NCT05810818

Brief Summary

To determine the effectiveness of dry needling and soft tissue mobilization with self-stretching for the management of calf and heel pain. In our topic pain and physical dysfunction are our variables

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

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

March 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 15, 2023

Last Update Submit

March 31, 2023

Conditions

Heel Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Dry Needling and Soft Tissue Mobilization with Self-Stretching

    Effectiveness Of Dry Needling and Soft Tissue Mobilization Combined with Self-Stretching for Management of Calf and Heel Pain

    6 Months

Study Arms (2)

Dry needling along stretches and soft tissues therapy

EXPERIMENTAL
Diagnostic Test: Dry Needling

stretching and soft tissue mobilization

ACTIVE COMPARATOR
Diagnostic Test: Self Stretching

Interventions

Dry NeedlingDIAGNOSTIC_TEST

Dry needling treatment will be consisting of two treatments per week

Dry needling along stretches and soft tissues therapy
Self StretchingDIAGNOSTIC_TEST

Self stretching groups both will receive a TrP manual interventions and stretching protocol

stretching and soft tissue mobilization

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be between the ages of 25 to 60 years.
  • Female and males.
  • History of heel and calf pain.
  • Pain level moderate .
  • Trigger point / inactive trigger points.
  • Acute stage patients.

You may not qualify if:

  • Phobias like injections or needles.
  • Unwilling patients
  • Patients on anticoagulant medicines.
  • Patients with RA
  • Fibromyalgia syndrome.
  • Pateint with recent trauma and surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share