- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525921
Immediate Effect of Dry Needling on Calf Muscles Pain Pressure Threshold,Sprint Speed and Functional Performance in Amateur Football Player
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hamza Aliyan, DPT
- Phone Number: 03209092006
- Email: Hamza.aalyaan@gmail.com
Study Contact Backup
- Name: Marwa Asim, MS-OMPT
- Email: marwa@fui.edu.pk
Study Locations
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Hamza Aliyan, DPT
- Phone Number: 03209092006
- Email: Hamza.aalyaan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A - Dry Needling Group
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.
|
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.
|
|
Experimental: Group B - Sham Needling Group
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
|
|
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.
|
Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
|
|
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. |
Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion of Ankle Dorsiflexion
Time Frame: Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
|
Ankle dorsiflexion will be measured in degrees using a universal goniometer.
Three readings will be taken and averaged.
Higher degrees indicate improved flexibility.
|
Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamza Aliyan, DPT, Foundation University Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/FUCP/CTR/01.26/HamzaAliyan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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