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This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.
This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy Only | Active Comparator |
| |
| Shockwave Therapy and Physical Therapy | Experimental |
| |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Therapy | Device | Participants will receive shockwave therapy once a week for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calf Raises Performed to Fatigue and Inability to Continue | Calf raises performed to fatigue and inability to continue | Difference from 0-3 months |
| Ultrasound Measurements in Change of Cross Sectional Area | Changes in the cross-sectional area measured on ultrasound | Difference from 0-3 months |
| Victorian Institute of Sports Assessment (VISA-A) Questionnaire | Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better). | change from baseline to 3 month follow-up measure |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Hospital Cambridge | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41070206 | Derived | Tenforde AS, Pham L, Gaudette LW, Funk MM, Vogel KE, Bruneau MM, Yuan X, Schroeder JD, Isaacson B, Hagar N, Metzger E, Nolan DC, Tam J, Silbernagel KG. Exercise, radial pressure waves, and photobiomodulation for management of non-insertional Achilles tendinopathy in runners: a three-arm non-blinded randomised control trial. BMJ Open Sport Exerc Med. 2025 Oct 5;11(4):e002442. doi: 10.1136/bmjsem-2024-002442. eCollection 2025. | |
| 36187084 |
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After screening and obtaining written informed consent, participants who enrolled were assigned, using block randomisation design, o one of three conditions: EXER; EXER and RPW; or EXER, RPW and PBMT.
After 3 months, participants could elect to participate for three additional months using a different treatment than initially prescribed (EXER +RPW or EXER + RPW + PBMT) or could continue EXER and complete a 6-month follow-up visit.
Target enrollment was 60 participants randomly assigned equally to three groups. No power calculations were used to determine sample size as no comparable studies were identified to estimate effects of RPW. Eligible participants were runners aged 18-65 with primary running-related injury diagnosed as unilateral or bilateral non-insertional AT and symptoms exceeding 3 months. Each reported running as their primary sport, with weekly volume >16 km.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Therapy Only | Participants were all prescribed a four-phase progressive Achilles tendon-loading program. Twice weekly calls were completed over 3 weeks to ensure compliance and answer questions. In addition to the Achilles loading program, each participant was instructed to continue exercises prescribed by their physical therapist to address individual impairments contributing to injury. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| enrollment to 3 months |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 |
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The first part of the study is a randomized control trial, the second part is an elective cross over
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| Photobiomodulation Therapy | Device | Participants will receive photobiomodulation therapy twice a week for three weeks |
|
| Physical Therapy | Other | Participants will enroll in physical therapy and complete an at-home exercise protocol |
|
| Derived |
| Tenforde AS, Vogel KEL, Tam J, Silbernagel KG. Research protocol to evaluate the effectiveness of shockwave therapy, photobiomodulation and physical therapy in the management of non-insertional Achilles tendinopathy in runners: a randomised control trial with elective cross-over design. BMJ Open Sport Exerc Med. 2022 Sep 27;8(3):e001397. doi: 10.1136/bmjsem-2022-001397. eCollection 2022. |
| FG001 | Shockwave Therapy and Physical Therapy | Participants in this treatment arm completed the same loading protocol as EXER and also received RPW delivered once per week for 3 weeks with a telephone check-in later in the week. |
| FG002 | Photobiomodulation, Shockwave Therapy and Physical Therapy | Participants allocated to this treatment protocol completed EXER and also received a combination of RPW and PBMT |
| COMPLETED |
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| NOT COMPLETED |
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| elective cross-over 3 months to 6 months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Therapy Only | |
| BG001 | Shockwave Therapy and Physical Therapy | |
| BG002 | Photobiomodulation, Shockwave Therapy and Physical Therapy | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age at enrollment | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Calf Raises Performed to Fatigue and Inability to Continue | Calf raises performed to fatigue and inability to continue | Posted | Mean | Standard Deviation | Calf raises | Difference from 0-3 months |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Ultrasound Measurements in Change of Cross Sectional Area | Changes in the cross-sectional area measured on ultrasound | Posted | Mean | Standard Deviation | cross sectional area of tendon in mm^2 | Difference from 0-3 months |
|
| |||||||||||||||||||||||||||||||||
| Primary | Victorian Institute of Sports Assessment (VISA-A) Questionnaire | Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better). | Posted | Mean | Standard Deviation | VISA-A units on a scale | change from baseline to 3 month follow-up measure |
|
3 months
Both expected and unexpected changes in health were recorded as adverse events and were obtain after each treatment and at each follow-up timepoint
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Therapy Only | Participants were all prescribed a four-phase progressive Achilles tendon-loading program. Twice weekly calls were completed over 3 weeks to ensure compliance and answer questions. In addition to the Achilles loading program, each participant was instructed to continue exercises prescribed by their physical therapist to address individual impairments contributing to injury. | 0 | 16 | 0 | 16 | 10 | 16 |
| EG001 | Shockwave Therapy and Physical Therapy | Participants in this treatment arm completed the same loading protocol as EXER and also received RPW delivered once per week for 3 weeks with a telephone check-in later in the week. | 0 | 14 | 0 | 14 | 10 | 14 |
| EG002 | Photobiomodulation, Shockwave Therapy and Physical Therapy | Participants allocated to this treatment protocol completed EXER and also received a combination of RPW and PBMT | 0 | 16 | 0 | 16 | 9 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Expected adverse event defined as pain, soreness, bruising or swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | all were reported as mild to moderate, these were obtained from baseline to 3 months of the initial intervention study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Tenforde, MD | Spaulding Rehabilitation Hospital | 6179526800 | atenforde@mgh.harvard.edu |
| Nov 22, 2025 |
| Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2024 | Oct 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D028022 | Low-Level Light Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D053685 | Laser Therapy |
| D010789 | Phototherapy |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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