GaitNCT06131762
Effects of Active and PRT on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fascitis
A study testing Active release technique and Positional release technique in people with Gait and Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gait, Pain, Plantar Fascitis
- What is being tested?
- Active release technique and Positional release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2023to 20 Feb 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male runners age between 18-30 years
- Duration of running at least 6 months
- Positive windlass test
- Patients with unilateral or bilateral plantar fasciitis
Who cannot join
- Recent accidental foot or ankle injury
- Previous lower-body surgical intervention within 6 months
- Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months
- Diagnosed musculoskeletal disorders (rheumatoid arthritis, calcaneal spurs)
- Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jawad club, Alfatah sports complex
Faisalābad, Punjab Province, 38000
Hamza Azeem, BBA, 03247664872, hamza.azeem2018@gmail.com
Athar Azeem, Dpt, 03350079772, atharazzem420@gmail.com
About this study
Official title: Comparative Effects of Active and Positional Release Technique on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fasciitis
The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks
Read the detailed description
A single blinded randomized clinical trial will be conducted on 26 subjects diagnosed for planter fasciitis from Jawad Club Faisalabad and Alfatah Sports Club, Faisalabad by looking for symptoms and tenderness at heel as mentioned in inclusion criteria and will confirmed by windlass test. Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks. Pain will be measured by Numerical Pain Rating Scale (NPRS), Foot and ankle disability will be assessed by Foot Function Index (FFI), while gait parameters i.e. walking speed will be measured by 4-meter walking test, and step and stride length will be evaluated by measuring tape by taking foot prints before and after the 4 weeks of treatment period. Data will be analyzed through statistical package for the social sciences (SPSS) version 22.
- Conditions
- Gait, Pain, Plantar Fascitis
- Being tested
- Active release technique, Positional release technique
- Keywords
- pain, functions
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active release techniqueOther
This include active release technique for 4 weeks
Positional release techniqueOther
This include positional release technique for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active release technique | Experimental | ART performed from long sitting position, the therapist started by shortening the muscle or fascia of affected limb then apply very specific pressure with hand as we stretch tissue is lengthened. Active movement is done whenever possible according to the instructions given by therapist. ART for 8-10 minutes will be given. Receives: Other: Active release technique |
| Positional release technique | Experimental | Positional release technique where participant lie supine with the affected limb out of the plinth and then by application of brief mechanical pressure on tender point with one fingertip in order to determine tenderness. The foot should then be positioned, most probably into pure plantarflexion and gentle fine-tuned by rotation, until the score in the tender point has reduce by at least 70%. This position is held for 90 seconds with 3 repetitions i.e. total of 270 seconds was given. Receives: Other: Positional release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters
gait parameters will be measured by 4-meter walking test
Measured: pre and 4 weeks post intervention
Foot Function
Foot function will be assessed by Foot Function Index (FFI),
Measured: pre and 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Feb 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GaitStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trail
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athar Azeem, Dpt, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131762
- Sponsor's protocol ID
- REC/RCR & AHS/23/0432
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brachman A, Sobota G, Marszalek W, Pawlowski M, Juras G, Bacik B. Plantar pressure distribution and spatiotemporal gait parameters after the radial shock wave therapy in patients with chronic plantar fasciitis. J Biomech. 2020 May 22;105:109773. doi: 10.1016/j.jbiomech.2020.109773. Epub 2020 Apr 3.
PubMed 32279933Waclawski ER, Beach J, Milne A, Yacyshyn E, Dryden DM. Systematic review: plantar fasciitis and prolonged weight bearing. Occup Med (Lond). 2015 Mar;65(2):97-106. doi: 10.1093/occmed/kqu177. Epub 2015 Feb 17.
PubMed 25694489Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010 May;39(5):227-31.
PubMed 20567740Thong-On S, Bovonsunthonchai S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Effects of Strengthening and Stretching Exercises on the Temporospatial Gait Parameters in Patients With Plantar Fasciitis: A Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):662-676. doi: 10.5535/arm.2019.43.6.662. Epub 2019 Dec 31.
PubMed 31918529Fabrikant JM, Park TS. Plantar fasciitis (fasciosis) treatment outcome study: plantar fascia thickness measured by ultrasound and correlated with patient self-reported improvement. Foot (Edinb). 2011 Jun;21(2):79-83. doi: 10.1016/j.foot.2011.01.015. Epub 2011 Mar 12.
PubMed 21398108
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Active and Positional Release Technique on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06131762
- Acronym / sponsor ID
- REC/RCR & AHS/23/0432
- Conditions
- Gait, Pain, Plantar Fascitis
- Keywords
- pain, functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 14 Nov 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.
The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks
Detailed description
A single blinded randomized clinical trial will be conducted on 26 subjects diagnosed for planter fasciitis from Jawad Club Faisalabad and Alfatah Sports Club, Faisalabad by looking for symptoms and tenderness at heel as mentioned in inclusion criteria and will confirmed by windlass test. Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks. Pain will be measured by Numerical Pain Rating Scale (NPRS), Foot and ankle disability will be assessed by Foot Function Index (FFI), while gait parameters i.e. walking speed will be measured by 4-meter walking test, and step and stride length will be evaluated by measuring tape by taking foot prints before and after the 4 weeks of treatment period. Data will be analyzed through statistical package for the social sciences (SPSS) version 22.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trail
| Arm | Type | Receives |
|---|---|---|
| Active release technique | Experimental | Other: Active release techniqueART performed from long sitting position, the therapist started by shortening the muscle or fascia of affected limb then apply very specific pressure with hand as we stretch tissue is lengthened. Active movement is done whenever possible according to the instructions given by therapist. ART for 8-10 minutes will be given. |
| Positional release technique | Experimental | Other: Positional release techniquePositional release technique where participant lie supine with the affected limb out of the plinth and then by application of brief mechanical pressure on tender point with one fingertip in order to determine tenderness. The foot should then be positioned, most probably into pure plantarflexion and gentle fine-tuned by rotation, until the score in the tender point has reduce by at least 70%. This position is held for 90 seconds with 3 repetitions i.e. total of 270 seconds was given. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male runners age between 18-30 years
- Duration of running at least 6 months
- Positive windlass test
- Patients with unilateral or bilateral plantar fasciitis
Key exclusion criteria (5 listed)
- Recent accidental foot or ankle injury
- Previous lower-body surgical intervention within 6 months
- Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months
- Diagnosed musculoskeletal disorders (rheumatoid arthritis, calcaneal spurs)
- Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial
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 |
|---|---|---|
| Active release techniqueThis include active release technique for 4 weeks | Other | Active release technique |
| Positional release techniqueThis include positional release technique for 4 weeks | Other | Positional release technique |
Primary outcome
Gait parameters
Time frame: pre and 4 weeks post intervention
gait parameters will be measured by 4-meter walking test
Foot Function
Time frame: pre and 4 weeks post intervention
Foot function will be assessed by Foot Function Index (FFI),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 32279933Brachman A, Sobota G, Marszalek W, Pawlowski M, Juras G, Bacik B. Plantar pressure distribution and spatiotemporal gait parameters after the radial shock wave therapy in patients with chronic plantar fasciitis. J Biomech. 2020 May 22;105:109773. doi: 10.1016/j.jbiomech.2020.109773. Epub 2020 Apr 3.
- Background: PubMed 25694489Waclawski ER, Beach J, Milne A, Yacyshyn E, Dryden DM. Systematic review: plantar fasciitis and prolonged weight bearing. Occup Med (Lond). 2015 Mar;65(2):97-106. doi: 10.1093/occmed/kqu177. Epub 2015 Feb 17.
- Background: PubMed 20567740Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010 May;39(5):227-31.
- Background: PubMed 31918529Thong-On S, Bovonsunthonchai S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Effects of Strengthening and Stretching Exercises on the Temporospatial Gait Parameters in Patients With Plantar Fasciitis: A Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):662-676. doi: 10.5535/arm.2019.43.6.662. Epub 2019 Dec 31.
- Background: PubMed 21398108Fabrikant JM, Park TS. Plantar fasciitis (fasciosis) treatment outcome study: plantar fascia thickness measured by ultrasound and correlated with patient self-reported improvement. Foot (Edinb). 2011 Jun;21(2):79-83. doi: 10.1016/j.foot.2011.01.015. Epub 2011 Mar 12.
- 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.
Athar Azeem, Dpt principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active release technique and Positional release technique in people with Gait and Pain, 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 4 inclusion and 5 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 29 Dec 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. 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?
Contact Malia younas, Ms DPT (03258292286, maliayounas62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters (time frame: pre and 4 weeks post intervention). 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?
On the ClinicalTrials.gov record for NCT06131762, which also lists 5 linked publications.
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 29 Dec 2023.