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A clinical trial to study the effect of foot orthoses and foot exercises in managing lower back pain in patients with flat foot

The Effectiveness of Foot Orthoses(FO) and Foot Exercises(FE) in the management of Lower Back Pain(LBP) in patients with Flexible Pes Planus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050247
Enrollment
88
Registered
2023-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M214- Flat foot [pes planus] (acquired) Health Condition 2: M545- Low back pain

Interventions

Intervention1: Foot Orthoses and Foot Exercises: Foot Orthoses ( Arch Support Pad Socks, available in market) - Standardized Silicon based Medial Longitudinal Arch Support(Freq- 6-8 hrs/day, Duration-

Sponsors

Varun Kumar R
Lead Sponsor
Dr N Thanappan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with lower back pain aged 20-60 years having unilateral or bilateral Flexible Pes Planus(Diagnosed using a wet foot print impression method and great toe extension test to differentiate it from Rigid Pes Planus)

Exclusion criteria

Exclusion criteria: a.pregnancy b.previous back or lower extremity surgery c.Any form of Physical Therapy (excluding exercises that promote good health) to prevent possible overlapping effects within this study from possible earlier treatment) e.Pathological cause of back pain screened through clinical Examination 1.Claudication distance( to rule out spinal stenosis and vascular insufficiency) 2.Any joint pain, swelling, joint line tenderness or warmth( to rule out arthritis) 3.Wake up several times during the night, severe stiffness in the back on waking up, history of inflammatory bowel disease( to rule out ankylosing spondylitis) 4.Positive Straight Leg Test ( to rule out herniated disc, prolapsed disc, spondylolisthesis)

Design outcomes

Primary

MeasureTime frame
% of patients with 60 % or more improvement in Quebec Pain Disability ScaleTimepoint: At the time of recruitment, After 8 week interval

Secondary

MeasureTime frame
Correlation between the talometatarsal angle(Determined using lateral x ray of foot) and the severity of pain on the Quebec Pain Disability ScaleTimepoint: At the time of recruitment

Countries

India

Contacts

Public ContactDr N Thanappan

Madurai Medical College

thanapps@gmail.com9442160708

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026