- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441044
Graston With and Without Foot Insoles in Patients With Plantar Fasciitis
Comparative Effects of Graston With and Without Foot Insoles on Pain, Range of Motion and Functional Disability in Patients With Plantar Fasciitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Numerous interventions have been utilized for treatment of plantar fasciitis, which include, heat, cryotherapy, non-steroidal anti-inflammatory drugs, heel pads/cups, night splints, Graston tool, foot insoles, low-dye arch taping, plantar fascia specific stretching, calf stretching, steroid injection, extracorporeal shock wave therapy, platelet-rich plasma injection,and myofascial trigger point therapy.
The study will investigate the combined effect of Graston and foot insoles in the patients with plantar fasciitis. Through a randomized control trial Group A will receive Graston technique and foot insole along with standard physical therapy. (Ice pack for 10 minutes, TENS, static stretching of calf muscles and plantar fascia, strengthening exercises for intrinsic foot muscles and Group B will only receive Graston technique and standard physical therapy. Findings from this study could pave for more comprehensive and effective care for patients with plantar fasciitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 56700
- Riphah rehabilitation clinic Lahore.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients experiencing pain and functional limitation in their plantar fascia
- Patients with a history of 6 weeks or more.
- NPRS 3 to 7
- ≥ 2 degree calcaneous eversion
- Pain localized to medial calcaneal tuberosity
- Increase in heel pain on toe standing
- Positive windlass sign
Exclusion Criteria:
• Patients will be excluded if they are diagnosed with the following conditions;
- Ankle sprain
- Any fracture
- Autoimmune disorder
- Congenital disorder
- Cancer
- Osteoarthritis
- Rheumatoid arthritis
- Structural deformity
- Patient who have undergone fascia release surgery within 3 months prior to study.
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 |
|---|---|
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Experimental: Graston technique with foot insole.
Participants receive Graston technique and foot insole followed by strengthning of intrinsic foot muscles along with standard physical therapy.
(Ice pack for 10 minutes, TENS, static stretching of calf muscles and plantar fascia).
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Graston technique will be given (for approximately 8 minutes; 60 to 70 strokes/minute with a 5- to 10-second rest interval) at a 60° angle on the sole of the foot without exceeding the participant's comfort level. Patients will use these insoles 6 hours a day and 7 days a week. Participants will get 3 sessions per week for 8 weeks(24 sessions). |
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Active Comparator: Graston technique without foot insole.
Participants only receive Graston technique and standard physical therapy.
TENS for 10 minutes, Static stretching of plantar fascia and Ice pack for 10 minutes.
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Participants receive following treatment protocol Static stretching, TENS for 10 minutes, Graston assisted soft tissue mobilization and Ice pack for 10 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Time Frame: 8 weeks
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The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool in healthcare to assess a patient's pain intensity.
It allows individuals to self-report their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents the "worst possible pain."
The scale is divided into categories, with 1-3 indicating mild pain, 4-6 representing moderate pain, and 7-10 corresponding to severe pain (17).
This rating system helps healthcare providers understand a patient's pain level, enabling them to monitor changes over time and evaluate the effectiveness of various treatments.
By providing a consistent and quantifiable measure of pain, the NPRS plays an important role in managing chronic pain, aiding in the treatment of musculoskeletal conditions.
NPRS scores has a test-retest reliability of 0.61 to 0.88
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8 weeks
|
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Universal Goniometer
Time Frame: 8 weeks
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A Goniometer is a tool commonly used in physical therapy and orthopedics to measure joint range of motion (ROM), aiding in the assessment of flexibility and identifying movement limitations.
This device typically consists of two arms-a stationary arm and a movable arm-connected at a central axis with a degree scale for accurate readings.
Various types of Goniometer serve specific needs, including the universal goniometer for larger joints, a finger goniometer for smaller joints, inclinometers for spinal measurements, and digital versions for precise digital readouts.
To use a goniometer, a clinician aligns its axis with the joint, positioning one arm along the fixed part of the body and the other along the moving limb, then records the degree at the endpoint of ROM.
Goniometers are essential for monitoring recovery progress, setting rehabilitation goals, and ensuring effective treatment planning (18).
Correlation coefficient (ICC) of ankle angle values is (dorsiflexion = 0.96).
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8 weeks
|
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Foot and ankle disability index (FADI)
Time Frame: 8 weeks
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The FADI specific questionnaire for foot and ankle consists in a total of 26 items, grouped into three different categories of questions: 16 items (1-16) related to walking, 6 items (17-22) to daily activity and 4 (23-26) to pain.
Each item can be scored on a 5-points Likert scale (from zero to four), with a maximum total score of 104 points; the score can be transformed into percentage if a comparison with other questionnaires is needed.
The best possible score (104) corresponds to compete absence of any difficulty in daily activities and no pain; the minimum score of zero (0) corresponds to the worst possible condition i.e. severe limitation in walking and daily activities as well as pain presence.
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8 weeks
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Modified Foot Health Status Questionnaire(FHSQ)
Time Frame: 8 weeks
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The FHSQ consists of 13 questions reflecting four foot health-related domains: pain (4questions), function (4 questions), footwear (3 questions), and general foot health (2 questions).
Each question (item) is scored on a 5-point Likert scale, and individual item scores are then re-coded, tabulated, and finally transformed to a scale ranging from 0 (indicating poorest foot health) to 100 (indicating best foot health) for each of the 4 domains.
The FHSQ demonstrates a high degree of content, criterion, and construct validity and high retest reliability, and has been used as an outcome measure in clinical trials for a range of foot disorders.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faiza Taufiq, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- S24C14G30032
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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