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

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04725513
Collaborator
(none)
60
3
18

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Shockwave Therapy
  • Device: Photobiomodulation Therapy
  • Other: Physical Therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The first part of the study is a randomized control trial, the second part is an elective cross overThe first part of the study is a randomized control trial, the second part is an elective cross over
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Physical Therapy Only

Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol

Experimental: Shockwave Therapy and Physical Therapy

Device: Shockwave Therapy
Participants will receive shockwave therapy once a week for three weeks

Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol

Experimental: Photobiomodulation, Shockwave Therapy and Physical Therapy

Device: Shockwave Therapy
Participants will receive shockwave therapy once a week for three weeks

Device: Photobiomodulation Therapy
Participants will receive photobiomodulation therapy twice a week for three weeks

Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol

Outcome Measures

Primary Outcome Measures

  1. Calf raises to fatigue [0-6 months]

    The number of calf raises to fatigue that the participant is able to be performed by will be recorded at different time points

  2. Ultrasound measurements [0-6 months]

    The cross-sectional area will be measure on the ultrasound

  3. Victorian Institute of Sports Assessment (VISA-A) Questionnaire [0-6 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Spaulding Rehabilitation Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adam Tenforde, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT04725513
Other Study ID Numbers:
  • 2021P000025
First Posted:
Jan 26, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022