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

NCT ID: NCT06986759

Last Updated: 2025-07-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2025-10-20

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.

Detailed Description

This study is a randomized clinical trial aimed at comparing the effectiveness of laser therapy and extracorporeal shock wave therapy on pain, range of motion, and function in patients with Achilles tendinopathy. The trial will be conducted at Hameed Latif Hospital, Lahore, Punjab, over a duration of nine months. A total of 44 participants, aged 18-40, diagnosed with Achilles tendinopathy and meeting specific inclusion criteria, will be randomly allocated into two groups using a lottery method. Group A will receive laser therapy, and Group B will undergo extracorporeal shock wave. Baseline and post-treatment measurements will be taken using the Visual Analogue Scale , Foot and Ankle Outcome Score , and goniometric measurements for range of motion. The data will be analyzed using SPSS software to evaluate the effectiveness of each treatment modality. For Group A, laser therapy will be administered using the Laser Therapy Unit, a class 3B laser with an 810-nm, 100-milliwatt infrared probe. The treatment will be applied to six standardized points around the Achilles tendon for 30 seconds each, providing a total dose of 18 joule per session. Group B will receive extracorporeal shock wave with each session involving 1500-3000 pulses at a frequency of 1-4 Hertz. Treatments will be conducted once a week for three weeks, with a one-week break between sessions. Both therapies aim to reduce pain and improve function by enhancing the healing processes of the damaged tendon.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser therapy protocol.

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. .

Group Type: ACTIVE_COMPARATOR

Laser

Intervention Type: 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.

Extracorporeal shock wave therapy protocol.

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal shock wave therapy protocol

Intervention Type: 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.

Interventions

Laser

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.

Intervention Type: OTHER

Extracorporeal shock wave therapy protocol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muzna Munir, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Integrated Medical Care Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Umnah Ahmed, MS student

Role: CONTACT

umnahuart@gmail.com

03345177332

Muzna Munir, PHD scholar

Role: CONTACT

muznafmh@gmail.com

03344265125

Facility Contacts

Izzat Hussain, PHD scholar

Role: primary

izzatrana208@gmail.com

03216290232

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

Other Identifiers

REC/RCR & AHS/24/0173

Identifier Type: -

Identifier Source: org_study_id