NCT07525921

Brief 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. 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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).

Secondary Outcomes (1)

  • Range of Motion of Ankle Dorsiflexion

    Baseline (Day 0, pre-intervention) and Immediately Post-intervention (within 15 minutes after intervention).

Study Arms (2)

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.

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.

Procedure: Sham Needling

Interventions

Dry NeedlingPROCEDURE

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.

Group A - Dry Needling Group
Sham NeedlingPROCEDURE

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.

Also known as: Placebo Needling
Group B - Sham Needling Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Hamza Aliyan, DPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamza Aliyan, DPT

CONTACT

Marwa Asim, MS-OMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to treatment allocation. The sham procedure mimics the sensation and setup of dry needling without skin penetration to maintain participant blinding, while the treating therapist cannot be blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

August 29, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-02

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