Comparative Effects of TherapeuticU and Shockwave Therapy on Pain and QOL in Patients With Chronic Heel Spur Pain

Not Applicable

Active, not recruiting

• Conditions: Heel Spur

• Registration Number: NCT06983457
• Lead Sponsor: Superior University

Brief 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. 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 Timeline

• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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	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.

Trial Locations

Locations (1)

Sehat Medical Complex, Hanjarwal campus; 🇵🇰 Lahore, Punjab, Pakistan