Effects of PIR With and Without Dry Needling on Heel Pain

Effects of Post Isometric Relaxation With and Without Dry Needling in Triceps Surae With Chronic Heel Pain.

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.

Study Overview

• Status: Recruiting
• Conditions: Heel Pain Syndrome
• Intervention / Treatment: Other: MET PIR with Dry Needling; Other: MET PIR without Dry Needling

Detailed Description

A number of patients visit clinics with a common subjective complaint of heel pain, especially with advancing age. Chronic PHP is characterized by painful inferioromedial aspect of calcaeneum, tender to even palpation. Myofascial pain syndrome cause regional pain and its hallmark feature is the presence of trigger points in the affected muscles. Triggers points in triceps surae i.e. Gastro-soleus can generate symptoms in the vicinity or spill them over to heel, causing pain and restricted mobility. Manual therapy and acupuncture are tools to deactivate MTrPs whilst restoring the muscle to its normal length and full joint range of motion with exercises and stretches. Dry needling treats trigger points by disrupting the tender points; whereas Post isometric relaxation is a form of muscle energy technique that restores the stretch length of a shortened, hypertonic muscle thereby decreasing myofascial pain. The aim of current RCT will be to compare the effects of post isometric relaxation with and without dry needling for trigger points of triceps surae in chronic heel pain patients.

Former studies have been conducted to explore the effects of various conventional and complementary therapies for heel pain rehabilitation. These studies provide evidence for the effectiveness of Muscle energy techniques and dry needling, as isolated treatments, in improving outcome measures for heel pain. Sufficient evidence also supports the efficacy of manual therapies with dry needling for neck pain, low back pain, knee or shoulder pain etc but is scarce for heel pain cases. Our study will apply multimodal approach by combining conventional stretching exercise and MET PIR with dry needling. Evidence of such a study published previously is almost negligible for heel pain rehab

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aruba Saeed, PHD*; Phone Number: 03344399403; Email: aruba.saeed@riphah.edu.pk
• Study Contact Backup: Name: Faiza Ashraf, TDPT; Phone Number: 03327673643; Email: dr.faiza1234@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Ghakhar, Punjab, Pakistan
      • Recruiting
      • Fatima Bashir Hospital
      • Contact: Faiza Ashraf, TDPT; Phone Number: 03327673643; Email: dr.faiza1234@gmail.com
      • Principal Investigator: Maham Khurshid, MS OMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group 1(MET PIR with Dry needling); 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; 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)
Experimental: interventional group II (MET PIR without dry needling); 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function	Foot function index is used to assess foot function level. The FFI Questionnaire consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Change will be measured from baseline to 4 weeks.	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Faiza Ashraf, TDPT, Riphah International University; Principal Investigator: Maham Khurshid, MS OMPT*, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: trigger points; dry needling; post isometric relaxation; chronic heel pain; tricep surae
• Other Study ID Numbers: REC/0163Maham Khurshid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No