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

NCT03907085 | Completed

• 1 other identifier: HYHILT2019
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Calcaneal Spur

Keywords

HILT; calcaneal spur; placebo

Outcome Measures

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).

  up to 12 weeks

Secondary Outcomes (4)

• Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks.

  Up to12 weeks

• Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th weeks

  Up to12 weeks

• Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks.

  up to 12 weeks

• Change from baseline static and dynamic pedobarographic evaluations at 4th and 12th weeks.

  up to 12 weeks

Study Arms (2)

High intensity laser therapy (HILT) + exercise

ACTIVE COMPARATOR

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 HILT + exercise

PLACEBO COMPARATOR

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

HILT + exercise 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.

High intensity laser therapy (HILT) + exercise

Placebo HILT + exercise 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.

Placebo HILT + exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hilal Yeşil: lead

Study Sites (1)

Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, 0300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Exercise

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

TU (1)