NCT06584721

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

October 2, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

September 2, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

Short foot exercisesFoot hyper-pronationlow back painAnti-pronation Taping

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    4 weeks

Study Arms (2)

Anti-pronation taping (Low dye taping) + Conventional therapy

ACTIVE COMPARATOR

Anti-pronation taping and conventional

Other: Anti-pronation taping (Low dye taping) + Conventional therapy

Short Foot Exercises + Conventional Study

OTHER

Short foot exercises + Conventional therapy

Other: Short Foot Exercises + Conventional PT

Interventions

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.

Anti-pronation taping (Low dye taping) + Conventional therapy

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.

Short Foot Exercises + Conventional Study

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal Surgical Hospital, Nawababad, Wah Cantt

Wāh, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kinza Anwar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 5, 2024

Study Start

October 2, 2024

Primary Completion

August 27, 2025

Study Completion

August 27, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations