Heel SpurNCT06983457
Comparative Effects of TherapeuticU and Shockwave Therapy on Pain and QOL in Patients With Chronic Heel Spur Pain
A study testing Therapeutic ultrasound and Shockwave Therapy in people with Heel Spur, run by Superior University at 1 site in Pakistan.
Trial summary
This research aims to compare the effectiveness of therapeutic ultrasound (TUS) and extracorporeal shockwave therapy (ESWT) in managing chronic heel spur pain and improving patients' quality of life. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Heel Spur
- What is being tested?
- Therapeutic ultrasound and Shockwave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with chronic heel spur pain, confirmed through imaging studies (e.g., X-ray, ultrasound).
- Age range: 30-60 years. Both male and female included
- Chronic heel pain persisting for more than 1 month.
- Individuals with no prior surgical intervention for heel pain.
- Ability to provide informed consent and comply with the treatment protocol.
Who cannot join
- Presence of systemic inflammatory conditions such as rheumatoid arthritis or gout.
- History of previous steroid injection less than 6 weeks.
- prior NSAID treatment less than 1 week,
- Individuals with contraindications to ultrasound or shockwave therapy, such as pacemakers or implanted devices.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sehat Medical Complex, Hanjarwal campus
Lahore, Punjab Province
About this study
Official title: Comparative Effects of Therapeutics Ultrasound and Shockwave Therapy on Pain and Quality of Life in Patients With Chronic Heel Spur Pain. A Randomized Controlled Clinical Trial
This research aims to compare the effectiveness of therapeutic ultrasound (TUS) and extracorporeal shockwave therapy (ESWT) in managing chronic heel spur pain and improving patients' quality of life. Chronic heel spur pain, often associated with plantar fasciitis, is a debilitating condition that affects mobility and daily activities.
Read the detailed description
The study will be conducted at Sehat Medical Complex, Lahore, over 10 months, enrolling 60 participants diagnosed with chronic heel spur pain. They will be randomly assigned into two groups: one receiving therapeutic ultrasound (10 sessions over two weeks with a frequency of 1 MHz and intensity between 0.8-2.0 W/cm²) and the other undergoing shockwave therapy (five weekly sessions with 2500 shocks per session at increasing pressure levels from 2.5 to 3.5 bars). The effectiveness of these interventions will be evaluated using the Visual Analog Scale (VAS) for pain intensity, the Foot Function Index (FFI) for functional assessment, and for quality of life. Follow-up assessments will be conducted at baseline, after the intervention (week 4), and at week 8 to evaluate both short-term and sustained treatment effects.
- Conditions
- Heel Spur
- Being tested
- Therapeutic ultrasound, Shockwave Therapy
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasoundCombination product
Participants in Group A will receive therapeutic ultrasound (TUS) as the primary intervention for managing chronic heel spur pain. The TUS treatment will be administered using a frequency of 1 MHz, which is effective for targeting deeper tissues. The intensity will range from 0.8 to 2.0 W/cm², depending on patient tolerance, and will be applied in a continuous mode to maximize thermal effects. Each treatment session will last for 4 minutes, and Treatment sessions will be conducted daily Monday through Friday for a period of 2 weeks in a series of ten treatments. The TUS application will focus on the medial calcaneal tubercle and the surrounding inflamed soft tissues to reduce pain and promote tissue healing.
Shockwave TherapyCombination product
Group B (Shockwave therapy) Participants in Group B will receive extracorporeal shockwave therapy to perform the shock wave treatments, an apparatus generating a shock wave in a pneumatic manner was used, i.e., BTL-5000 SWT POWER + HIGH INTENSITY LASER 12 - to perform the shock wave treatments, an apparatus generating a shock wave in a pneumatic manner was used. Before starting the procedure, each patient was informed about the principles of the shock wave action and the possibility of side effects. Each of the project participants underwent a series of 5 treatments at 7-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic ultrasound | Experimental | Not described Receives: Combination Product: Therapeutic ultrasound |
| Shockwave Therapy | Experimental | Not described Receives: Combination Product: Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
A Visual Analogue Scale (VAS) is one of the pain rating scales. Pain intensity can be categorized based on VAS scores, with mild pain typically ranging from 1-3, moderate pain from 4-6, and severe pain from 7-10. Validity is 0.95% and reliability is 0.88%.
Foot Function Index (FFI):
A Foot Function Index (FFI) is to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Validity is 0.90% and reliability is 0.85%.
Measured: 12 Months
Quality Of Life
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel SpurStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983457
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/815
- Status last verified
- May 2025
- First submitted
- 29 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Therapeutics Ultrasound and Shockwave Therapy on Pain and Quality of Life in Patients With Chronic Heel Spur Pain. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06983457
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/815
- Conditions
- Heel Spur
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 21 May 2025 (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.
This research aims to compare the effectiveness of therapeutic ultrasound (TUS) and extracorporeal shockwave therapy (ESWT) in managing chronic heel spur pain and improving patients' quality of life. Chronic heel spur pain, often associated with plantar fasciitis, is a debilitating condition that affects mobility and daily activities.
Detailed description
The study will be conducted at Sehat Medical Complex, Lahore, over 10 months, enrolling 60 participants diagnosed with chronic heel spur pain. They will be randomly assigned into two groups: one receiving therapeutic ultrasound (10 sessions over two weeks with a frequency of 1 MHz and intensity between 0.8-2.0 W/cm²) and the other undergoing shockwave therapy (five weekly sessions with 2500 shocks per session at increasing pressure levels from 2.5 to 3.5 bars). The effectiveness of these interventions will be evaluated using the Visual Analog Scale (VAS) for pain intensity, the Foot Function Index (FFI) for functional assessment, and for quality of life. Follow-up assessments will be conducted at baseline, after the intervention (week 4), and at week 8 to evaluate both short-term and sustained treatment effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic ultrasound | Experimental | Combination Product: Therapeutic ultrasound |
| Shockwave Therapy | Experimental | Combination Product: Shockwave Therapy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with chronic heel spur pain, confirmed through imaging studies (e.g., X-ray, ultrasound).
- Age range: 30-60 years. Both male and female included
- Chronic heel pain persisting for more than 1 month.
- Individuals with no prior surgical intervention for heel pain.
- Ability to provide informed consent and comply with the treatment protocol.
Key exclusion criteria (4 listed)
- Presence of systemic inflammatory conditions such as rheumatoid arthritis or gout.
- History of previous steroid injection less than 6 weeks.
- prior NSAID treatment less than 1 week,
- Individuals with contraindications to ultrasound or shockwave therapy, such as pacemakers or implanted devices.
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 |
|---|---|---|
| Therapeutic ultrasoundParticipants in Group A will receive therapeutic ultrasound (TUS) as the primary intervention for managing chronic heel spur pain. The TUS treatment will be administered using a frequency of 1 MHz, which is effective for targeting deeper tissues. The intensity will range from 0.8 to 2.0 W/cm², depending on patient tolerance, and will be applied in a continuous mode to maximize thermal effects. Each treatment session will last for 4 minutes, and Treatment sessions will be conducted daily Monday through Friday for a period of 2 weeks in a series of ten treatments. The TUS application will focus on the medial calcaneal tubercle and the surrounding inflamed soft tissues to reduce pain and promote tissue healing. | Combination product | Therapeutic ultrasound |
| Shockwave TherapyGroup B (Shockwave therapy) Participants in Group B will receive extracorporeal shockwave therapy to perform the shock wave treatments, an apparatus generating a shock wave in a pneumatic manner was used, i.e., BTL-5000 SWT POWER + HIGH INTENSITY LASER 12 - to perform the shock wave treatments, an apparatus generating a shock wave in a pneumatic manner was used. Before starting the procedure, each patient was informed about the principles of the shock wave action and the possibility of side effects. Each of the project participants underwent a series of 5 treatments at 7-day intervals. | Combination product | Shockwave Therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12 Months
A Visual Analogue Scale (VAS) is one of the pain rating scales. Pain intensity can be categorized based on VAS scores, with mild pain typically ranging from 1-3, moderate pain from 4-6, and severe pain from 7-10. Validity is 0.95% and reliability is 0.88%. Foot Function Index (FFI): A Foot Function Index (FFI) is to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Validity is 0.90% and reliability is 0.85%.
Quality Of Life
Time frame: 12 Months
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultrasound and Shockwave Therapy in people with Heel Spur, run by Superior 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) (time frame: 12 Months). The study lists 2 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 21 May 2025.