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

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• Heel Spur 26

Keywords

• HILT
• calcaneal spur
• placebo

Heel Spur

26 studies on the registry are indexed under Heel Spur; 8 are open to participants now.

This study's enrollment of 42 is below the median of 55 across 20 interventional studies indexed under Heel Spur.

Lead sponsor

Hilal Yeşil is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study arms

• 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

• 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

Interventions

• OtherHILT + 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.

• OtherPlacebo 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 outcomes

1. 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).

   Time frame: up to 12 weeks

Secondary outcomes

1. 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.

   Time frame: Up to12 weeks

2. 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).

   Time frame: Up to12 weeks

3. 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.

   Time frame: up to 12 weeks

4. 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.

   Time frame: up to 12 weeks