Plantar FascitisNCT06536803
Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching With Planter Fasciitis
A study testing high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks and high-load strength training with routine physiotherapy in people with Plantar Fascitis and Resistance Training, run by Riphah International University at 1 site in Pakistan.
Trial summary
The rationale behind examining the synergistic impacts of high load strength training and tissues pecific plantar fascia stretching activities in athletes diagnosed with plantar fasciitis arises from an acknowledged deficiency in the existing body of scholarly research.Study design will be Randomized Control Trial. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis, Resistance Training, Muscle Stretching Exercises
- What is being tested?
- high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks and high-load strength training with routine physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2024to 26 Sep 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only Male Athletes
- Prediagnosed Patients suffering from Plantar fasciitis referred from Orthopedic.
- History of inferior heel pain atleast 2 weeks before enrollement.
- Pain on palpation of Medial calcaneal Tubercle/proximal Plantar Fascia.
- All participants with in the age group between 20-35 yrs.
- Patients who are willing to particiapate in the study.
- Heel pain syndrome
Who cannot join
- History of any systemic disease
- Heel and skin infection
- History of prior Surgery
- Corticosteroid injection for Plantar fasciitis within previous 06 momths;
- Any known malignancy /neoplasma involved side.
- Diagnosed/known psychiatric illness
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Youth foot ball club,MOTH
Mirpur Mathelo
Ajmal Mehmood, +923095755273
Muhammad Ilyas, DPT
About this study
Official title: Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching Exercise on Pain Range of Motion and Functional Disability Among the Athletes With Planter Fasciitis
The rationale behind examining the synergistic impacts of high load strength training and tissues pecific plantar fascia stretching activities in athletes diagnosed with plantar fasciitis arises from an acknowledged deficiency in the existing body of scholarly research.Study design will be Randomized Control Trial. The study will be completed in 10 months after Synopsis Approval.The study will be carried in sports clubs of MOTH Mirpur AJK. Convenient Sampling will be used. Data Collection Tools will be used named as VAS, Functional foot index (FFI), and Goniometry used for Pain, functional disability and range of motion will be measured respectively before and after the intervention
Read the detailed description
Population is divided into 2 groups: Group A and Group B. Both groups will be given a patient evaluation sheet and thickness of planter fascia will be already measured by Ultrasound. Group A will then receive high load strength training and routine physiotherapy. Group B will receive high load strength training and Tissue-specific plantar fascia stretching exercise and routine physiotherapy. Pain, range of motion and functional disability will be measured before session, immediate effect after first session, then after 06 weeks (18 session) with high load strength training maximum repetition 12 RM with 3 sets in alternative days in each set minimum 2 mint rest interval and tissue specific plantar fascia stretching exercise perform for 10 times for 10 sec, after 12 weeks (36 sessions) with high load strength training maximum repetition 10 RM with 4 sets in alternative days in each set minimum 2 mint rest interval tissue specific plantar fascia stretching exercise perform for 10 times for 10 sedate will be entered and analyzed by SPSS version 21. Statistical significance will be p=0.05 Descriptive statistics: Frequency tables, pie charts, bar charts will be used.
- Being tested
- high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks, high-load strength training with routine physiotherapy
- Keywords
- plantar heel pain,High-load strength training,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeksOther
high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks
high-load strength training with routine physiotherapyOther
high load strength training with routine physiotherapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| high-load strength training with tisssue specific plantar fascia stretching exercise | Active comparator | Experimental group will receive high load strength training and Tissue-specific plantar fascia stretching exercise and routine physiotherapy. Pain, range of motion and functional disability will be measured before session, immediate effect after first session,then after 06 weeks (18 session) with high load strength training maximum repetition 12 RM with 3 sets in alternative days in each set minimum 2 mint rest interval and tissue specific plantar fascia stretching exercise perform for 10 times for 10 sec, after 12 weeks (36 sessions) with high load strength training maximum repetition 10 RM with 4 sets in alternative days in each set minimum 2 mint rest interval tissue specific plantar fascia stretching exercise perform for 10times Receives: Other: high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks |
| high-load strength training with routine physiotherapy | Active comparator | active compator group will then receive high load strength training and routine physiotherapy ultrasonic therapy Receives: Other: high-load strength training with routine physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
will be measured through goniometer
Measured: 0 week,6 weeks ,12 week
functional disability measured through Foot Function Index
will be measured through Foot Function Index
Measured: 0 week,6 weeks ,12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start26 Jun 2024
- Primary completion26 Sep 2024 (estimated)
- Study completion26 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad ilyas, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536803
- Sponsor's protocol ID
- REC/RCR&AHS/23/0471
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
PubMed 21916393Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
PubMed 25145882Huffer D, Hing W, Newton R, Clair M. Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. Phys Ther Sport. 2017 Mar;24:44-52. doi: 10.1016/j.ptsp.2016.08.008. Epub 2016 Aug 18.
PubMed 27692740Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.
PubMed 16882901Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg. 2015 Dec;24(Pt B):135-42. doi: 10.1016/j.ijsu.2015.04.082. Epub 2015 May 1.
PubMed 25940060Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
PubMed 18524985
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching Exercise on Pain Range of Motion and Functional Disability Among the Athletes With Planter Fasciitis
- ClinicalTrials.gov ID
- NCT06536803
- Acronym / sponsor ID
- REC/RCR&AHS/23/0471
- Keywords
- plantar heel pain,High-load strength training,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 26 Sep 2024 (estimated)
- First posted
- 5 Aug 2024 (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 rationale behind examining the synergistic impacts of high load strength training and tissues pecific plantar fascia stretching activities in athletes diagnosed with plantar fasciitis arises from an acknowledged deficiency in the existing body of scholarly research.Study design will be Randomized Control Trial. The study will be completed in 10 months after Synopsis Approval.The study will be carried in sports clubs of MOTH Mirpur AJK. Convenient Sampling will be used. Data Collection Tools will be used named as VAS, Functional foot index (FFI), and Goniometry used for Pain, functional disability and range of motion will be measured respectively before and after the intervention
Detailed description
Population is divided into 2 groups: Group A and Group B. Both groups will be given a patient evaluation sheet and thickness of planter fascia will be already measured by Ultrasound. Group A will then receive high load strength training and routine physiotherapy. Group B will receive high load strength training and Tissue-specific plantar fascia stretching exercise and routine physiotherapy. Pain, range of motion and functional disability will be measured before session, immediate effect after first session, then after 06 weeks (18 session) with high load strength training maximum repetition 12 RM with 3 sets in alternative days in each set minimum 2 mint rest interval and tissue specific plantar fascia stretching exercise perform for 10 times for 10 sec, after 12 weeks (36 sessions) with high load strength training maximum repetition 10 RM with 4 sets in alternative days in each set minimum 2 mint rest interval tissue specific plantar fascia stretching exercise perform for 10 times for 10 sedate will be entered and analyzed by SPSS version 21. Statistical significance will be p=0.05 Descriptive statistics: Frequency tables, pie charts, bar charts will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| high-load strength training with tisssue specific plantar fascia stretching exercise | Active comparator | Other: high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeksExperimental group will receive high load strength training and Tissue-specific plantar fascia stretching exercise and routine physiotherapy. Pain, range of motion and functional disability will be measured before session, immediate effect after first session,then after 06 weeks (18 session) with high load strength training maximum repetition 12 RM with 3 sets in alternative days in each set minimum 2 mint rest interval and tissue specific plantar fascia stretching exercise perform for 10 times for 10 sec, after 12 weeks (36 sessions) with high load strength training maximum repetition 10 RM with 4 sets in alternative days in each set minimum 2 mint rest interval tissue specific plantar fascia stretching exercise perform for 10times |
| high-load strength training with routine physiotherapy | Active comparator | Other: high-load strength training with routine physiotherapyactive compator group will then receive high load strength training and routine physiotherapy ultrasonic therapy |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Only Male Athletes
- Prediagnosed Patients suffering from Plantar fasciitis referred from Orthopedic.
- History of inferior heel pain atleast 2 weeks before enrollement.
- Pain on palpation of Medial calcaneal Tubercle/proximal Plantar Fascia.
- All participants with in the age group between 20-35 yrs.
Key exclusion criteria (6 listed)
- History of any systemic disease
- Heel and skin infection
- History of prior Surgery
- Corticosteroid injection for Plantar fasciitis within previous 06 momths;
- Any known malignancy /neoplasma involved side.
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 load strength training and Tissue-specific plantar fascia stretching exercise for 12 weekshigh load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks | Other | high-load strength training with tisssue specific plantar fascia stretching exercise |
| high-load strength training with routine physiotherapyhigh load strength training with routine physiotherapy for 12 weeks | Other | high-load strength training with routine physiotherapy |
Primary outcome
Range of motion
Time frame: 0 week,6 weeks ,12 week
will be measured through goniometer
functional disability measured through Foot Function Index
Time frame: 0 week,6 weeks ,12 week
will be measured through Foot Function Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 21916393Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Background: PubMed 25145882Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
- Background: PubMed 27692740Huffer D, Hing W, Newton R, Clair M. Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. Phys Ther Sport. 2017 Mar;24:44-52. doi: 10.1016/j.ptsp.2016.08.008. Epub 2016 Aug 18.
- Background: PubMed 16882901Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.
- Background: PubMed 25940060Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg. 2015 Dec;24(Pt B):135-42. doi: 10.1016/j.ijsu.2015.04.082. Epub 2015 May 1.
- Background: PubMed 18524985Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
- 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.
Muhammad ilyas 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 high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks and high-load strength training with routine physiotherapy in people with Plantar Fascitis and Resistance Training, 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 7 inclusion and 6 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 5 Aug 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 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 Muhammad Atif Javed, PP-DPT (+923317491071, atif.javed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 0 week,6 weeks ,12 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?
On the ClinicalTrials.gov record for NCT06536803, which also lists 6 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 5 Aug 2024.