Achilles Tendinopathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEShockwave Therapy
Participants will receive shockwave therapy once a week for three weeks
DEVICEPhotobiomodulation Therapy
Participants will receive photobiomodulation therapy twice a week for three weeks
OTHERPhysical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The first part of the study is a randomized control trial, the second part is an elective cross over
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral) * Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running * VISA-A \<80 at baseline to be eligible
Exclusion criteria
* Less than 3 months of symptoms * Primary insertional Achilles tendinopathy * Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT * Have received SWT within the past 3 months to their Achilles * Prior injection within 3 months * Currently enrolled in PT for more than 4 weeks for their condition * Women who are pregnant. * known history of Achilles tendon tear * currently taking oral steroid or fluoroquinolone class of antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calf Raises Performed to Fatigue and Inability to Continue | Difference from 0-3 months | Calf raises performed to fatigue and inability to continue |
| Ultrasound Measurements in Change of Cross Sectional Area | Difference from 0-3 months | Changes in the cross-sectional area measured on ultrasound |
| Victorian Institute of Sports Assessment (VISA-A) Questionnaire | change from baseline to 3 month follow-up measure | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Physical Therapy Only | 15 |
| Shockwave Therapy and Physical Therapy | 12 |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | 15 |
| Total | 42 |
Baseline characteristics
| Characteristic | Physical Therapy Only | Shockwave Therapy and Physical Therapy | Photobiomodulation, Shockwave Therapy and Physical Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 10 | 42 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 14 | 40 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 12 Participants | 14 Participants | 38 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 10 / 16 | 10 / 14 | 9 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 | 0 / 16 |
Outcome results
Primary
Calf Raises Performed to Fatigue and Inability to Continue
Calf raises performed to fatigue and inability to continue
Time frame: Difference from 0-3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy Only | Calf Raises Performed to Fatigue and Inability to Continue | 3 Calf raises | Standard Deviation 6 |
| Shockwave Therapy and Physical Therapy | Calf Raises Performed to Fatigue and Inability to Continue | 8 Calf raises | Standard Deviation 13 |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Calf Raises Performed to Fatigue and Inability to Continue | 5 Calf raises | Standard Deviation 11 |
Primary
Ultrasound Measurements in Change of Cross Sectional Area
Changes in the cross-sectional area measured on ultrasound
Time frame: Difference from 0-3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy Only | Ultrasound Measurements in Change of Cross Sectional Area | -0.03 cross sectional area of tendon in mm^2 | Standard Deviation 0.14 |
| Shockwave Therapy and Physical Therapy | Ultrasound Measurements in Change of Cross Sectional Area | -0.05 cross sectional area of tendon in mm^2 | Standard Deviation 0.06 |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Ultrasound Measurements in Change of Cross Sectional Area | -0.03 cross sectional area of tendon in mm^2 | Standard Deviation 0.15 |
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).
Time frame: change from baseline to 3 month follow-up measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Therapy Only | Victorian Institute of Sports Assessment (VISA-A) Questionnaire | 18 VISA-A units on a scale | Standard Deviation 17 |
| Shockwave Therapy and Physical Therapy | Victorian Institute of Sports Assessment (VISA-A) Questionnaire | 33 VISA-A units on a scale | Standard Deviation 15 |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Victorian Institute of Sports Assessment (VISA-A) Questionnaire | 25 VISA-A units on a scale | Standard Deviation 40 |