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NCT Number: NCT06986759

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

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.

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Key information

Conditions

Achilles Tendinopathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrated Medical Care Hospital

Lahore, Punjab Province, 54910, Pakistan

Location contact

Izzat Hussain, PHD scholar

CONTACT

[email protected]

03216290232

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Numeric pain rating scale

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Foot and ankle outcome

    Time frame: 4 weeks

    The FAOS is a patient-reported foot- and ankle-specific questionnaire including 42 items in 5 subscales evaluating pain, symptoms, function of daily living (ADL), function in sport and recreation (sport/rec), and quality of life (QOL). The outcome of FAOS is calculated based on a standardized scoring algorithm given a score between 0 and 100 for each of the 5 subscales. A score of 100 indicates the best possible results and 0 the worst outcome. Test-retest reliability shows intraclass correlation coefficient (95% confidence interval) was calculated as 0.94 (0.89-0.96

Other outcomes

  1. Goniometer for range of motion

    Time frame: 4 weeks

    Goniometers are traditionally used to determine ROM of the ankle joint. Goniometers are considered valid and reliable clinical tools for assessing range of motion of joints of the extremities. A typical goniometric measurement of the ankle is made with the patient's leg supine on the treatment table and the fulcrum at the lateral malleolus whilst maintaining the bottom rod of the goniometer parallel with the tibia and fibula. the intraclass correlation coefficient (ICC) of ankle angle values were (dorsiflexion = 0.96), (plantarflexion = 0.81), (inversion = 0.92), (eversion = 0.95), (internal rotation = 0.92), and (external rotation = 0.78).

Study contacts

Contact information is provided by the study sponsor or research team.

Muzna Munir, PHD scholar

CONTACT

[email protected]

03344265125

Umnah Ahmed, MS student

CONTACT

[email protected]

03345177332

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Laser and Extracorpeal Shock Wave Therapy on Pain, Range of Motion and Function in Patients With Achilles Tendinopathy.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Jul 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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