Heel Spur SyndromeNCT07441044
Graston With and Without Foot Insoles in Patients With Plantar Fasciitis
A study testing Graston with foot insole. and Graston without insole. in people with Heel Spur Syndrome and Plantar Fasciitis of Both Feet, run by Riphah International University at 1 site in Pakistan.
Trial 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 Apo neurosis which maintains the arches on the plantar side of the foot. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heel Spur Syndrome, Plantar Fasciitis of Both Feet
- What is being tested?
- Graston with foot insole. and Graston without insole.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • Patients will be excluded if they are diagnosed with the following conditions;
- Ankle sprain
- Any fracture
- Autoimmune disorder
- Congenital disorder
- Cancer
Show all 10Show fewer
- Osteoarthritis
- Rheumatoid arthritis
- Structural deformity
- Patient who have undergone fascia release surgery within 3 months prior to study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah rehabilitation clinic Lahore.
Lahore, Punjab Province, 56700
About this study
Official title: Comparative Effects of Graston With and Without Foot Insoles on Pain, Range of Motion and Functional Disability 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 Apo neurosis 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.
Read the 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.
- Conditions
- Heel Spur Syndrome, Plantar Fasciitis of Both Feet
- Being tested
- Graston with foot insole., Graston without insole.
- Keywords
- Graston, Heel spur syndrome, Foot insoles, Plantar Fasciitis, Foot arch supports
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Graston without insole. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Jan 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Spur SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive Graston technique and foot insole followed by strengthning of intrinsic foot muscles.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441044
- Sponsor's protocol ID
- S24C14G30032
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Graston With and Without Foot Insoles on Pain, Range of Motion and Functional Disability in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07441044
- Acronym / sponsor ID
- S24C14G30032
- Conditions
- Heel Spur Syndrome, Plantar Fasciitis of Both Feet
- Keywords
- Graston, Heel spur syndrome, Foot insoles, Plantar Fasciitis, Foot arch supports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Apo neurosis 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive Graston technique and foot insole followed by strengthning of intrinsic foot muscles.
| Arm | Type | Receives |
|---|---|---|
| Graston technique with foot insole. | Experimental | Other: Graston 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). |
| Graston technique without foot insole. | Active comparator | Other: Graston without 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- • Patients will be excluded if they are diagnosed with the following conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graston with foot insole.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). | Other | Graston technique with foot insole. |
| Graston without insole.Participants receive following treatment protocol Static stretching, TENS for 10 minutes, Graston assisted soft tissue mobilization and Ice pack for 10 minutes. | Other | Graston technique without foot insole. |
Primary outcome
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
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Heel Spur Syndrome
Recruiting
Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial
Heel Spur Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faiza Taufiq principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston with foot insole. and Graston without insole. in people with Heel Spur Syndrome and Plantar Fasciitis of Both Feet, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.