Achilles TendinopathyNCT06986759
Comparative Effects of Laser and Extracorpeal Shock Wave in Patients With Achilles Tendinopathy.
A study testing Laser and Extracorporeal shock wave therapy protocol in people with Achilles Tendinopathy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Laser and Extracorporeal shock wave therapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jul 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Integrated Medical Care Hospital
Lahore, Punjab Province, 54910
Izzat Hussain, PHD scholar, 03216290232, izzatrana208@gmail.com
About this study
Official title: Comparative Effects of Laser and Extracorpeal Shock Wave Therapy on Pain, Range of Motion and Function 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.
Read the 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
- Being tested
- Laser, Extracorporeal shock wave therapy protocol
- Keywords
- Pain, Function, Range of Motion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: 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. Receives: Other: Extracorporeal shock wave therapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Foot and ankle outcome
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start24 Jul 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muzna Munir, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986759
- Sponsor's protocol ID
- REC/RCR & AHS/24/0173
- Status last verified
- Jul 2025
- First submitted
- 15 May 2025
- Last updated
- 7 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31031150Li 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.
PubMed 27885357Fares 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.
PubMed 33039245von 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.
PubMed 34099611Wang 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.
PubMed 36090915Silbernagel 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.
PubMed 32267723Xergia 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.
PubMed 35670156van 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.
PubMed 32522732Zhi 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.
PubMed 33785026Brock-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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Laser and Extracorpeal Shock Wave Therapy on Pain, Range of Motion and Function in Patients With Achilles Tendinopathy.
- ClinicalTrials.gov ID
- NCT06986759
- Acronym / sponsor ID
- REC/RCR & AHS/24/0173
- Conditions
- Achilles Tendinopathy
- Keywords
- Pain, Function, Range of Motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Jul 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser therapy protocol. | Active comparator | Other: LaserThe 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. . |
| Extracorporeal shock wave therapy protocol. | Active comparator | Other: Extracorporeal shock wave therapy protocolWhen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserThe 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. | Other | Laser therapy protocol. |
| Extracorporeal shock wave therapy protocolWhen 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. |
Primary outcome
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.
1 secondary outcome
Foot and ankle outcome
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2025.
- Background: PubMed 31031150Maffulli 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.
- Background: PubMed 27885357Li 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.
- Background: PubMed 33039245Fares 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.
- Background: PubMed 34099611von 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.
- Background: PubMed 36090915Wang 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.
- Background: PubMed 32267723Silbernagel 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.
- Background: PubMed 35670156Xergia 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.
- Background: PubMed 32522732van 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.
- Background: PubMed 33785026Zhi 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.
- BackgroundBrock-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muzna Munir, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Extracorporeal shock wave therapy protocol in people with Achilles Tendinopathy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umnah Ahmed, MS student (03345177332, umnahuart@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986759, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2025.