- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907085
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
April 5, 2019 updated by: Hilal Yeşil
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur: a Double Blind, Placebo-controlled Study
The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this study was to evaluate the effect of high-intensity laser therapy (HILT) and exercise in patients with calcaneal spur.
The patients were randomly assigned to receive either HILT + exercise (n=21) or placebo HILT + exercise (n=21).
Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS) ), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement (with pedobarographic assesment), and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Eyalet/Yerleşke
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Afyon, Eyalet/Yerleşke, Turkey, 0300
- Hilal Yeşil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligible patients aged 30-75 years old with pain in the plantar region lasting for at least one month, who were sensitive to palpation and who were diagnosed with a calcaneal spur in the subcalcaneal region as shown in a lateral x-ray of the foot were included in the study.
Exclusion Criteria:
- Patients with any sign of pathology in the blood count, with an increased sedimentation rate, having undergone any physical therapy for calcaneal spur within the past six months and/or local anesthesia and/or steroid injection in the region of pain, with the presence of a pathology on the x-ray apart from calcaneal spur, pregnancy, with the presence of systemic inflammatory disease, and with a history of local trauma or a history previous HILT therapy were excluded from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High intensity laser therapy (HILT) + exercise
Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions.
A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist.
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High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions.
A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist.
Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes.
The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles.
The patients were also taught to collect the foot and towel.
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Placebo Comparator: Placebo HILT + exercise
Placebo therapy was applied in five sessions a week for three weeks, with a total of 15 sessions a day, with no current flowing through the device.
This was followed by the exercise programs described above, performed once a day with the physiotherapist.
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Placebo HILT group; Placebo therapy was applied in five sessions a week for three weeks, with a total of 15 sessions a day, with no current flowing through the device.
This was followed by the exercise programs described above, performed once a day with the physiotherapist.
Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes.
The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles.
The patients were also taught to collect the foot and towel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline visual analog scale (VAS) at 4th and 12th week.
Time Frame: up to 12 weeks
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The patients were asked to make an assesment of their pain between 4-12 weeks.
The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).
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up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks.
Time Frame: Up to12 weeks
|
This is a self-administered scale, which is widely used to measure the quality of life.
It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases.
SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.
Total score was between 0 (no disability) and 100 (disability).
Every subgroup of the questionnaire has a score scale between 0 and 100.
Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
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Up to12 weeks
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Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th weeks
Time Frame: Up to12 weeks
|
The assessment of level of functionality; was performed by Foot and Ankle Outcome Score (FAOS), which contains five subscales and which is used for the evaluation of the symptoms, pain, work-daily life, sports and recreational activities, and quality of life of patients.
Each question is scored on a 5-point Likert scale (from 0 to 4), and each of the 5 subscale scores is calculated by adding the included subscale items.
The raw scores are then transformed into a final score of 0 to 100 (from worst to best outcomes).
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Up to12 weeks
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Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks.
Time Frame: up to 12 weeks
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General pain level assessment, performed using the Roles and Maudsley Pain Score, in which 1 point (excellent): no pain, full ROM and activity; 2 points (good): sometimes discomfort, full ROM and activity; 3 points (moderate): some pain after long-lasting activity; and 4 points (poor): activity-limiting pain.
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up to 12 weeks
|
Change from baseline static and dynamic pedobarographic evaluations at 4th and 12th weeks.
Time Frame: up to 12 weeks
|
The plantar pressure measurement assessment was made using a pedograph (RSscan International, Olen, Belgium), and static and dynamic pedobarographic evaluations were made of all patients.
For the dynamic measurement, the patient was placed on a walking platform on which the pedobarography was hidden, and was made to walk on the platform twice to obtain the normal walking speed and rhythm before measurement, and five times during the measurement.
For the static measurement, the patient was placed on the pedobarograph, and the platform pressure of both feet, the upright posture of the patients, and the symmetry and parallelism of the shoulders and feet were all maintained.
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up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYHILT2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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