The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur: a Double Blind, Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change from baseline visual analog scale (VAS) at 4th and 12th week.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: HILT + exercise (Other)
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.
Intervention: Placebo HILT + exercise (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th weeks(Up to12 weeks)
- Change from baseline quality of life (short form 36 (SF-36)) 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)
Investigators
Hilal Yeşil
Assist. Prof.
Ege University