NCT06437821

Brief Summary

This research aims to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. By combining economical, ergonomic principles and user-friendly features, the proposed device offers individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 25, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale (NPRS)

    A pain scale is a method used to quantify the level of discomfort a person is experiencing. It assesses a person's level of pain intensity on a scale from 0 to 10. The scale rates a person's level of discomfort at a particular moment and goes from '0', indicating no pain, to '10,' representing the worst pain imaginable. This simple yet efficient method is widely used to help healthcare professionals evaluate and treat pain.

    12 Months

  • Neck disability index (NDI)

    To evaluate a patient's functional status, ten questions are asked about their condition, including pain, personal care, lifting, reading, headaches, focus, job, driving, sleeping, and recreation. Each category is scored from 0 to 5, where 0 indicates "No pain" and 5 indicates "Worst imaginable pain." The score can be multiplied by two to get a percentage score, with a maximum score of fifty.

    12 months

Study Arms (2)

Petrissage

OTHER
Diagnostic Test: Petrissage

Graston Technique

EXPERIMENTAL
Other: Graston Technique

Interventions

PetrissageDIAGNOSTIC_TEST

The calf muscles will receive a firm, deep-circulation massage with fingertip pressure

Petrissage

The calf muscles will receive a firm, deep-circulation massage with fingertip pressure

Graston Technique

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients diagnosed with Trapezius tightness
  • Age above 18-30
  • Presence of active trigger points in the upper trapezius muscle
  • Participants who are volunteer for the study
  • Patients who suffer from shoulder pain and stiffness due to bad posture

You may not qualify if:

  • History of whiplash injury
  • History of head, neck, cervical spine or shoulder surgery
  • History of cervical radiculopathy
  • Diagnosed fibromyalgia and myopathy
  • History of cancer
  • Pregnancy Myofascial therapy within the past month
  • Contraindication of dry needling and instrument-assisted soft tissue mobilization technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Orian ABA Pakistan (Physiotherapy Department)

Lahore, Punjab Province, Pakistan

Location

Study Design

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

Study Record Dates

First Submitted

May 25, 2024

First Posted

May 31, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

October 29, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations