Plantar FascitisNCT05856019
Effects of J Stroke Myofascial Release in Patients With Planter Fasciitis
A study testing J Stroke Myofascial Release and Ischemic Release on Gastrocnemius through Dry Cupping in people with Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effects of j stroke myofascial release on planter fascia versus ischemic release on gastrocnemius in patients with planter fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- J Stroke Myofascial Release and Ischemic Release on Gastrocnemius through Dry Cupping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to 1 Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60years
- Both Genders
- Chronic pain
- Heel pain with current and previous diagnosis of planter faucitis
- Unilateral planter fascia involvement
- Mild to moderate heel pain with NPRS pain score value between 2-6
Who cannot join
- Recent surgery to ankle joint
- Impaired sensations
- Open wound
- Peripheral vascular disease
- Recent fractures (<6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of J Stroke Myofascial Release on Plantar Fascia Versus Ischemic Release on Gastrocnemius in Patients With Planter Fasciitis
The purpose of the study is to compare the effects of j stroke myofascial release on planter fascia versus ischemic release on gastrocnemius in patients with planter fasciitis.
Read the detailed description
Planter fasciitis is commonly occur in athletes and females who wear flat shoes. It is caused by the loss of planter fascia flexibility that leads to mechanical overloading of fascial structures. There are some risk factors that are important to consider include age, leg length difference, inadequate footwear, inappropriate walking and running patterns and increased planter fascia thickness. Planter fascia thickness more than 4mm can be considered as an indicative of planter fasciitis.
Myofascial soft tissue mobilization is a low load, long duration stretch to the myofascial complex technique that is given in both acute and chronic conditions which in caused by tightness and soft tissue restriction in the patients with planter fasciitis to restore length, decrease pain and to improve function.
Cupping therapy on gastrocnemius is a medical technique that applies negative pressure over pain areas and pressure points that alleviates pain and improve blood circulation. it could be low-cost and convenient alternative technique to treat planter fasciitis.
- Conditions
- Plantar Fascitis
- Being tested
- J Stroke Myofascial Release, Ischemic Release on Gastrocnemius through Dry Cupping
- Keywords
- planter fascitis, J stroke myofascial release, Ischemic release on gastrocnemius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J Stroke Myofascial ReleaseOther
Group A will receive J stroke myofascial release on planter fascia (with hot pack for 10-15 minutes on calf) 3 sessions per week for 4 weeks.
Ischemic Release on Gastrocnemius through Dry CuppingOther
Group B will ischemic release on gastrocnemius (with hot pack for 10-15 minutes on calf) 3 sessions per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| J Stroke Myofascial Release | Experimental | Patient is in prone lying position with foot supported. Pressure is applied with the heel of the opposite hand, while a stroke in the shape of the letter J is applied in the direction of the restriction, with two or three fingers, which creates some torque at the end. Myofascial Release techniques will be performed for 20 repetitions. Receives: Other: J Stroke Myofascial Release |
| Ischemic Release on Gastrocnemius through Dry Cupping | Active comparator | Dry cupping will provided to the subjects thrice a week for 4 weeks in the dry cupping therapy group, a plastic cupping bell will be used. Cups will applied to the painful site for 10 minutes in each session. A manual hand pump was used to create the vacuum for suction. The intensity of the vacuum will based on subject tolerance. Receives: Other: Ischemic Release on Gastrocnemius through Dry Cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Numeric Rating Scale (NPRS) is most frequently used instruments to measure the intensity of ankle pain with an 11-point numerical pain rating scale (NPRS), where 0 is the absence of pain and 10 represents maximum pain. 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs).
Measured: 1st day, 2nd week, 4th week
Secondary outcomes (2)
FFI
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. The FFI should prove useful for both clinical and research purposes
Measured: 1st day, 2nd week, 4th week
Goniometer
Goniometers are commonly used to determine ROM of the ankle joint. Goniometers are considered valid and reliable clinical tools for assessing range of motion of joints of the extremities
Measured: 1st day, 2nd week, 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 May 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856019
- Sponsor's protocol ID
- REC/RCR & AHS/23/0122
- Status last verified
- Dec 2023
- First submitted
- 4 May 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akter S, Hossain MS, Hossain KMA, Uddin Z, Hossain MA, Alom F, Kabir MF, Walton LM, Raigangar V. Comparison of Structural Diagnosis and Management (SDM) approach and MyoFascial Release (MFR) for improving plantar heel pain, ankle range of motion and disability: A randomized clinical trial. J Man Manip Ther. 2024 Aug;32(4):368-377. doi: 10.1080/10669817.2023.2214020. Epub 2023 May 24.
PubMed 37222021Karagounis P, Tsironi M, Prionas G, Tsiganos G, Baltopoulos P. Treatment of plantar fasciitis in recreational athletes: two different therapeutic protocols. Foot Ankle Spec. 2011 Aug;4(4):226-34. doi: 10.1177/1938640011407320.
PubMed 21868796Malik S, Anand P, Bhati P, Hussain ME. Effects of dry cupping therapy on pain, dynamic balance and functional performance in young female with recreational runners chronic plantar fasciitis. Sports Orthopaedics and Traumatology. 2022;38(2):159-70.
Tamboli U, Patil C. Effect of myofascial release with lower limb strengthening on plantar fasciitis. International Journal of Physical Education, Sports and Health. 2021;8(1):27-31.
Vijayakumar M, Jaideep A, Khankal R, Gazbare P, Abraham B. Effectiveness of compressive myofascial release vs instrument assisted soft tissue mobilization in subjects with active trigger points of the calf muscle limiting ankle dorsiflexion. Int J Health Sci Res. 2019;9(4):98-106.
Farooq N, Aslam S, Bashir N, Awan WA, Shah M, Irshad A. Effectiveness of transverse friction massage of Flexor digitorum brevis and Calf muscle stretching in Plantar fasciitis on foot function index scale: A randomized control trial. Isra Med J. 2019;1(4):305-9.
Prakash S, Misra A. Effect of manual therapy versus conventional therapy in patients with plantar fasciitis-a comparative study. Int J Physiother Res. 2014;2(1):378-82.
Armagan Alpturker K, Cerrahoglu ABL, Orguc IS. Evaluation Effects of Laser Therapy and Extracorporeal Shock Wave Therapy with Clinical Parameters and Magnetic Resonance Imaging for Treatment of Plantar Fasciitis in Patients with Spondyloarthritis: A Randomized Controlled Trial. Int J Rheumatol. 2020 Aug 27;2020:4386361. doi: 10.1155/2020/4386361. eCollection 2020.
PubMed 32908536
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
- Effects of J Stroke Myofascial Release on Plantar Fascia Versus Ischemic Release on Gastrocnemius in Patients With Planter Fasciitis
- ClinicalTrials.gov ID
- NCT05856019
- Acronym / sponsor ID
- REC/RCR & AHS/23/0122
- Conditions
- Plantar Fascitis
- Keywords
- planter fascitis, J stroke myofascial release, Ischemic release on gastrocnemius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 12 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.
The purpose of the study is to compare the effects of j stroke myofascial release on planter fascia versus ischemic release on gastrocnemius in patients with planter fasciitis.
Detailed description
Planter fasciitis is commonly occur in athletes and females who wear flat shoes. It is caused by the loss of planter fascia flexibility that leads to mechanical overloading of fascial structures. There are some risk factors that are important to consider include age, leg length difference, inadequate footwear, inappropriate walking and running patterns and increased planter fascia thickness. Planter fascia thickness more than 4mm can be considered as an indicative of planter fasciitis.
Myofascial soft tissue mobilization is a low load, long duration stretch to the myofascial complex technique that is given in both acute and chronic conditions which in caused by tightness and soft tissue restriction in the patients with planter fasciitis to restore length, decrease pain and to improve function.
Cupping therapy on gastrocnemius is a medical technique that applies negative pressure over pain areas and pressure points that alleviates pain and improve blood circulation. it could be low-cost and convenient alternative technique to treat planter fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| J Stroke Myofascial Release | Experimental | Other: J Stroke Myofascial ReleasePatient is in prone lying position with foot supported. Pressure is applied with the heel of the opposite hand, while a stroke in the shape of the letter J is applied in the direction of the restriction, with two or three fingers, which creates some torque at the end. Myofascial Release techniques will be performed for 20 repetitions. |
| Ischemic Release on Gastrocnemius through Dry Cupping | Active comparator | Other: Ischemic Release on Gastrocnemius through Dry CuppingDry cupping will provided to the subjects thrice a week for 4 weeks in the dry cupping therapy group, a plastic cupping bell will be used. Cups will applied to the painful site for 10 minutes in each session. A manual hand pump was used to create the vacuum for suction. The intensity of the vacuum will based on subject tolerance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60years
- Both Genders
- Chronic pain
- Heel pain with current and previous diagnosis of planter faucitis
- Unilateral planter fascia involvement
Key exclusion criteria (5 listed)
- Recent surgery to ankle joint
- Impaired sensations
- Open wound
- Peripheral vascular disease
- Recent fractures (<6 months)
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 |
|---|---|---|
| J Stroke Myofascial ReleaseGroup A will receive J stroke myofascial release on planter fascia (with hot pack for 10-15 minutes on calf) 3 sessions per week for 4 weeks. | Other | J Stroke Myofascial Release |
| Ischemic Release on Gastrocnemius through Dry CuppingGroup B will ischemic release on gastrocnemius (with hot pack for 10-15 minutes on calf) 3 sessions per week for 4 weeks. | Other | Ischemic Release on Gastrocnemius through Dry Cupping |
Primary outcome
NPRS
Time frame: 1st day, 2nd week, 4th week
Numeric Rating Scale (NPRS) is most frequently used instruments to measure the intensity of ankle pain with an 11-point numerical pain rating scale (NPRS), where 0 is the absence of pain and 10 represents maximum pain. 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs).
2 secondary outcomes
FFI
Time frame: 1st day, 2nd week, 4th week
Goniometer
Time frame: 1st day, 2nd week, 4th week
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 29 Dec 2023.
- Background: PubMed 37222021Akter S, Hossain MS, Hossain KMA, Uddin Z, Hossain MA, Alom F, Kabir MF, Walton LM, Raigangar V. Comparison of Structural Diagnosis and Management (SDM) approach and MyoFascial Release (MFR) for improving plantar heel pain, ankle range of motion and disability: A randomized clinical trial. J Man Manip Ther. 2024 Aug;32(4):368-377. doi: 10.1080/10669817.2023.2214020. Epub 2023 May 24.
- Background: PubMed 21868796Karagounis P, Tsironi M, Prionas G, Tsiganos G, Baltopoulos P. Treatment of plantar fasciitis in recreational athletes: two different therapeutic protocols. Foot Ankle Spec. 2011 Aug;4(4):226-34. doi: 10.1177/1938640011407320.
- BackgroundMalik S, Anand P, Bhati P, Hussain ME. Effects of dry cupping therapy on pain, dynamic balance and functional performance in young female with recreational runners chronic plantar fasciitis. Sports Orthopaedics and Traumatology. 2022;38(2):159-70.
- BackgroundTamboli U, Patil C. Effect of myofascial release with lower limb strengthening on plantar fasciitis. International Journal of Physical Education, Sports and Health. 2021;8(1):27-31.
- BackgroundVijayakumar M, Jaideep A, Khankal R, Gazbare P, Abraham B. Effectiveness of compressive myofascial release vs instrument assisted soft tissue mobilization in subjects with active trigger points of the calf muscle limiting ankle dorsiflexion. Int J Health Sci Res. 2019;9(4):98-106.
- BackgroundFarooq N, Aslam S, Bashir N, Awan WA, Shah M, Irshad A. Effectiveness of transverse friction massage of Flexor digitorum brevis and Calf muscle stretching in Plantar fasciitis on foot function index scale: A randomized control trial. Isra Med J. 2019;1(4):305-9.
- BackgroundPrakash S, Misra A. Effect of manual therapy versus conventional therapy in patients with plantar fasciitis-a comparative study. Int J Physiother Res. 2014;2(1):378-82.
- Background: PubMed 32908536Armagan Alpturker K, Cerrahoglu ABL, Orguc IS. Evaluation Effects of Laser Therapy and Extracorporeal Shock Wave Therapy with Clinical Parameters and Magnetic Resonance Imaging for Treatment of Plantar Fasciitis in Patients with Spondyloarthritis: A Randomized Controlled Trial. Int J Rheumatol. 2020 Aug 27;2020:4386361. doi: 10.1155/2020/4386361. eCollection 2020.
- 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.
Rabiya Noor, 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 J Stroke Myofascial Release and Ischemic Release on Gastrocnemius through Dry Cupping in people with Plantar Fascitis, 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 6 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: finished, 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?
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?
NPRS (time frame: 1st day, 2nd week, 4th week). 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 NCT05856019, which also lists 8 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.