Plantar FascitisNCT05867888
Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
A study testing conventional therapy, shock wave therapy and low level laser therapy in people with Plantar Fascitis, run by Cairo University at 1 site in Egypt.
Trial summary
Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- conventional therapy, shock wave therapy and low level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 10 Oct 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges from 40-60 years old.
- Both genders will be included.
- Unilateral plantar fasciitis.
- Duration of symptoms more than 4 weeks.
- Positive Windlass test and negative Tinel and calcaneus squeeze tests.
- Patients will be classified according to their BMI (18.5 - 24.9) kg/m2
Who cannot join
- Open wound, infection in plantar surface of foot.
- History of foot surgery.
- History of trauma or fracture in foot or ankle.
- Neuropathic pain as diabetes mellitus.
- Peripheral vascular disease.
- Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel.
- Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.
Read the detailed description
Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition.
Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.
- Conditions
- Plantar Fascitis
- Being tested
- conventional therapy, shock wave therapy, low level laser therapy
- Keywords
- low level laser therapy, shock wave therapy, stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises )
shock wave therapyOther
Acoustic waves (shock waves) that can carry energy and can propagate through tissues promote healing effects.
low level laser therapyOther
The application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises). Receives: Other: conventional therapy |
| Experimental group 1 | Experimental | Shock wave therapy + Conventional physical therapy. Receives: Other: conventional therapy; Other: shock wave therapy |
| Experimental group 2 | Experimental | Low level laser therapy + Conventional physical therapy. Receives: Other: conventional therapy; Other: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change in pain intensity level
The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.
Measured: Before treatment and after 6 weeks treatment
Assess the change in pain pressure threshold
Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.
Measured: Before treatment and after 6 weeks treatment
Assess the change in range of ankle motion
Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.
Measured: Before treatment and after 6 weeks treatment
Assess the change in foot functional disability
Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.
Measured: Before treatment and after 6 weeks treatment
Assess the change in ankle stability
The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.
Measured: Before treatment and after 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohamed Lotfy Soliman, Cairo University
- Investigators
- Fatma S Amin, Professor, Study chair, Cairo UniversityRania N Karkousha, Ass.prof, Study director, Cairo UniversityMohamed I Abd Elhay, Lecturer, Study director, Cairo UniversityAshraf N Moharram, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867888
- Sponsor's protocol ID
- P.T.REC/012/004154
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05867888
- Acronym / sponsor ID
- P.T.REC/012/004154
- Conditions
- Plantar Fascitis
- Keywords
- low level laser therapy, shock wave therapy, stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 22 May 2023 (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.
Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.
Detailed description
Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition.
Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: conventional therapyconventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises). |
| Experimental group 1 | Experimental | Other: conventional therapy, Other: shock wave therapyShock wave therapy + Conventional physical therapy. |
| Experimental group 2 | Experimental | Other: conventional therapy, Other: low level laser therapyLow level laser therapy + Conventional physical therapy. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ranges from 40-60 years old.
- Both genders will be included.
- Unilateral plantar fasciitis.
- Duration of symptoms more than 4 weeks.
- Positive Windlass test and negative Tinel and calcaneus squeeze tests.
Key exclusion criteria (7 listed)
- Open wound, infection in plantar surface of foot.
- History of foot surgery.
- History of trauma or fracture in foot or ankle.
- Neuropathic pain as diabetes mellitus.
- Peripheral vascular disease.
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 |
|---|---|---|
| conventional therapyconventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises ) | Other | Control group, Experimental group 1, Experimental group 2 |
| shock wave therapyAcoustic waves (shock waves) that can carry energy and can propagate through tissues promote healing effects. | Other | Experimental group 1 |
| low level laser therapyThe application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain. | Other | Experimental group 2 |
Primary outcome
Assess the change in pain intensity level
Time frame: Before treatment and after 6 weeks treatment
The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.
Assess the change in pain pressure threshold
Time frame: Before treatment and after 6 weeks treatment
Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.
Assess the change in range of ankle motion
Time frame: Before treatment and after 6 weeks treatment
Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.
Assess the change in foot functional disability
Time frame: Before treatment and after 6 weeks treatment
Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.
Assess the change in ankle stability
Time frame: Before treatment and after 6 weeks treatment
The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.
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 21 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
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.
Fatma S Amin, Professor study chair
Cairo University
Rania N Karkousha, Ass.prof study director
Cairo University
Mohamed I Abd Elhay, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy, shock wave therapy and low level laser therapy in people with Plantar Fascitis, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 7 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 21 Feb 2024. 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 Egypt. 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?
Assess the change in pain intensity level (time frame: Before treatment and after 6 weeks treatment). The study lists 5 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 21 Feb 2024.