Graston With and Without Foot Insoles in Patients With Plantar Fasciitis

NCT07441044 | Completed

• 1 other identifier: S24C14G30032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Plantar fasciitis is the most common causes of heel pain, especially in older adults. About 2 million people are treated for this specific disease every year. Plantar fascia is an aponeurosis which maintains the arches on the plantar side of the foot.It runs all the way from tuberosity of calcaneal bone to heads of metatarsal bones. It consist of thick fibrous multi-layer connective tissue located on the planter side of the foot. Its inflammation is what is called plantar fasciitis. Plantar fasciitis has same pathophysiology as of tennis elbow at the foot, in which foot is exposed to repetitive micro trauma at your heel bone insertion of fascia. At night, foot usually adapt plantar flexed posture and after a long period of inactivity when patient touches ground after rising from bed, foot goes into dorsiflexion during walking.

Conditions

Heel Spur Syndrome; Plantar Fasciitis of Both Feet

Keywords

Graston; Heel spur syndrome; Foot insoles; Plantar Fasciitis; Foot arch supports

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

  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

  8 weeks

• Universal Goniometer

  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).

  8 weeks

• Foot and ankle disability index (FADI)

  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.

  8 weeks

• Modified Foot Health Status Questionnaire(FHSQ)

  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.

  8 weeks

Study Arms (2)

Graston technique with foot insole.

EXPERIMENTAL

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).

Other: Graston with foot insole.

Graston technique without foot insole.

ACTIVE COMPARATOR

Participants only receive Graston technique and standard physical therapy. TENS for 10 minutes, Static stretching of plantar fascia and Ice pack for 10 minutes.

Other: Graston without insole.

Interventions

Graston with foot insole. OTHER

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).

Graston technique with foot insole.

Graston without insole. OTHER

Participants receive following treatment protocol Static stretching, TENS for 10 minutes, Graston assisted soft tissue mobilization and Ice pack for 10 minutes.

Graston technique without foot insole.

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah rehabilitation clinic Lahore.

Lahore, Punjab Province, 56700, Pakistan

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Faiza Taufiq

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will receive Graston technique and foot insole followed by strengthning of intrinsic foot muscles.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: January 15, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)