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Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shockwave Therapy
Photobiomodulation Therapy
Physical Therapy
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Hospital CambridgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Physical Therapy Only

Shockwave Therapy and Physical Therapy

Photobiomodulation, Shockwave Therapy and Physical Therapy

Arm Description

Outcomes

Primary Outcome Measures

Calf raises to fatigue
The number of calf raises to fatigue that the participant is able to be performed by will be recorded at different time points
Ultrasound measurements
The cross-sectional area will be measure on the ultrasound
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).

Secondary Outcome Measures

Full Information

First Posted
January 14, 2021
Last Updated
September 22, 2023
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04725513
Brief Title
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
Official Title
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The first part of the study is a randomized control trial, the second part is an elective cross over
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy Only
Arm Type
Active Comparator
Arm Title
Shockwave Therapy and Physical Therapy
Arm Type
Experimental
Arm Title
Photobiomodulation, Shockwave Therapy and Physical Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Shockwave Therapy
Intervention Description
Participants will receive shockwave therapy once a week for three weeks
Intervention Type
Device
Intervention Name(s)
Photobiomodulation Therapy
Intervention Description
Participants will receive photobiomodulation therapy twice a week for three weeks
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Participants will enroll in physical therapy and complete an at-home exercise protocol
Primary Outcome Measure Information:
Title
Calf raises to fatigue
Description
The number of calf raises to fatigue that the participant is able to be performed by will be recorded at different time points
Time Frame
0-6 months
Title
Ultrasound measurements
Description
The cross-sectional area will be measure on the ultrasound
Time Frame
0-6 months
Title
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
Description
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
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Tenforde, MD
Phone
617-952-6808
Email
atenforde@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Linh Pham
Phone
6177242168
Email
lpham9@mgh.harvard.edu
Facility Information:
Facility Name
Spaulding Hospital Cambridge
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam S Tenforde, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36187084
Citation
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.
Results Reference
derived

Learn more about this trial

Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy

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