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Active Not RecruitingNCT06983457

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
Superior University · Academic / Other
Sex
All
Age
30 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTTherapeutic 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_PRODUCTShockwave 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.

Timeline

Start date
2025-03-20
Primary completion
2025-06-20
Completion
2026-02-20
First posted
2025-05-21
Last updated
2025-05-21

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT06983457. Inclusion in this directory is not an endorsement.