Back to resultsThe Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
Primary Purpose
Calcaneal Spur
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
HILT + exercise
Placebo HILT + exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Calcaneal Spur focused on measuring HILT, calcaneal spur, placebo
Eligibility Criteria
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
Sites / Locations
- Hilal Yesil
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High intensity laser therapy (HILT) + exercise
Placebo HILT + exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline visual analog scale (VAS) at 4th and 12th week.
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).
Secondary Outcome Measures
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th 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.
Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th 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).
Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks.
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.
Change from baseline static and dynamic pedobarographic evaluations at 4th and 12th 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03907085
Brief Title
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
Official Title
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur: a Double Blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hilal Yeşil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneal Spur
Keywords
HILT, calcaneal spur, placebo
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity laser therapy (HILT) + exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo HILT + exercise
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HILT + exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo HILT + exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline visual analog scale (VAS) at 4th and 12th week.
Description
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).
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks.
Description
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.
Time Frame
Up to12 weeks
Title
Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th weeks
Description
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).
Time Frame
Up to12 weeks
Title
Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks.
Description
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.
Time Frame
up to 12 weeks
Title
Change from baseline static and dynamic pedobarographic evaluations at 4th and 12th weeks.
Description
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.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hilal Yesil
City
Afyon
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
0300
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
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