Plantar FascitisNCT06706531
Additional Effects of Dry Needling With Conventional Physical Therapy Versus Conventional Physical Therapy in Plantar Fasciitis: a Randomized Control Trial
A study testing Standard treatment and Dry needling in people with Plantar Fascitis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomized controlled trial and the purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis: a randomized control trial. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Standard treatment and Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-60 years
- Both genders
- Plantar heel pain for longer than 3 months
- Pain score at least or less than 8 on the numeric pain (NPRS)
- Clinical diagnosis of unilateral PF in accordance with the clinical practice guidelines from the Orthopaedic Section of the American Physical Therapy Association APTA:
- Plantar medial heel pain: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing
Show all 13Show fewer
- Heel pain precipitated by a recent increase in weight bearing activity
- Pain with palpation of the proximal insertion of the plantar fascia
- Positive windlass test
- Negative tarsal tunnel tests
- Limited active and passive talocrural joint dorsiflexion range of motion
- Abnormal foot posture index score
- High body mass index in nonathletic individuals
Who cannot join
- Positive ankle drawer tests
- Pregnant womwn, mental illness, immune suppressed patients, thrombocytopenia, anti-coagulant therapy patients and post-mastectomy
- Congenital abnormalities of foot
- A history of surgery to the ankle, foot or lower leg
- Other causes of heel pain (including tarsal tunnel syndrome, calcaneal fracture, ankle or foot instability, arthritis of the foot or ankle, rheumatoid arthritis, spondyloarthropathy, gout,peripheral neuropathy )
- Presented with 2 or more positive neurologic signs consistent with nerve root compression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Qurat ul Ain Saeed, MS-OMPT,PHD*, 03315562889, quratulain.saeed@fui.edu.pk
About this study
This study is a randomized controlled trial and the purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis: a randomized control trial.
Read the detailed description
The purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis Outcomes variables of Pain , Ankle ROM, gait parameters and activities of daily living in adults (age : 40-60 years ) will be determined using:
- Numeric pain rating scale
- Goniometer
- 30 meter walk test
- foot and ankle ability measure FAAM Data will be before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.
- Conditions
- Plantar Fascitis
- Being tested
- Standard treatment, Sham Dry needling, Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentProcedure or surgery
All participants received up to six treatment sessions at a frequency of twice per week over a 3-week period i.e. ultrasound (0.5 W/cm² of 3 MHz for 5 minutes over plantar aspect of foot), stretching exercises and strengthening exercises. The exercise pro
Sham Dry needlingProcedure or surgery
The sham dry needling group will also receive 6 sessions of sham dry needling on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes.Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm.The plantar and medial surface of the foot and ankle will be cleaned with alcohol. The sham dry needling will be performed for 5 minutes.
Dry needlingProcedure or surgery
The dry needling group will receive 6 sessions of dry needling using a standardized trigger point protocol on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes. Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm. The calf, plantar and medial surface of the foot and ankle will be cleaned with alcohol. Following insertion, needles will be manipulated bi-directionally to elicit a sensation of aching, tingling, deep pressure, heaviness or warmth. The needles will then left in situ for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + Sham Dry needling | Active comparator | Participants will receive standard treatment of plantar facitis along with sham dry needling Receives: Procedure: Standard treatment; Procedure: Sham Dry needling |
| Standard treatment + Dry needling | Experimental | Participants will receive standard treatment of plantar facitis along with dry needling Receives: Procedure: Standard treatment; Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain will be measured on Numerical Pain rating scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 3 weeks
The Foot and Ankle Ability Measure (FAAM)
It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments .The response to each item on the ADL subscale is scored from 4 to 0, with 4 being 'no difficulty' and 0 being 'unable to do'
Measured: 3 weeks
Gait speed:
Gait speed = Distance (m) / time (s)
Measured: 3 weeks
Cadence
Cadence (steps/min) = steps counted x 60 / time (s)
Measured: 3 weeks
Cycle length
Cycle time (s) = time (s) x 2/steps counted
Measured: 3 weeks
Stride length
SL (m) = speed (m/s) x cycle time (s)
Measured: 3 weeks
Range of motion
Ankle range will be measured with goniometer
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706531
- Sponsor's protocol ID
- FUI/CTR/2024/53
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Dry Needling With Conventional Physical Therapy Versus Conventional Physical Therapy in Plantar Fasciitis: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06706531
- Acronym / sponsor ID
- FUI/CTR/2024/53
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Nov 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.
This study is a randomized controlled trial and the purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis: a randomized control trial.
Detailed description
The purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis Outcomes variables of Pain , Ankle ROM, gait parameters and activities of daily living in adults (age : 40-60 years ) will be determined using:
- Numeric pain rating scale
- Goniometer
- 30 meter walk test
- foot and ankle ability measure FAAM Data will be before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + Sham Dry needling | Active comparator | Procedure: Standard treatment, Procedure: Sham Dry needlingParticipants will receive standard treatment of plantar facitis along with sham dry needling |
| Standard treatment + Dry needling | Experimental | Procedure: Standard treatment, Procedure: Dry needlingParticipants will receive standard treatment of plantar facitis along with dry needling |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 40-60 years
- Both genders
- Plantar heel pain for longer than 3 months
- Pain score at least or less than 8 on the numeric pain (NPRS)
- Clinical diagnosis of unilateral PF in accordance with the clinical practice guidelines from the Orthopaedic Section of the American Physical Therapy Association APTA:
Key exclusion criteria (6 listed)
- Positive ankle drawer tests
- Pregnant womwn, mental illness, immune suppressed patients, thrombocytopenia, anti-coagulant therapy patients and post-mastectomy
- Congenital abnormalities of foot
- A history of surgery to the ankle, foot or lower leg
- Other causes of heel pain (including tarsal tunnel syndrome, calcaneal fracture, ankle or foot instability, arthritis of the foot or ankle, rheumatoid arthritis, spondyloarthropathy, gout,peripheral neuropathy )
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 |
|---|---|---|
| Standard treatmentAll participants received up to six treatment sessions at a frequency of twice per week over a 3-week period i.e. ultrasound (0.5 W/cm² of 3 MHz for 5 minutes over plantar aspect of foot), stretching exercises and strengthening exercises. The exercise pro | Procedure or surgery | Standard treatment + Dry needling, Standard treatment + Sham Dry needling |
| Sham Dry needlingThe sham dry needling group will also receive 6 sessions of sham dry needling on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes.Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm.The plantar and medial surface of the foot and ankle will be cleaned with alcohol. The sham dry needling will be performed for 5 minutes. | Procedure or surgery | Standard treatment + Sham Dry needling |
| Dry needlingThe dry needling group will receive 6 sessions of dry needling using a standardized trigger point protocol on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes. Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm. The calf, plantar and medial surface of the foot and ankle will be cleaned with alcohol. Following insertion, needles will be manipulated bi-directionally to elicit a sensation of aching, tingling, deep pressure, heaviness or warmth. The needles will then left in situ for 5 minutes. | Procedure or surgery | Standard treatment + Dry needling |
Primary outcome
Pain intensity
Time frame: 3 weeks
Pain will be measured on Numerical Pain rating scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
The Foot and Ankle Ability Measure (FAAM)
Time frame: 3 weeks
It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments .The response to each item on the ADL subscale is scored from 4 to 0, with 4 being 'no difficulty' and 0 being 'unable to do'
Gait speed:
Time frame: 3 weeks
Gait speed = Distance (m) / time (s)
Cadence
Time frame: 3 weeks
Cadence (steps/min) = steps counted x 60 / time (s)
Cycle length
Time frame: 3 weeks
Cycle time (s) = time (s) x 2/steps counted
Stride length
Time frame: 3 weeks
SL (m) = speed (m/s) x cycle time (s)
Range of motion
Time frame: 3 weeks
Ankle range will be measured with goniometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment and Dry needling in people with Plantar Fascitis, run by Foundation University Islamabad 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 13 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: looking for participants now, as of the sponsor's last update on 26 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areeba Michelle, MS-MSKPT* (0334-8546616, aribaa.michelle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 3 weeks). The study lists 7 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 26 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.