NCT06905743

Brief Summary

Achilles tendinopathy is a common overuse injury that leads to pain and functional limitations. Traditional rehabilitation focuses on eccentric strengthening, which has been widely studied for its benefits in promoting tendon remodeling and improving strength. However, recent research suggests that isometric contractions may offer superior pain modulation effects, especially in the early stages of rehabilitation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • NUMERIC PAIN RATING SCALE (NPRS):

    The Numeric Pain Rating Scale is a widely used, reliable, and user-friendly tool for assessing an individual's level of pain (NPRS). The patient is required to rate their level of discomfort using a self-reported scale with a range of 0 to 10, where ""0"" indicates no pain and ""10"" indicates the most excruciating pain.

    12 Months

  • PRESSURE ALGOMETRY:

    The pressure pain threshold (PPT), or the lowest force that causes pain in a particular body part, can be objectively measured using pressure algometry. To test sensitivity and identify shifts in pain perception, a portable instrument called a pressure algometer gently and gradually applies pressure to tissue, such as muscles or tendons. Pressure Algometry offers a methodical, objective way to measure pain sensitivity, which is commonly utilized in clinical and research contexts. It is frequently used to evaluate tenderness and pain in musculoskeletal issues, myofascial pain, and tendinopathy. Pressure algometry is a widely used tool to assess mechanical pain sensitivity by applying controlled pressure to a specific area and measuring the pain threshold. Its reliability is well-established, with intra-rater reliability coefficients ranging from 0.70 to 0.94, depending on the site of application and methodological consistency .

    12 Months

Study Arms (2)

Isometric Contraction-Based Pain Modulation Protocol for Achilles Tendinopathy

EXPERIMENTAL
Diagnostic Test: Isometric Contraction-Based Pain Modulation Protocol for Achilles Tendinopathy

Eccentric Strengthening (Alfredson's Protocol for Achilles Tendinopathy )

EXPERIMENTAL
Combination Product: Eccentric Strengthening (Alfredson's Protocol for Achilles Tendinopathy )

Interventions

The standard recommendation for tendinopathy rehab became 30 to 45 second heavy isometric contractions repeated for 3 to 5 repetitions

Isometric Contraction-Based Pain Modulation Protocol for Achilles Tendinopathy

The eccentric loading protocol, popularized by the research of Alfredson, consisted of 3 sets of 15 for both bent knee and straight knee heel raises with each heel lowering lasting 3-seconds

Eccentric Strengthening (Alfredson's Protocol for Achilles Tendinopathy )

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically Diagnosed with Achilles Tendinopathy using MRI
  • At least 3 months incidence period of Achilles Tendinopathy
  • Must be able to attend all treatment sessions and follow-up assessments.
  • Ability to walk independently without any assistive devices.

You may not qualify if:

  • Severely restricted ROM of ankle
  • Patients who underwent surgery for Achilles tendinopathy
  • Patients who had undergone previous surgery of lower limb extremity
  • Those using ankle orthosis
  • Patients with systemic diseases affecting ankle (osteoarthritis, rheumatoid arthritis, and osteoporosis)
  • Individuals with neurological disorders affecting the lower limbs.
  • Systemic Conditions like diabetes, cardiovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab Social Security Health Management Hospital Manga Raiwind

Lahore, Punjab Province, Pakistan

Location

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 25, 2025

First Posted

April 1, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations