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

NCT ID: NCT03907085

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2016-12-01

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.

Conditions

Calcaneal Spur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

HILT + exercise

Intervention Type: OTHER

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 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.

Group Type: PLACEBO_COMPARATOR

Placebo HILT + exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hilal Yeşil

OTHER

Sponsor Role: lead

Responsible Party

Hilal Yeşil

Assist. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HYHILT2019

Identifier Type: -

Identifier Source: org_study_id