Myofascial Pain SyndromesNCT07525921
Immediate Effect of Dry Needling on Calf Muscles Pain Pressure Threshold,Sprint Speed and Functional Performance in Amateur Football Player
A study testing Dry Needling in people with Myofascial Pain Syndromes and Trigger Points, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This randomised single-blind trial will evaluate the immediate effect of a single session of dry needling versus sham needling on calf muscle myofascial trigger points among amateur football players aged 18-25 years. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Myofascial Pain Syndromes, Trigger Points, Gastrocnemius Muscle
- What is being tested?
- Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Aug 2025to 1 Jun 2026
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Amateur football players aged 18-25 years.
- Participation in club-level football for at least one year.
- Presence of active myofascial trigger point in gastrocnemius or soleus confirmed by palpation.
- Willingness to participate and provide informed consent.
Who cannot join
- History of calf muscle tear, fracture, or lower limb surgery.
- Current use of muscle relaxants or anti-inflammatory medication.
- Known bleeding disorders or anticoagulant therapy.
- Local infection, skin lesion, or contraindication to dry needling.
- Neurological or vascular disorders affecting lower limb function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marwa Asim, MS-OMPT contact
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, Punjab Province, 46000
Hamza Aliyan, DPT, 03209092006, Hamza.aalyaan@gmail.com
About this study
This randomised single-blind trial will evaluate the immediate effect of a single session of dry needling versus sham needling on calf muscle myofascial trigger points among amateur football players aged 18-25 years. Primary and secondary outcomes are Pressure Pain Threshold (algometer), Sprint Speed (shuttle run test), and Functional Performance (single-leg hop). Outcomes will be measured immediately pre- and post-intervention. Data analysis will be performed in SPSS version 27 using paired and independent t-tests (p < 0.05).
Read the detailed description
A randomised, single-blind, parallel-group trial recruiting amateur club football players (age 18-25) with active myofascial trigger points in gastrocnemius or soleus. Participants randomised (coin toss) into Group A (Dry Needling) or Group B (Sham Needling). Baseline measures: Pressure Pain Threshold (PPT) using handheld algometer, ankle dorsiflexion ROM with goniometer, sprint speed via shuttle run, and single-leg hop distance. Intervention: a single session of dry needling (sterile single-use filiform needles 0.25-0.30 mm; needles retained ~10 minutes with fast-in/fast-out pistoning to elicit local twitch response) or a non-penetrating sham procedure mimicking needling. Post-intervention assessments are performed immediately after the session. Data will be analysed with SPSS v.27; paired t-tests for within-group and independent t-tests for between-group comparisons (p < 0.05).
- Being tested
- Dry Needling, Sham Needling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
A single-session myofascial trigger point dry needling treatment will be administered to identified trigger points in the gastrocnemius and/or soleus muscles using sterile disposable filiform needles. The objective is to mechanically disrupt the dysfunctional motor end plate, elicit local twitch responses, reduce nociceptive activity, and restore muscle function. The intervention is delivered under aseptic conditions by a trained physiotherapist following standard safety guidelines. Post-procedure monitoring will be conducted for minor adverse effects such as soreness or bleeding.
Sham NeedlingProcedure or surgery
Also called Placebo Needling
A simulated needling procedure designed to act as a placebo comparator will be applied without skin penetration. The technique reproduces the visual, tactile, and contextual components of dry needling to maintain participant blinding while avoiding physiological stimulation of the muscle. This allows isolation of the true therapeutic effect of dry needling from psychological or expectancy-related responses.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Dry Needling Group | Experimental | Participants with active trigger points in the gastrocnemius or soleus will receive dry needling using sterile, single-use filiform needles (0.25-0.30 mm diameter; lengths 30-50 mm chosen per muscle depth). Needles inserted nearly perpendicular (or 45-60° oblique when approaching from side to avoid neurovascular structures) to the skin into identified trigger points using a fast-in/fast-out (pistoning) technique to elicit local twitch responses. Insertion depth typically 1-4 cm. Once local twitch response elicited (or after a maximum of ~5 attempts), the needle will remain in place and needles retained for approximately 10 minutes. Needling will be performed with standard infection-control measures (skin disinfection, gloves, sterile disposal). Single session of ~10-15 minutes. Receives: Procedure: Dry Needling |
| Group B - Sham Needling Group | Experimental | Sham needling will use a non-penetrating blunted needle housed in an introducer tube placed against the skin over the trigger point. Tactile and auditory cues mimic real needling (a quick tap), but no skin penetration occurs. Pressure, duration, positioning and therapist contact will match the dry needling group. Single session of equal duration. Receives: Procedure: Sham Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold
Pressure Pain Threshold will be measured at the identified myofascial trigger point in the gastrocnemius or soleus using a handheld pressure algometer. The participant will indicate the point at which applied pressure first becomes painful. The recorded value (kg/cm²) reflects mechanical pain sensitivity of the trigger point.
Measured: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Functional Performance
Functional performance will be assessed using Single leg hop test ( distance in centimeters).The Single Leg Hop Test measures lower limb explosive power. Participants will perform three maximal forward hops on one leg. The distance (in centimeters) from the starting line to the heel landing point will be recorded. The average of three trials will be used for analysis. Greater distance indicates improved functional performance.
Measured: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Sprint Speed
Sprint speed will be accessed by Shuttle run test. The speed and agility of lower limb in calf muscle by time taken to complete a short distance shuttle sprint. It reflects the explosive function of calf muscle which is essential for acceleration and direction change in football.
Sprint speed will be assessed using a 20-meter shuttle run test. Participants will run back and forth between two markers placed 20 meters apart as quickly as possible. Two trials will be performed, and the fastest time (in seconds) will be recorded to the nearest 0.1 second. Lower time indicates better sprint performance.
Measured: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Secondary outcomes (1)
Range of Motion of Ankle Dorsiflexion
Ankle dorsiflexion will be measured in degrees using a universal goniometer. Three readings will be taken and averaged. Higher degrees indicate improved flexibility.
Measured: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start29 Aug 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies 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
- Participant will be randomly allocated into two parallel groups; Group A: Dry needling intervention Group B : Sham Needling Control Both Group will undergo baseline assessment followed by a single treatment session and immediate post intervention reassessment. Outcomes will be compared between group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamza Aliyan, DPT, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525921
- Sponsor's protocol ID
- FUI/FUCP/CTR/01.26/HamzaAliyan
- Status last verified
- Feb 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Dry Needling on Calf Muscles Pain Pressure Threshold,Sprint Speed and Functional Performance in Amateur Football Player
- ClinicalTrials.gov ID
- NCT07525921
- Acronym / sponsor ID
- FUI/FUCP/CTR/01.26/HamzaAliyan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Apr 2026 (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 randomised single-blind trial will evaluate the immediate effect of a single session of dry needling versus sham needling on calf muscle myofascial trigger points among amateur football players aged 18-25 years. Primary and secondary outcomes are Pressure Pain Threshold (algometer), Sprint Speed (shuttle run test), and Functional Performance (single-leg hop). Outcomes will be measured immediately pre- and post-intervention. Data analysis will be performed in SPSS version 27 using paired and independent t-tests (p < 0.05).
Detailed description
A randomised, single-blind, parallel-group trial recruiting amateur club football players (age 18-25) with active myofascial trigger points in gastrocnemius or soleus. Participants randomised (coin toss) into Group A (Dry Needling) or Group B (Sham Needling). Baseline measures: Pressure Pain Threshold (PPT) using handheld algometer, ankle dorsiflexion ROM with goniometer, sprint speed via shuttle run, and single-leg hop distance. Intervention: a single session of dry needling (sterile single-use filiform needles 0.25-0.30 mm; needles retained ~10 minutes with fast-in/fast-out pistoning to elicit local twitch response) or a non-penetrating sham procedure mimicking needling. Post-intervention assessments are performed immediately after the session. Data will be analysed with SPSS v.27; paired t-tests for within-group and independent t-tests for between-group comparisons (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participant will be randomly allocated into two parallel groups; Group A: Dry needling intervention Group B : Sham Needling Control Both Group will undergo baseline assessment followed by a single treatment session and immediate post intervention reassessment. Outcomes will be compared between group.
| Arm | Type | Receives |
|---|---|---|
| Group A - Dry Needling Group | Experimental | Procedure: Dry NeedlingParticipants with active trigger points in the gastrocnemius or soleus will receive dry needling using sterile, single-use filiform needles (0.25-0.30 mm diameter; lengths 30-50 mm chosen per muscle depth). Needles inserted nearly perpendicular (or 45-60° oblique when approaching from side to avoid neurovascular structures) to the skin into identified trigger points using a fast-in/fast-out (pistoning) technique to elicit local twitch responses. Insertion depth typically 1-4 cm. Once local twitch response elicited (or after a maximum of ~5 attempts), the needle will remain in place and needles retained for approximately 10 minutes. Needling will be performed with standard infection-control measures (skin disinfection, gloves, sterile disposal). Single session of ~10-15 minutes. |
| Group B - Sham Needling Group | Experimental | Procedure: Sham NeedlingSham needling will use a non-penetrating blunted needle housed in an introducer tube placed against the skin over the trigger point. Tactile and auditory cues mimic real needling (a quick tap), but no skin penetration occurs. Pressure, duration, positioning and therapist contact will match the dry needling group. Single session of equal duration. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Amateur football players aged 18-25 years.
- Participation in club-level football for at least one year.
- Presence of active myofascial trigger point in gastrocnemius or soleus confirmed by palpation.
- Willingness to participate and provide informed consent.
Key exclusion criteria (5 listed)
- History of calf muscle tear, fracture, or lower limb surgery.
- Current use of muscle relaxants or anti-inflammatory medication.
- Known bleeding disorders or anticoagulant therapy.
- Local infection, skin lesion, or contraindication to dry needling.
- Neurological or vascular disorders affecting lower limb function.
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 |
|---|---|---|
| Dry NeedlingA single-session myofascial trigger point dry needling treatment will be administered to identified trigger points in the gastrocnemius and/or soleus muscles using sterile disposable filiform needles. The objective is to mechanically disrupt the dysfunctional motor end plate, elicit local twitch responses, reduce nociceptive activity, and restore muscle function. The intervention is delivered under aseptic conditions by a trained physiotherapist following standard safety guidelines. Post-procedure monitoring will be conducted for minor adverse effects such as soreness or bleeding. | Procedure or surgery | Group A - Dry Needling Group |
| Sham NeedlingAlso: Placebo NeedlingA simulated needling procedure designed to act as a placebo comparator will be applied without skin penetration. The technique reproduces the visual, tactile, and contextual components of dry needling to maintain participant blinding while avoiding physiological stimulation of the muscle. This allows isolation of the true therapeutic effect of dry needling from psychological or expectancy-related responses. | Procedure or surgery | Group B - Sham Needling Group |
Primary outcome
Pain Pressure Threshold
Time frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Pressure Pain Threshold will be measured at the identified myofascial trigger point in the gastrocnemius or soleus using a handheld pressure algometer. The participant will indicate the point at which applied pressure first becomes painful. The recorded value (kg/cm²) reflects mechanical pain sensitivity of the trigger point.
Functional Performance
Time frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Functional performance will be assessed using Single leg hop test ( distance in centimeters).The Single Leg Hop Test measures lower limb explosive power. Participants will perform three maximal forward hops on one leg. The distance (in centimeters) from the starting line to the heel landing point will be recorded. The average of three trials will be used for analysis. Greater distance indicates improved functional performance.
Sprint Speed
Time frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
Sprint speed will be accessed by Shuttle run test. The speed and agility of lower limb in calf muscle by time taken to complete a short distance shuttle sprint. It reflects the explosive function of calf muscle which is essential for acceleration and direction change in football. Sprint speed will be assessed using a 20-meter shuttle run test. Participants will run back and forth between two markers placed 20 meters apart as quickly as possible. Two trials will be performed, and the fastest time (in seconds) will be recorded to the nearest 0.1 second. Lower time indicates better sprint performance.
1 secondary outcome
Range of Motion of Ankle Dorsiflexion
Time frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
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 13 Apr 2026.
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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.
Marwa Asim, MS-OMPT contact
Hamza Aliyan, DPT principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Myofascial Pain Syndromes and Trigger Points, 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 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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 Hamza Aliyan, DPT (03209092006, Hamza.aalyaan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold (time frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).). The study lists 3 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 13 Apr 2026.