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

NCT ID: NCT06983457

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-02-20

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.

Conditions

Heel Spur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Therapeutic ultrasound

Group Type: EXPERIMENTAL

Therapeutic ultrasound

Intervention Type: COMBINATION_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 Therapy

Group Type: EXPERIMENTAL

Shockwave Therapy

Intervention Type: COMBINATION_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.

Interventions

Therapeutic ultrasound

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.

Intervention Type: COMBINATION_PRODUCT

Shockwave Therapy

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sehat Medical Complex, Hanjarwal campus

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/815

Identifier Type: -

Identifier Source: org_study_id