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The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur

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ClinicalTrials.gov Identifier: NCT03907085
Recruitment Status : Completed
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hilal Yeşil, Ege University

Brief Summary:
The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study

Condition or disease Intervention/treatment Phase
Calcaneal Spur Other: HILT + exercise Other: Placebo HILT + exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur: a Double Blind, Placebo-controlled Study
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


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.
Other: HILT + exercise
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.

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.
Other: Placebo HILT + exercise
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 Measures :
  1. Change from baseline visual analog scale (VAS) at 4th and 12th week. [ Time Frame: up to 12 weeks ]
    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 :
  1. 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.

  2. 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).

  3. Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks. [ Time Frame: up to 12 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.

  4. 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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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907085


Locations
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Turkey
Hilal Yesil
Afyon, Eyalet/Yerleşke, Turkey, 0300
Sponsors and Collaborators
Hilal Yeşil

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Responsible Party: Hilal Yeşil, Assist. Prof., Ege University
ClinicalTrials.gov Identifier: NCT03907085     History of Changes
Other Study ID Numbers: HYHILT2019
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hilal Yeşil, Ege University:
HILT
calcaneal spur
placebo
Additional relevant MeSH terms:
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Heel Spur
Exostoses
Hyperostosis
Bone Diseases
Musculoskeletal Diseases
Foot Diseases