Sports Physical TherapyNCT05736809
Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping in Football Players
A study testing Low-dye taping and Plantar fascia stretching in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Low-dye taping and Plantar fascia stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Dec 2022to Feb 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female football players
- Age (20-45 yrs)
- Pain with the first step upon walking
- Pain located at the heel or Planter surface of Mid-foot consistent with Planter fasciitis
- Presence of an everted calcaneus greater than or equal to 2°
Who cannot join
- Patient with surgery and treatment with previous 6 month
- History of Ankle or foot fracture
- Congenital deformity of the foot and ankle
- Sever Spasticity
- Use of an Assistive device
- Bilateral Planter heel pain
- Refusal to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping on Acute Plantar Heal Pain and Functional Activity Level in Football Players
Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players.
Read the detailed description
Planter fascia is a fibrous connective tissue originate from the medial calcaneal tubercle and help support the arch of the foot repetitive tensile overload from standing for long periods of time or running causes changes in the aponeurosis. Patient mostly present with pain on first step in the morning or after long non-weight bearing , Tenderness to anterior medial head. Its can first be treated conservatively where 90 % cases treated greater then 6 months of duration. Baseline treatment is given as Rest , Ice , compression and Elevation , with this NSAID ,shoe inset ,Taping, orthotics, deep friction massage and precautions are advised to the patients. Arch taping is most probably used and orthotics in acute treatment is commonly preferred due to its cost.Taping effects most probably overlooked in general gait parameters, patient feedback on pain relief and function recovery.
- Conditions
- Sports Physical Therapy
- Being tested
- Low-dye taping, Plantar fascia stretching, sham taping
- Keywords
- Calcaneal Taping, ,, Plantar Fascia,, Low Dye Taping, Foot,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dye tapingOther
Low-dye taing using 4 tapes around calcaneam
Plantar fascia stretchingOther
out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage
sham tapingOther
out of 21 participants 7 will be included in the study design as an plecebo group using sham taping in acute stage
| Study group | Role | What they receive |
|---|---|---|
| Low-Dye taping | Experimental | out of 21 participants 7 will be included in the study design as an experimental group using low-dye taping in acute stage Receives: Other: Low-dye taping |
| Plantar fascia stretching | Active comparator | out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage Receives: Other: Plantar fascia stretching |
| Sham taping | Placebo comparator | out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage Receives: Other: sham taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric pain rating scale
The Numeric Pain Rating Scale (NPRS) is a famous strategy to evaluate Pain. The NPRS has a dependable, substantial and delicate instrument to survey torment. Torment score as per the NPRS (0-10), made during the principal strides toward the beginning of the day, was the essential result (0 as "no aggravation" and 10 as "exceptionally serious agony").
Measured: 3 week
foot and ankle disability index
It is utilized to evaluate the utilitarian restrictions connected with foot and lower leg, action of day to day living and most troublesome errand that are vital for sports e.g., Walk, word related execution, Agony, Rest and Strength. The foot and ankle disability index (FADI) is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability. The total FADI score corresponds to the sum of Activity and Pain subscale scores (maximum score of 88 for Activity and 16 for Pain).
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start19 Dec 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Crossover
- Model description
- The study would be a RCT (Randomized control trial) at Pakistan sports board in which convenience sampling technique would be used .This study include total 21 participants and for this purpose lotare method would be used to select the participants on comparison of calcaneal taping , planter fascia stretching and sham taping for one week for acute treatment . Each groups contain 7 participants with heel pain with baseline treatment will be given to each of the groups .
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Dr Tariq, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736809
- Sponsor's protocol ID
- 30162
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2023
- Last updated
- 21 Feb 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping on Acute Plantar Heal Pain and Functional Activity Level in Football Players
- ClinicalTrials.gov ID
- NCT05736809
- Acronym / sponsor ID
- 30162
- Conditions
- Sports Physical Therapy
- Keywords
- Calcaneal Taping, ,, Plantar Fascia,, Low Dye Taping, Foot,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Feb 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.
Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players.
Detailed description
Planter fascia is a fibrous connective tissue originate from the medial calcaneal tubercle and help support the arch of the foot repetitive tensile overload from standing for long periods of time or running causes changes in the aponeurosis. Patient mostly present with pain on first step in the morning or after long non-weight bearing , Tenderness to anterior medial head. Its can first be treated conservatively where 90 % cases treated greater then 6 months of duration. Baseline treatment is given as Rest , Ice , compression and Elevation , with this NSAID ,shoe inset ,Taping, orthotics, deep friction massage and precautions are advised to the patients. Arch taping is most probably used and orthotics in acute treatment is commonly preferred due to its cost.Taping effects most probably overlooked in general gait parameters, patient feedback on pain relief and function recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study would be a RCT (Randomized control trial) at Pakistan sports board in which convenience sampling technique would be used .This study include total 21 participants and for this purpose lotare method would be used to select the participants on comparison of calcaneal taping , planter fascia stretching and sham taping for one week for acute treatment . Each groups contain 7 participants with heel pain with baseline treatment will be given to each of the groups .
| Arm | Type | Receives |
|---|---|---|
| Low-Dye taping | Experimental | Other: Low-dye tapingout of 21 participants 7 will be included in the study design as an experimental group using low-dye taping in acute stage |
| Plantar fascia stretching | Active comparator | Other: Plantar fascia stretchingout of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage |
| Sham taping | Placebo comparator | Other: sham tapingout of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female football players
- Age (20-45 yrs)
- Pain with the first step upon walking
- Pain located at the heel or Planter surface of Mid-foot consistent with Planter fasciitis
- Presence of an everted calcaneus greater than or equal to 2°
Key exclusion criteria (7 listed)
- Patient with surgery and treatment with previous 6 month
- History of Ankle or foot fracture
- Congenital deformity of the foot and ankle
- Sever Spasticity
- Use of an Assistive device
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 |
|---|---|---|
| Low-dye tapingLow-dye taing using 4 tapes around calcaneam | Other | Low-Dye taping |
| Plantar fascia stretchingout of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage | Other | Plantar fascia stretching |
| sham tapingout of 21 participants 7 will be included in the study design as an plecebo group using sham taping in acute stage | Other | Sham taping |
Primary outcome
numeric pain rating scale
Time frame: 3 week
The Numeric Pain Rating Scale (NPRS) is a famous strategy to evaluate Pain. The NPRS has a dependable, substantial and delicate instrument to survey torment. Torment score as per the NPRS (0-10), made during the principal strides toward the beginning of the day, was the essential result (0 as "no aggravation" and 10 as "exceptionally serious agony").
foot and ankle disability index
Time frame: 3 week
It is utilized to evaluate the utilitarian restrictions connected with foot and lower leg, action of day to day living and most troublesome errand that are vital for sports e.g., Walk, word related execution, Agony, Rest and Strength. The foot and ankle disability index (FADI) is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability. The total FADI score corresponds to the sum of Activity and Pain subscale scores (maximum score of 88 for Activity and 16 for Pain).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Fatima Dr Tariq, Phd principal investigator
Riphah International 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 Low-dye taping and Plantar fascia stretching in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
numeric pain rating scale (time frame: 3 week). The study lists 2 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 2023.