Plantar FascitisNCT03873961
Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis
A study testing High-intensity laser therapy and Low-level Laser therapy in people with Plantar Fascitis and Achilles Tendon Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Plantar Fascitis, Achilles Tendon Pain
- What is being tested?
- High-intensity laser therapy and Low-level Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteLithuania
- Study dates
- 3 Jan 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral painful activity related symptoms from the Achilles region
- tenderness during palpation of Achilles insertion on calcaneus or couple centimeters above
- unilateral plantar heel pain, mainly during the first few steps upon rising in the morning
- tenderness at the insertion site of the plantar fascia o the calcaneus
Who cannot join
- bilateral heel pain
- other acute pathology (febrile fever, cold. etc.) that require treatment
- other painful conditions that require painkillers (tooth pain, back pain, etc)
- pregnancy
- history of recent trauma or foot surgery
- wounds, infections in treatment area
Show all 12Show fewer
- impaired sensation in treatment area
- pigmentation changes on the skin in treatment area (tattoo, birthmarks)
- received oral or injected corticosteroids within the last 26 weeks
- diagnosis of systemic inflammatory arthritis (goat, rheumatoid arthritis, etc)
- diagnosis of neurological heel pain (radiculopathy)
- diagnosis of other heel pathology (calcaneal stress fracture, osteomyelitis, plantar fascia neoplasm, plantar fascia rupture, etc)
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
The Lithuanian University of Health Sciences, Department of Rehabilitation
Kaunas, LT 44307
About this study
Official title: Short and Long Term Effect of High Intensity Versus Low-Level Laser Therapy in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis: A Single Blinded Randomized Controlled Clinical Trial.
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy
Read the detailed description
Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole of the foot under the heel, which sometimes extends into the medial arch. Pain associated with the condition may cause substantial disability and poor health-related quality of life. Achilles tendinitis is a common etiology of posterior heel pain that results in significant pain and loss of function. Calf exercise is initial management that may be supported by laser therapy. A treatment possibility high-intensity laser therapy is little explored. High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but high-intensity laser therapy is more effective.
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos.
- Conditions
- Plantar Fascitis, Achilles Tendon Pain
- Being tested
- High-intensity laser therapy, Low-level Laser therapy
- Keywords
- High-Intensity Laser Therapy, Low-level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapyDevice
Also called BTL-6000 High Intensity Laser 12 W with 10 mm pen
tissue photobiostimulation for pain reduction and healing enhancement.
Low-level Laser therapyDevice
Also called LAS-Expert with laser shower
tissue photobiostimulation for pain reduction and healing enhancement.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy | Experimental | The participants received stretching and exercise guidance and underwent the BTL-6000 High Intensity Laser 12 W with 10 mm pen applicator high intensity laser procedures (mode = continuous, power = 7 W, dose = 120 J/cm2, total time= 7 min. 8 sec.) 3 times per week (total of 8 procedures). Receives: Device: High-intensity laser therapy |
| Low-level laser therapy | Active comparator | The participants received stretching and exercise guidance underwent the LAS-Expert with laser shower applicator Low-level Laser therapy procedures (785 nm wavelength, 4,0 J/cm2, 35cm2, 6:40 min) 3 times per week (total of 8 procedures). Receives: Device: Low-level Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Measured: Baseline
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Measured: After 3 weeks of treatment
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Measured: 4 weeks follow up
Secondary outcomes (7)
Pain - pressure algometry
Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)
Measured: Baseline to 3 weeks and 4 weeks follow up
Range of motion - goniometry
Ankle and first toe dorsiflexion and plantarflexion was measured in both affected and healthy feet. It was measured in standardized position with goniometer (degrees)
Measured: Baseline to 3 weeks and 4 weeks follow up
Tendon thickness measurement - ultrasound
Thickness of tendon was measured with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm).
Measured: Baseline to 3 weeks and 4 weeks follow up
Functional health and well-being - SF-36v2®
Paper questionnaire for participants to fill in. Medical Outcomes Study Short Form 36 2 version (SF-36v2) was used. Measure is divided into 8 subscales and 2 composite domains The 8 subscales are Physical Functioning, Role Limitations due to Physical Problems, General Health Perceptions, Vitality, Social Functioning, Role Limitations due to Emotional Problems, General Mental Health and Health Transition. Respondents were asked to answer items referring to the past 4 weeks Recommended scoring system for the SF-36 is a weighted Likert system for each item Items within subscales are totaled to provide a summed score for each subscale or dimension.
Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Measured: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form
Paper questionnaire for participants to fill in. The questionnaire consists of 34 questions grouped into 5 subcategories: pain, stiffness, difficulty, activity limitation, and social issues. The answers are represented by a 4-level Likert scale. The numerical 5 is not a Likert scale; it is an option that the particular question is not applicable. A higher score represents worse condition.
Measured: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure
Paper questionnaire for participants to fill in. Foot and Ankle Ability Measure consists of the 21-item activities of daily living and 8-item Sports subscales. The response to each item is scored by Likert scale from 4 to 0, with 4 being "no difficulty" and 0 being "unable to do". A higher score represents a higher level of physical function.
Measured: Baseline to 3 weeks and 4 weeks follow up
Pain - numerical pain rating scale
Numerical pain rating scale from 0 to 10 ("0" = no pain, "10" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Measured: Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start3 Jan 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania
- Responsible party
- Principal investigator, Dovile Naruseviciute, Lithuanian University of Health Sciences
- Investigators
- Raimondas Kubilius, professor, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873961
- Sponsor's protocol ID
- 2016-07-14 Nr.BE-2-32
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Effect of High Intensity Versus Low-Level Laser Therapy in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis: A Single Blinded Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03873961
- Acronym / sponsor ID
- 2016-07-14 Nr.BE-2-32
- Conditions
- Plantar Fascitis, Achilles Tendon Pain
- Keywords
- High-Intensity Laser Therapy, Low-level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Research Council of Lithuania
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy
Detailed description
Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole of the foot under the heel, which sometimes extends into the medial arch. Pain associated with the condition may cause substantial disability and poor health-related quality of life. Achilles tendinitis is a common etiology of posterior heel pain that results in significant pain and loss of function. Calf exercise is initial management that may be supported by laser therapy. A treatment possibility high-intensity laser therapy is little explored. High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but high-intensity laser therapy is more effective.
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy | Experimental | Device: High-intensity laser therapyThe participants received stretching and exercise guidance and underwent the BTL-6000 High Intensity Laser 12 W with 10 mm pen applicator high intensity laser procedures (mode = continuous, power = 7 W, dose = 120 J/cm2, total time= 7 min. 8 sec.) 3 times per week (total of 8 procedures). |
| Low-level laser therapy | Active comparator | Device: Low-level Laser therapyThe participants received stretching and exercise guidance underwent the LAS-Expert with laser shower applicator Low-level Laser therapy procedures (785 nm wavelength, 4,0 J/cm2, 35cm2, 6:40 min) 3 times per week (total of 8 procedures). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral painful activity related symptoms from the Achilles region
- tenderness during palpation of Achilles insertion on calcaneus or couple centimeters above
- unilateral plantar heel pain, mainly during the first few steps upon rising in the morning
- tenderness at the insertion site of the plantar fascia o the calcaneus
Key exclusion criteria (12 listed)
- bilateral heel pain
- other acute pathology (febrile fever, cold. etc.) that require treatment
- other painful conditions that require painkillers (tooth pain, back pain, etc)
- pregnancy
- history of recent trauma or foot surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity laser therapyAlso: BTL-6000 High Intensity Laser 12 W with 10 mm pentissue photobiostimulation for pain reduction and healing enhancement. | Device | High-intensity laser therapy |
| Low-level Laser therapyAlso: LAS-Expert with laser showertissue photobiostimulation for pain reduction and healing enhancement. | Device | Low-level laser therapy |
Primary outcome
Pain - visual analog scale
Time frame: Baseline
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Pain - visual analog scale
Time frame: After 3 weeks of treatment
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Pain - visual analog scale
Time frame: 4 weeks follow up
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
7 secondary outcomes
Pain - pressure algometry
Time frame: Baseline to 3 weeks and 4 weeks follow up
Range of motion - goniometry
Time frame: Baseline to 3 weeks and 4 weeks follow up
Tendon thickness measurement - ultrasound
Time frame: Baseline to 3 weeks and 4 weeks follow up
Functional health and well-being - SF-36v2®
Time frame: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form
Time frame: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure
Time frame: Baseline to 3 weeks and 4 weeks follow up
Pain - numerical pain rating scale
Time frame: Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Plantar Fascitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raimondas Kubilius, professor principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser therapy and Low-level Laser therapy in people with Plantar Fascitis and Achilles Tendon Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - visual analog scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.