NCT06905756

Brief Summary

A common overuse injury to the Achilles tendon, Achilles tendinopathy frequently causes pain, restricted range of motion, and functional impairment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 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)

  • Numerical pain rating scale

    The Pain Scale has a numerical rating system (NRS) with 11 points, with 0 denoting no pain and 10 denoting the most excruciating pain. The following categories apply to scores: 0= denotes no pain 1-3= mild pain 4-6=moderate pain 7-10= severe pain.(12)

    12 Months

  • WHOQOL (world health organization and quality of life)

    The WHOQOL uses 26 questions to calculate quality of life across the four domains. Each item is scored on a 5-point Likert scale (1 to 5), where higher scores indicate a better quality of life, lower score indicate, poor quality of life. Average total score for healthy populations is about 90. 0-20 = Poor Quality of Life 21-40 = Moderate Quality of Life 41-60 = Good Quality of Life 61-80 or greater than 80 = Very Good Quality of life.

    12 Months

Study Arms (2)

Accelerated rehabilitation

EXPERIMENTAL
Diagnostic Test: Accelerated rehabilitation

Eccentric strengthening exercises

EXPERIMENTAL
Combination Product: Eccentric strengthening exercises

Interventions

15 subjects in group A will be receiving Accelerated Rehabilitation protocol alongwith baseline treatment. Accelerated rehabilitation consisting of three phases, following 12 week exercise regime. Pain reduction, mobility, strengthening, and functional recovery are part of the accelerated rehabilitation protocol for Achilles tendinopathy. Ice, TENS, range-of-motion exercises, isometric calf contractions, and a progressive transition to full weight-bearing based are the mainstays of Phase 1 (Weeks 1-4). Phase 2 (Weeks 5-8) focuses on balance training, resistance band exercises, and seated and standing calf raises as well as light functional workouts like cycling or walking. Phase 3 (Weeks 9-12) progresses to sport-specific and endurance exercises like swimming or running after including plyometric drills, eccentric heel drops, and advanced strengthening. Each exercise will be performed under supervision of skilled physiotherapist for 2 times daily, 2 sets of 5 repetitions.

Accelerated rehabilitation

Group B will be receiving eccentric strengthening exercises alongwith baseline treatment. Techniques of Curwin, Stanish et al will be used for eccentric training. For every exercise, participants do three sets of 15 repetitions, with a 30-second break in between. Weight is added gradually to enhance resistance (5-10 lbs or more, depending on tolerance). The eccentric strengthening regimen for Achilles tendinopathy advances every week. Participants use both feet without dorsiflexion to perform eccentric contractions in Week 1. By Week 3, the focus of the workouts is on the injured foot in maximum dorsiflexion. In Week 4, 10% body weight resistance is introduced, and in Week 5, an extra 5-10 pounds. From Week 6 to Week 8, resistance rises every two weeks. From Weeks 9 to 12, functional motions like hopping, single-leg heel drops, and sport-specific drills are incorporated, all of which are customized to meet individual goals.

Eccentric strengthening exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients, age greater than 18 years, clinically diagnosed with Achilles tendinopathy.
  • Participants that are clinically diagnosed with Achilles tendinopathy.
  • Duration of symptoms or pain for more than 1 month.
  • Positive clinical tests, such as Thompson test, confirming Achilles tendinopathy.
  • Tenderness to palpation along the Achilles tendon or localized pain during activity.
  • Patients with a history of overuse injuries related to repetitive activities, such as running or jumping.

You may not qualify if:

  • Following participants will be excluded from this study:
  • Presence of systemic conditions such as rheumatoid arthritis, diabetes, or other inflammatory or neuromuscular disorders.
  • History of complete Achilles tendon rupture or previous surgical intervention on the affected tendon.
  • Patients with other lower limb injuries or conditions (e.g., fractures, ligament tears) that could interfere with Achilles tendinopathy treatment.
  • Severe tendon degeneration or calcification confirmed by imaging, unsuitable for rehabilitation.

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
DIAGNOSTIC
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