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NCT Number: NCT07441044

Graston With and Without Foot Insoles in Patients With Plantar Fasciitis

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.

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah rehabilitation clinic Lahore.

Lahore, Punjab Province, 56700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: 8 weeks

    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

  2. Universal Goniometer

    Time frame: 8 weeks

    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).

  3. Foot and ankle disability index (FADI)

    Time frame: 8 weeks

    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.

  4. Modified Foot Health Status Questionnaire(FHSQ)

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Graston With and Without Foot Insoles on Pain, Range of Motion and Functional Disability in Patients With Plantar Fasciitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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