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

NCT06983457 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/815
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Spur

Outcome Measures

Primary Outcomes (2)

• 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%.

  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.

  12 Months

Study Arms (2)

Therapeutic ultrasound

EXPERIMENTAL

Combination Product: Therapeutic ultrasound

Shockwave Therapy

EXPERIMENTAL

Combination Product: Shockwave Therapy

Interventions

Therapeutic ultrasound 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.

Therapeutic ultrasound

Shockwave Therapy 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.

Shockwave Therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Sehat Medical Complex, Hanjarwal campus

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Ultrasonic Therapy; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: May 21, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)