NCT01510249

Brief Summary

Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel and it makes walking limited or even impossible. The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in patients with heel spur. The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel spur confirmed radiographically. The patients were randomly divided into two groups;in Group 1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock wave procedure(6 treatments). The researchers assessed pain three times (prior to the therapy, after the first and then the second week of treatment). In order to do this they used a modified form of the Laitinen pain indicators questionnaire (results expressed in points) and VAS - visual analogue scale (results given in milimeters). The results were statistically analyzed. In the studied periods of time a decrease in pain was observed (both in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both the groups after the first week of treatment. Ultrasound and shock wave therapies show a comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has an advantage over ultrasound therapy. A smaller number of procedures is required to obtain comparable results, which makes the therapy less expensive. No side effects were observed during and after the treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

December 16, 2011

Last Update Submit

January 13, 2012

Conditions

Keywords

calcaneal spurshock wave therapyultrasound therapy

Outcome Measures

Primary Outcomes (1)

  • A Comparison of the Analgesic Efficacies of Ultrasound and Shock Wave Therapy in the Patients With Calcaneal Spur

    two weeks in a series of 10 ultrasound treatments and 6 radial shock wave treatments

Eligibility Criteria

Age38 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was conducted on a group of 52 patients of both sexes, aged 38-86 years (mean 57.39; SD-11.5) with a plantar calcaneal spur confirmed by X-ray images. Patients were treated in the Department of Physical Medicine and Rehabilitation Day Unit of the University Hospital im. WAM - Central Veterans Hospital in Lodz and Municipal Health Clinic of Andrespol. In order to compare the effectiveness of the two forms of physiotherapy, ultrasound and radial shock wave therapy, the patients were randomly assigned (using a simple randomization) into two groups: * Group 1 - ultrasound therapy group: 22 patients aged 38-86 years (mean 58.64; SD-12.99), * Group 2 - radial shock wave group: 30 patients aged 40-71 years (mean 56.13; SD-10.02).

You may qualify if:

  • plantar calcaneal spur confirmed by X-ray images

You may not qualify if:

  • contraindications for physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heel Spur

Condition Hierarchy (Ancestors)

ExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Jolanta Krukowska, PhD

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physical Therapy

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 16, 2012

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

January 16, 2012

Record last verified: 2012-01