- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544901
Navicular Mobilization in Patients of Planter Fasciitis
Navicular Mobilization With and Without Conventional Physical Therapy in Patients of Planter Fasciitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
• Screening: Participants who meet the inclusion criteria will be recruited using a convenient sampling technique. This involves selecting participants who are readily available and willing to participate in the study.
• Allocation: Eligible participants will be screened and informed about the study including its purpose, procedures, potential risks and benefits. Informed consent will be obtained from each participant prior to their formal enrolment in the study.
• Randomization: Following the baseline assessment, the randomization was conducted using the Online Randomizer tool (https://www.randomizer.org/). By specifying the group numbers, participants per group, and the total participants, unique identification numbers were generated for each participant.
• Blindness: This study a single blinded, the patients were kept blinded about the study.
• Intervention Group A: The participants randomly allocated in Group A will receive navicular mobilization. In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it. By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided. This dorsal glide will be given with 2 sets of 5 minutes. Each session will be of 30 minutes. Four sessions will be given per week for 4 weeks.
Group B: The participants randomly allocated in Group B will receive conventional physical therapy with navicular mobilization. In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it. By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided. This dorsal glide will be given with 2 sets of 5 minutes. In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes .These exercises will be performed in a set of 3 with 12 repetitions in each set in one session. This treatment session will be of 30 minutes and will be give 4 session per week for 4 weeks.
Outcome Variables:
- Pain (Numeric Pain Rating Scale)
- Disability (Foot Function Index)
- Navicular height drop (Navicular drop test)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 55150
- University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants between 18 to 32 years of age.
- Plantar fasciitis with flat foot.
- Positive Flat foot cases diagnosed with foot print measurement
- Both males and females
- Unilateral or bilateral involvement with chronic plantar fasciitis
- Diagnosed case of plantar fasciitis will be taken with navicular drop
- Navicular Drop (ND) of > 10mm
Exclusion Criteria:
- Patients with Peripheral vascular diseases
- Patients with History of fractures in the lower limb
- Patients with Skin infections and wounds on the foot
- Patients with any neurological deficit involving foot
- Patients with a history of foot or ankle surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Navicular Mobilization
In navicular mobilization, Subject- prone lying, Therapist- standing on tested side.
In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered.
The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
|
In navicular mobilization, Subject- prone lying, Therapist- standing on tested side.
In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered.
The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes .
|
|
Experimental: Conventional physical therapy + Navicular Mobilization
In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes.In navicular mobilization, Subject- prone lying, Therapist- standing on tested side.
In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered.
The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
|
In navicular mobilization, Subject- prone lying, Therapist- standing on tested side.
In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered.
The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Function Index
Time Frame: Baseline, 3rd week, 6th week
|
Foot function index is a questionnaire used to assess pathological impact on foot with respect to disability, limitations of activity and pain.
It consists of 23 questions which are sub divided into three sub scales.
These three sub scales are pain, activity limitation and disability.
It's scoring is done by adding these scales which range is from 0 to 100.
Minimum score is 0 and maximum is 100.
Where 0 shows no pain and 100 shows worst pain.
During the initial administration of the questionnaire, Cronbach's alpha was determined to be = 0.78 for the FFI total score while the subscales ranged from 0.80 to 0.61
|
Baseline, 3rd week, 6th week
|
|
Numeric Pain Rating Scale
Time Frame: Baseline, 3rd week, 6th week
|
Numeric rating scales consist of a series of numbers rating pain intensity, typically from 0 to 10 or with 0 being "no pain" and 10 "the worst pain imaginable."
|
Baseline, 3rd week, 6th week
|
|
Navicular drop test
Time Frame: Baseline, 3rd week, 6th week
|
Navicular drop test is used to measure static foot assessment in Sagittal plane of navicular tuberosity in neutral state.
The tuberosity of the navicular bone is measured in neutral position, relaxed and stance position.
Supinated foot showed less than 5mm, neutral foot shows range from 6 to 8mm or 5 to 9mm and pronated foot shows reading from greater than 10 to 15 or greater than 9mm.
All testers' measurements of showed high levels of intra- and inter-rater reliability (ICC = 0.83 to 0.95) of navicular drop test.
|
Baseline, 3rd week, 6th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asim Arif, Phd scholar, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UOL/IREB/25/09/0049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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