and also increase navicular height along with increase in reactive strength index. low dye taping not only improve arch height but also improves muscular activity The rationale for the use of these techniques is to compare the effect of short foot exercises and anti-pronation taping on low back pain associated with hyper-pronated foot and also on range of motion of foot and back along with the foot posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-pronation taping (Low dye taping) + Conventional therapy | Active comparator | Other: Anti-pronation taping (Low dye taping) + Conventional therapyAnti-pronation taping and conventional |
| Short Foot Exercises + Conventional Study | Other | Other: Short Foot Exercises + Conventional PTShort foot exercises + Conventional therapy |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender
- Age 25 to 45 years
- Foot hyper pronation (FPI ≥ +6)
- low back pain > 3months (Pain, muscle stiffness, and muscle tension between lower costal margin and inferior gluteal fold)
- Low back pain with NPRS ≥ 3
Key exclusion criteria (7 listed)
- Acute trauma or fracture of foot/ back (last 3 months)
- leg length discrepancy >5mm
- Diagnosed with Spondylolisthesis, spondylitis
- Diagnosed with Lumbar radiculopathy, stenosis, fibromyalgia, plantar fasciitis
- Recent History of fall < 3months
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 |
|---|---|---|
| Anti-pronation taping (Low dye taping) + Conventional therapyThey would be receiving treatment as follow: Anti-pronation taping (Low dye taping) Applied on alternate days. 3 days / week for 4 weeks. Conventional Therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 20 mins 2. William flexion exercises (5repsx1set). 3. Lower limb stretching exercises (3repsxset1, 10sec hold) 3sessions/ week. | Other | Anti-pronation taping (Low dye taping) + Conventional therapy |
| Short Foot Exercises + Conventional PTThey would be receiving treatment as follow: Short foot exercises are used to reduce the foot pronation: Frequency: 30 reps x 1 set, 30 sec hold and 10 sec relaxation for 4 weeks. 3 session/ week). Short foot Exercises includes a four-week plan, 1- Shortening of foot in Anterior-posterior direction, 2- Increase medial longitudinal arch, 3- Balanced loading in standing, 4- Approximating Head of first, second meta-tarsal and calcaneus with patient in standing (single leg). Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 20 mins 2. William flexion exercises (5repsx1set). 3. Lower limb stretching exercises (3repsx1set, 10sec hold) 3sessions/ week. | Other | Short Foot Exercises + Conventional Study |
Primary outcome
Range of motion (Goniometer)
Time frame: 4 weeks
It is a tool used to measure the range of motion of joint (0-180). Record the starting measurement, remove the goniometer, and allow the patient to move the joint through the available range of motion. Replace and realign the goniometer. Read and record the measurement.
Numeric Pain Rating Scale NPRS
Time frame: 4 weeks
The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain.
Foot Posture Index
Time frame: 4 weeks
It is a tool which provides quantitative data about foot posture. It has total six items. Talar head palpation, observation of curves above and below the lateral malleolus, a bulge in the region of the talonavicular joint, eversion and inversion of the calcaneus, congruence of the medial longitudinal arch, adduction and abduction of the forefoot in relation to the rear foot. Total score between (- 12 and + 12). (0 and + 5 normal feet) ;( + 6 to + 9 pronated feet) ;( ≥ + 10 highly pronated feet) ;( - 1 to - 4 supinated feet); - 5 to - 12 indicate highly supinated.
Oswestry Disability Index
Time frame: 4 weeks
The ODQ scale was utilized to quantify the limitations in regular daily life activities. It depends on 10 segments with six levels each, evaluating the restriction of different activities of day to day living. The qualities range from 0 (the best wellbeing state) to 100 (the most worsening wellbeing state). For each segment of the poll, the absolute plausible score is 5.
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Kinza Anwar, MS 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 Anti-pronation taping (Low dye taping) + Conventional therapy and Short Foot Exercises + Conventional PT 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 5 inclusion and 7 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 21 Feb 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 Kinza Anwar, MS (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (Goniometer) (time frame: 4 weeks). 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 21 Feb 2025.