Heel Pain SyndromeNCT06074640
Effects of PIR With and Without Dry Needling on Heel Pain
A study testing MET PIR with Dry Needling and MET PIR without Dry Needling in people with Heel Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research will be to determine the effects of Post Isometric relaxation exercises with and without dry needling of triceps surae MTrPs on heel pain, ankle ROM and foot function in chronic heel pain patients. The sample size calculated for this study was 42. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Heel Pain Syndrome
- What is being tested?
- MET PIR with Dry Needling and MET PIR without Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Oct 2023to 30 Apr 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 40 yrs
- Both Genders (Males and Females)
- Clinical diagnosis of plantar heel pain in accordance with ICFDH
- Primary c/o unilateral heel pain on the inferomedial surface
- Pain elicited with first steps after waking
- Pain worsens on prolonged weight bearing or inactivity.
Show all 10Show fewer
- Complaint of Heel Pain ≥ 6 month (Chronic)
- NPRS score of heel pain between scores above 3
- Ankle dorsiflexion less than 10° with extended knee or less than 20° with flexed knee.
- Presence of MTrPs in any of the triceps surae muscle (Gastrocnemius, soleus) on initial inspection
Who cannot join
- Patients with bilateral heel pain (may be systemic)
- Heel pain with absence of trigger points in Triceps surae complex.
- Participants diagnosed with serious causes of heel pain. (Ankle/foot fractures, Tumors etc)
- Secondary causes of heel pain(Congenital deformity, systemic inflammatory, vascular or neurological disorders etc)
- History of treatment for heel pain in the past 4 weeks
- Persons contraindicated for Acupuncture/Dry Needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Post Isometric Relaxation With and Without Dry Needling in Triceps Surae With Chronic Heel Pain.
The aim of this research will be to determine the effects of Post Isometric relaxation exercises with and without dry needling of triceps surae MTrPs on heel pain, ankle ROM and foot function in chronic heel pain patients. The sample size calculated for this study was 42. The subjects will be divided in two groups, 21 subjects in PIR with dry needling group and 21 in PIR without dry needling group. Study duration will be of 6 months. Sampling technique applied will be non probability convenience sampling technique. Only patients who are 20 - 40 years old, have NPRS score of heel pain above 3 and have MTrPs in any of the triceps surae muscle on initial inspection are included. Tools used in the study are Goniometer, NPRS scale and Foot function Index. Data will be analyzed through SPSS 23.
Read the detailed description
A number of patients visit clinics with a common subjective complaint of heel pain, especially with advancing age. Chronic PHP is characterized by painful inferioromedial aspect of calcaeneum, tender to even palpation. Myofascial pain syndrome cause regional pain and its hallmark feature is the presence of trigger points in the affected muscles. Triggers points in triceps surae i.e. Gastro-soleus can generate symptoms in the vicinity or spill them over to heel, causing pain and restricted mobility. Manual therapy and acupuncture are tools to deactivate MTrPs whilst restoring the muscle to its normal length and full joint range of motion with exercises and stretches. Dry needling treats trigger points by disrupting the tender points; whereas Post isometric relaxation is a form of muscle energy technique that restores the stretch length of a shortened, hypertonic muscle thereby decreasing myofascial pain. The aim of current RCT will be to compare the effects of post isometric relaxation with and without dry needling for trigger points of triceps surae in chronic heel pain patients.
Former studies have been conducted to explore the effects of various conventional and complementary therapies for heel pain rehabilitation. These studies provide evidence for the effectiveness of Muscle energy techniques and dry needling, as isolated treatments, in improving outcome measures for heel pain. Sufficient evidence also supports the efficacy of manual therapies with dry needling for neck pain, low back pain, knee or shoulder pain etc but is scarce for heel pain cases. Our study will apply multimodal approach by combining conventional stretching exercise and MET PIR with dry needling. Evidence of such a study published previously is almost negligible for heel pain rehab
- Conditions
- Heel Pain Syndrome
- Being tested
- MET PIR with Dry Needling, MET PIR without Dry Needling
- Keywords
- chronic heel pain, dry needling, post isometric relaxation, tricep surae, trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET PIR with Dry NeedlingOther
MET PIR Protocol: The subject will be asked to exert a small effort (20% of available strength) towards plantar flexion, against unyielding resistance, for 20 seconds. Once released, ankle will be dorsiflexed beyond the new range gained and stretched for up to 30 seconds. Rest period will be of 1 minute in between each repetition. (3 Repetitions, 1 Sets, 3 days per week, for 4 weeks consecutively.) MTrPs will be identified and located using flat or pincer palpation method in the Triceps Surae complex of the affected leg. The identified trigger points will be marked with a marker. Piston technique of dry needling is performed on the identified MTrPs in calf muscles. The self stretches of Plantar Fascia and Calf muscles will be demonstrated. The stretch position will be maintained for 20 sec, followed by 20 sec rest and then repeated for 3 minutes. All stretches will be performed twice daily by patients for 4 weeks time period (3 Reps, 2 sets/day, for 4 weeks)
MET PIR without Dry NeedlingOther
MET PIR Protocol: The subject will be asked to exert a small effort (20% of available strength) towards plantar flexion, against unyielding resistance, for 20 seconds. Once released, ankle will be dorsiflexed beyond the new range gained and stretched for up to 30 seconds. Rest period will be of 1 minute in between each repetition. (3 Repetitions, 1 Sets, 3 days per week, for 4 weeks consecutively.) The self stretches of Plantar Fascia and Calf muscles will be demonstrated. The stretch position will be maintained for 20 sec, followed by 20 sec rest and then repeated for 3 minutes. All stretches will be performed twice daily by patients for 4 weeks time period (3 Reps, 2 sets/day, for 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| interventional group 1(MET PIR with Dry needling) | Experimental | Participants of this group will be treated with a MET protocol, and a dry needling session for Calf muscles MTrPs. Home regimen of self stretches for Calf muscles and plantar fascia will be given to patients Receives: Other: MET PIR with Dry Needling |
| interventional group II (MET PIR without dry needling) | Experimental | participants will follow the same MET PIR exercises but without adjunct dry needling for Calf muscles. Home regimen of self stretches for Calf muscles and plantar fascia will be given to patients Receives: Other: MET PIR without Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heel Pain
Heel pain scoring via NPRS Scale. This 11-point scale ranges from "0" interpreted as "No pain" to "10' interpreted as "worst imaginable pain" Change will be measured from baseline to 4 weeks.
Measured: 4 weeks
Ankle Dorsiflexion ROM
Universal goniometer measurements of dorsiflexion range at Ankle. It has markings on its surface from 0° to 360° to measure ankle range of motion. Change will be measured from baseline to 4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Foot Function
Foot function index is used to assess foot function level. The FFI Questionnaire consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Change will be measured from baseline to 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Pain SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Ashraf, TDPT, Principal investigator, Riphah International UniversityMaham Khurshid, MS OMPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074640
- Sponsor's protocol ID
- REC/0163Maham Khurshid
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2023
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post Isometric Relaxation With and Without Dry Needling in Triceps Surae With Chronic Heel Pain.
- ClinicalTrials.gov ID
- NCT06074640
- Acronym / sponsor ID
- REC/0163Maham Khurshid
- Conditions
- Heel Pain Syndrome
- Keywords
- chronic heel pain, dry needling, post isometric relaxation, tricep surae, trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Oct 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 aim of this research will be to determine the effects of Post Isometric relaxation exercises with and without dry needling of triceps surae MTrPs on heel pain, ankle ROM and foot function in chronic heel pain patients. The sample size calculated for this study was 42. The subjects will be divided in two groups, 21 subjects in PIR with dry needling group and 21 in PIR without dry needling group. Study duration will be of 6 months. Sampling technique applied will be non probability convenience sampling technique. Only patients who are 20 - 40 years old, have NPRS score of heel pain above 3 and have MTrPs in any of the triceps surae muscle on initial inspection are included. Tools used in the study are Goniometer, NPRS scale and Foot function Index. Data will be analyzed through SPSS 23.
Detailed description
A number of patients visit clinics with a common subjective complaint of heel pain, especially with advancing age. Chronic PHP is characterized by painful inferioromedial aspect of calcaeneum, tender to even palpation. Myofascial pain syndrome cause regional pain and its hallmark feature is the presence of trigger points in the affected muscles. Triggers points in triceps surae i.e. Gastro-soleus can generate symptoms in the vicinity or spill them over to heel, causing pain and restricted mobility. Manual therapy and acupuncture are tools to deactivate MTrPs whilst restoring the muscle to its normal length and full joint range of motion with exercises and stretches. Dry needling treats trigger points by disrupting the tender points; whereas Post isometric relaxation is a form of muscle energy technique that restores the stretch length of a shortened, hypertonic muscle thereby decreasing myofascial pain. The aim of current RCT will be to compare the effects of post isometric relaxation with and without dry needling for trigger points of triceps surae in chronic heel pain patients.
Former studies have been conducted to explore the effects of various conventional and complementary therapies for heel pain rehabilitation. These studies provide evidence for the effectiveness of Muscle energy techniques and dry needling, as isolated treatments, in improving outcome measures for heel pain. Sufficient evidence also supports the efficacy of manual therapies with dry needling for neck pain, low back pain, knee or shoulder pain etc but is scarce for heel pain cases. Our study will apply multimodal approach by combining conventional stretching exercise and MET PIR with dry needling. Evidence of such a study published previously is almost negligible for heel pain rehab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group 1(MET PIR with Dry needling) | Experimental | Other: MET PIR with Dry NeedlingParticipants of this group will be treated with a MET protocol, and a dry needling session for Calf muscles MTrPs. Home regimen of self stretches for Calf muscles and plantar fascia will be given to patients |
| interventional group II (MET PIR without dry needling) | Experimental | Other: MET PIR without Dry Needlingparticipants will follow the same MET PIR exercises but without adjunct dry needling for Calf muscles. Home regimen of self stretches for Calf muscles and plantar fascia will be given to patients |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 20 to 40 yrs
- Both Genders (Males and Females)
- Clinical diagnosis of plantar heel pain in accordance with ICFDH
- Primary c/o unilateral heel pain on the inferomedial surface
- Pain elicited with first steps after waking
Key exclusion criteria (6 listed)
- Patients with bilateral heel pain (may be systemic)
- Heel pain with absence of trigger points in Triceps surae complex.
- Participants diagnosed with serious causes of heel pain. (Ankle/foot fractures, Tumors etc)
- Secondary causes of heel pain(Congenital deformity, systemic inflammatory, vascular or neurological disorders etc)
- History of treatment for heel pain in the past 4 weeks
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 |
|---|---|---|
| MET PIR with Dry NeedlingMET PIR Protocol: The subject will be asked to exert a small effort (20% of available strength) towards plantar flexion, against unyielding resistance, for 20 seconds. Once released, ankle will be dorsiflexed beyond the new range gained and stretched for up to 30 seconds. Rest period will be of 1 minute in between each repetition. (3 Repetitions, 1 Sets, 3 days per week, for 4 weeks consecutively.) MTrPs will be identified and located using flat or pincer palpation method in the Triceps Surae complex of the affected leg. The identified trigger points will be marked with a marker. Piston technique of dry needling is performed on the identified MTrPs in calf muscles. The self stretches of Plantar Fascia and Calf muscles will be demonstrated. The stretch position will be maintained for 20 sec, followed by 20 sec rest and then repeated for 3 minutes. All stretches will be performed twice daily by patients for 4 weeks time period (3 Reps, 2 sets/day, for 4 weeks) | Other | interventional group 1(MET PIR with Dry needling) |
| MET PIR without Dry NeedlingMET PIR Protocol: The subject will be asked to exert a small effort (20% of available strength) towards plantar flexion, against unyielding resistance, for 20 seconds. Once released, ankle will be dorsiflexed beyond the new range gained and stretched for up to 30 seconds. Rest period will be of 1 minute in between each repetition. (3 Repetitions, 1 Sets, 3 days per week, for 4 weeks consecutively.) The self stretches of Plantar Fascia and Calf muscles will be demonstrated. The stretch position will be maintained for 20 sec, followed by 20 sec rest and then repeated for 3 minutes. All stretches will be performed twice daily by patients for 4 weeks time period (3 Reps, 2 sets/day, for 4 weeks) | Other | interventional group II (MET PIR without dry needling) |
Primary outcome
Heel Pain
Time frame: 4 weeks
Heel pain scoring via NPRS Scale. This 11-point scale ranges from "0" interpreted as "No pain" to "10' interpreted as "worst imaginable pain" Change will be measured from baseline to 4 weeks.
Ankle Dorsiflexion ROM
Time frame: 4 weeks
Universal goniometer measurements of dorsiflexion range at Ankle. It has markings on its surface from 0° to 360° to measure ankle range of motion. Change will be measured from baseline to 4 weeks.
1 secondary outcome
Foot Function
Time frame: 4 weeks
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 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Heel Pain Syndrome
Not yet recruiting
Acupuncture for Heel Pain Syndrome
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Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
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Not yet recruiting
Effect of Kaltenborn vs Mulligan Mobilization With Intrinsic Foot Strengthening in 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.
Faiza Ashraf, TDPT principal investigator
Riphah International University
Maham Khurshid, MS OMPT* 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 MET PIR with Dry Needling and MET PIR without Dry Needling in people with Heel Pain Syndrome, 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 10 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: finished, as of the sponsor's last update on 8 Apr 2025. 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?
Heel Pain (time frame: 4 weeks). 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 8 Apr 2025.