Trial Outcomes & Findings for Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy (NCT NCT04725513)
NCT ID: NCT04725513
Last Updated: 2026-01-12
Results Overview
Calf raises performed to fatigue and inability to continue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Difference from 0-3 months
Results posted on
2026-01-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Photobiomodulation, Shockwave Therapy and Physical Therapy
Participants allocated to this treatment protocol completed EXER and also received a combination of RPW and PBMT
|
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.
|
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.
|
|---|---|---|---|
|
enrollment to 3 months
STARTED
|
16
|
16
|
14
|
|
enrollment to 3 months
COMPLETED
|
15
|
15
|
12
|
|
enrollment to 3 months
NOT COMPLETED
|
1
|
1
|
2
|
|
elective cross-over 3 months to 6 months
STARTED
|
11
|
8
|
14
|
|
elective cross-over 3 months to 6 months
COMPLETED
|
11
|
8
|
14
|
|
elective cross-over 3 months to 6 months
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
Baseline characteristics by cohort
| Measure |
Physical Therapy Only
n=15 Participants
|
Shockwave Therapy and Physical Therapy
n=12 Participants
|
Photobiomodulation, Shockwave Therapy and Physical Therapy
n=15 Participants
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10 • n=210 Participants
|
42 years
STANDARD_DEVIATION 13 • n=19 Participants
|
42 years
STANDARD_DEVIATION 14 • n=8 Participants
|
40 years
STANDARD_DEVIATION 13 • n=24 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
7 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
8 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=210 Participants
|
12 Participants
n=19 Participants
|
14 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Difference from 0-3 monthsCalf raises performed to fatigue and inability to continue
Outcome measures
| Measure |
Physical Therapy Only
n=15 Participants
exercise program
|
Shockwave Therapy and Physical Therapy
n=12 Participants
exercise program with three sessions of radial pressure waves
|
Photobiomodulation, Shockwave Therapy and Physical Therapy
n=15 Participants
combination of exercise program, three sessions of radial pressure waves, and 6 sessions of photobiomodulation treatment
|
|---|---|---|---|
|
Calf Raises Performed to Fatigue and Inability to Continue
|
3 Calf raises
Standard Deviation 6
|
8 Calf raises
Standard Deviation 13
|
5 Calf raises
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Difference from 0-3 monthsChanges in the cross-sectional area measured on ultrasound
Outcome measures
| Measure |
Physical Therapy Only
n=15 Participants
exercise program
|
Shockwave Therapy and Physical Therapy
n=12 Participants
exercise program with three sessions of radial pressure waves
|
Photobiomodulation, Shockwave Therapy and Physical Therapy
n=15 Participants
combination of exercise program, three sessions of radial pressure waves, and 6 sessions of photobiomodulation treatment
|
|---|---|---|---|
|
Ultrasound Measurements in Change of Cross Sectional Area
|
-0.03 cross sectional area of tendon in mm^2
Standard Deviation 0.14
|
-0.05 cross sectional area of tendon in mm^2
Standard Deviation 0.06
|
-0.03 cross sectional area of tendon in mm^2
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: change from baseline to 3 month follow-up measureVictorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).
Outcome measures
| Measure |
Physical Therapy Only
n=15 Participants
exercise program
|
Shockwave Therapy and Physical Therapy
n=12 Participants
exercise program with three sessions of radial pressure waves
|
Photobiomodulation, Shockwave Therapy and Physical Therapy
n=15 Participants
combination of exercise program, three sessions of radial pressure waves, and 6 sessions of photobiomodulation treatment
|
|---|---|---|---|
|
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
|
18 VISA-A units on a scale
Standard Deviation 17
|
33 VISA-A units on a scale
Standard Deviation 15
|
25 VISA-A units on a scale
Standard Deviation 40
|
Adverse Events
Physical Therapy Only
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Shockwave Therapy and Physical Therapy
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Photobiomodulation, Shockwave Therapy and Physical Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Physical Therapy Only
n=16 participants at risk
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.
|
Shockwave Therapy and Physical Therapy
n=14 participants at risk
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.
|
Photobiomodulation, Shockwave Therapy and Physical Therapy
n=16 participants at risk
Participants allocated to this treatment protocol completed EXER and also received a combination of RPW and PBMT
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Expected adverse event defined as pain, soreness, bruising or swelling
|
62.5%
10/16 • Number of events 13 • 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
|
71.4%
10/14 • Number of events 14 • 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
|
56.2%
9/16 • Number of events 11 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place