NCT06074640

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

October 3, 2023

Last Update Submit

April 7, 2025

Conditions

Keywords

chronic heel paindry needlingpost isometric relaxationtricep suraetrigger points

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 weeks

Secondary Outcomes (1)

  • Foot Function

    4 weeks

Study Arms (2)

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

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

Other: MET PIR without Dry Needling

Interventions

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)

interventional group 1(MET PIR with Dry needling)

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)

interventional group II (MET PIR without dry needling)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Bashir Hospital

Ghakhar, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Faiza Ashraf, TDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Maham Khurshid, MS OMPT*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

October 3, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations