Comparative Effects of Laser and Extracorpeal Shock Wave in Patients With Achilles Tendinopathy.

NCT06986759 | Not Yet Recruiting

• 1 other identifier: REC/RCR & AHS/24/0173
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Achilles tendinopathy is a prevalent condition characterized by pain, swelling, and impaired function of the Achilles tendon, commonly affecting athletes and active individuals. The disorder arises from a failed healing response, leading to degenerative changes in the tendon without significant inflammation. It is categorized into insertional (at the calcaneus-Achilles junction) and non-insertional (2-6 cm proximal to the insertion) types. Intrinsic risk factors include biomechanical abnormalities and systemic conditions like diabetes and hypertension, while extrinsic factors involve excessive mechanical load and training errors. Effective management of Achilles tendinopathy is crucial for preventing long-term disability and ensuring the continuation of physical activities.

Conditions

Achilles Tendinopathy

Keywords

Pain; Function; Range of Motion

Outcome Measures

Primary Outcomes (1)

• Numeric pain rating scale

  The pain NPRS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. It has been shown that NPRS is valid, reliable and interval scale. NPRS has high test-retest reliability of ICC 0.98.

  4 weeks

Secondary Outcomes (1)

• Foot and ankle outcome

  4 weeks

Other Outcomes (1)

• Goniometer for range of motion

  4 weeks

Study Arms (2)

Laser therapy protocol.

ACTIVE COMPARATOR

The therapy system will be used the Thor DD Laser Therapy Unit. This will be a class 3B laser with an 810-nm, 100-mW infrared probe. Laser or placebo laser treatment protocols will be identical and will be delivered with the patients lying prone, with their foot over the end of the treatment plinth and the ankle plantar-grade. The contact method will be used to apply the laser treatment probe to 3 standardized points on both sides of the Achilles' tendon (6 in all: at the site of the lesion, 2cm proximal, and 2cm distal) for 30 seconds, giving a dose of 3J per point and 18J per session for the active probe. .

Other: Laser

Extracorporeal shock wave therapy protocol.

ACTIVE COMPARATOR

When treating Achilles tendinopathy, most researchers will be used 3 sessions of extracorporeal shock wave therapy (ESWT) with a one-week break in between. There will also be shorter breaks of 3 to 4 days or longer 2-week breaks. The number of pulses per session will range from 800 to 3000, and the pulse frequency will be between 4 and 50 Hz.

Other: Extracorporeal shock wave therapy protocol

Interventions

Laser OTHER

The therapy system will be used the Thor DD Laser Therapy Unit. This will be a class 3B laser with an 810-nm, 100-mW infrared probe. Laser or placebo laser treatment protocols will be identical and will be delivered with the patients lying prone, with their foot over the end of the treatment plinth and the ankle plantar-grade. The contact method will be used to apply the laser treatment probe to 3 standardized points on both sides of the Achilles' tendon (6 in all: at the site of the lesion, 2cm proximal, and 2cm distal) for 30 seconds, giving a dose of 3J per point and 18J per session for the active probe(23). The treating physiotherapist, without any knowledge of which position on the switch will be the active laser, will select position 1 or 2 on the switch according to group allocation.

Laser therapy protocol.

Extracorporeal shock wave therapy protocol OTHER

When treating Achilles tendinopathy, most researchers will be used 3 sessions of extracorporeal shock wave therapy (ESWT) with a one-week break in between. There will also be shorter breaks of 3 to 4 days or longer 2-week breaks. The number of pulses per session will range from 800 to 3000, and the pulse frequency will be between 4 and 50 Hz.

Extracorporeal shock wave therapy protocol.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of patients 18-40.
• Diagnosed with chronic Achillis tendinopathy and NPRS rating more than 2.
• Both male and female.
• Patient must be diagnosed with Achillis Tendinopathy by single leg raise or Thompson test.

You may not qualify if:

• contraindications to LLLT to the area of the Achilles tendon.
• comorbid musculoskeletal or serious conditions that may have confounded treatment or anticipated recovery .
• nonsteroidal anti-inflammatory drug use steroid injections or surgery for the condition; insertional tendinopathy or bursitis (retrocalcaneal or Achilles; determined by clinical examination.
• neurologic signs; and adverse neural tension affecting the sciatic or sural nerve.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Integrated Medical Care Hospital

Lahore, Punjab Province, 54910, Pakistan

Location

Related Publications (10)

• Maffulli N, Longo UG, Kadakia A, Spiezia F. Achilles tendinopathy. Foot Ankle Surg. 2020 Apr;26(3):240-249. doi: 10.1016/j.fas.2019.03.009. Epub 2019 Apr 18.

  PMID: 31031150 BACKGROUND

• Li HY, Hua YH. Achilles Tendinopathy: Current Concepts about the Basic Science and Clinical Treatments. Biomed Res Int. 2016;2016:6492597. doi: 10.1155/2016/6492597. Epub 2016 Nov 3.

  PMID: 27885357 BACKGROUND

• Fares MY, Khachfe HH, Salhab HA, Zbib J, Fares Y, Fares J. Achilles tendinopathy: Exploring injury characteristics and current treatment modalities. Foot (Edinb). 2021 Mar;46:101715. doi: 10.1016/j.foot.2020.101715. Epub 2020 Jul 6.

  PMID: 33039245 BACKGROUND

• von Rickenbach KJ, Borgstrom H, Tenforde A, Borg-Stein J, McInnis KC. Achilles Tendinopathy: Evaluation, Rehabilitation, and Prevention. Curr Sports Med Rep. 2021 Jun 1;20(6):327-334. doi: 10.1249/JSR.0000000000000855.

  PMID: 34099611 BACKGROUND

• Wang Y, Zhou H, Nie Z, Cui S. Prevalence of Achilles tendinopathy in physical exercise: A systematic review and meta-analysis. Sports Med Health Sci. 2022 Mar 28;4(3):152-159. doi: 10.1016/j.smhs.2022.03.003. eCollection 2022 Sep.

  PMID: 36090915 BACKGROUND

• Silbernagel KG, Hanlon S, Sprague A. Current Clinical Concepts: Conservative Management of Achilles Tendinopathy. J Athl Train. 2020 May;55(5):438-447. doi: 10.4085/1062-6050-356-19. Epub 2020 Apr 8.

  PMID: 32267723 BACKGROUND

• Xergia SA, Tsarbou C, Liveris NI, Hadjithoma Mu, Tzanetakou IP. Risk factors for Achilles tendon rupture: an updated systematic review. Phys Sportsmed. 2023 Dec;51(6):506-516. doi: 10.1080/00913847.2022.2085505. Epub 2022 Jun 10.

  PMID: 35670156 BACKGROUND

• van der Vlist AC, Winters M, Weir A, Ardern CL, Welton NJ, Caldwell DM, Verhaar JAN, de Vos RJ. Which treatment is most effective for patients with Achilles tendinopathy? A living systematic review with network meta-analysis of 29 randomised controlled trials. Br J Sports Med. 2021 Mar;55(5):249-256. doi: 10.1136/bjsports-2019-101872. Epub 2020 Jun 10.

  PMID: 32522732 BACKGROUND

• Zhi X, Liu X, Han J, Xiang Y, Wu H, Wei S, Xu F. Nonoperative treatment of insertional Achilles tendinopathy: a systematic review. J Orthop Surg Res. 2021 Mar 30;16(1):233. doi: 10.1186/s13018-021-02370-0.

  PMID: 33785026 BACKGROUND

• Brock-Jones K. The Effects of Low-Level Laser Therapy Versus Platelet Rich Plasma Therapy on Pain and Function in Patients with Achilles Tendinopathy: A Meta-Analysis: California State University, Fresno; 2023.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Muzna Munir, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umnah Ahmed, MS student

CONTACT

03345177332; umnahuart@gmail.com

Muzna Munir, PHD scholar

CONTACT

03344265125; muznafmh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: July 24, 2025
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: July 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)