Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607356
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2020-10-13
Brief Title:
Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BFR
Brief Summary:
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia tennis elbow
Detailed Description:
Background Lateral Epicondylalgia or tennis elbow has been shown to affect up to 3 of the population and is a common musculoskeletal condition which also affects military service members This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain
Design Prospective randomized controlled clinical trial
Methods Participants between the ages of 18-65 presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either 1 a standardized evidence based rehabilitation program or 2 an exercise volume matched group using personalized blood flow restriction BFR exercise
Upon entry to the program subjects will complete measurements of height body weight physical activity level Marx Activity Scale annotation of their dominant upper extremity UE the patient-rated tennis elbow evaluation PRTEE questionnaire Numerical Pain Rating Scale NPRS Patient-Reported Outcome Measurement Information System version 12- Global Health PROMIS scale v12- Global Health and grip strength using the JAMAR dynamometer At the end of each treatment session subjects will complete the Numerical Pain Rating Scale NPRS and the OMNI-Resistance Exercise Scale OMNI-RES rating of perceived exertion RPE survey
The standard rehabilitation group will perform active wrist extension forearm supination and gripping These exercises may include isometric concentric or eccentric forms of strengthening contingent upon clinical decision making Specifics of exercise performance to include magnitude of resistance and volume of exercise will be documented in the treatment record
The Delphi Personalized Tourniquet System PTS will be utilized for the BFR exercises The Delphi PTS measures an individuals personalized tourniquet pressure PTP using doppler technology similar to a blood pressure cuff In the BFR exercise condition subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist
Participants will be provided in-clinic treatment for a maximum of 12 sessions one to three treatment sessions weekly and may be discharged prior to that based upon shared decision making between the participant and therapist The NPRS grip strength PROMIS scale v12- Global Health and PRTEE will be completed at the last clinical appointment as well as three and six-week and three and six month follow up appointments Twelve months following completion of occupationalphysical therapy clinical care participants will be contacted and asked to complete a verbal NPRS PROMIS scale v12- Global Health and the PRTEE outcome scale Additionally at 12 months following discharge from Physical or Occupational Therapy the participants EMR will be reviewed for follow-up visits related to the same condition LET
Data Analysis A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures grip strength NPRS and PRTEE between the time points of intake end of occupationalphysical therapy treatment and three and six months post completion of treatment Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model Healthcare providers will be analyzed as a co-variate Microsoft Excel and SPSS will function as the main data analysis instruments
Clinical Implications Results of this study are expected to guide clinicians selection of rehabilitation techniques to improve outcomes increase strength improve function and decrease pain improve mission readiness by earlier return to duty reduce healthcare service costs and also reduce lost dutywork time
Design Prospective randomized controlled clinical trial
Methods Participants between the ages of 18-65 presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either 1 a standardized evidence based rehabilitation program or 2 an exercise volume matched group using personalized blood flow restriction BFR exercise
Upon entry to the program subjects will complete measurements of height body weight physical activity level Marx Activity Scale annotation of their dominant upper extremity UE the patient-rated tennis elbow evaluation PRTEE questionnaire Numerical Pain Rating Scale NPRS Patient-Reported Outcome Measurement Information System version 12- Global Health PROMIS scale v12- Global Health and grip strength using the JAMAR dynamometer At the end of each treatment session subjects will complete the Numerical Pain Rating Scale NPRS and the OMNI-Resistance Exercise Scale OMNI-RES rating of perceived exertion RPE survey
The standard rehabilitation group will perform active wrist extension forearm supination and gripping These exercises may include isometric concentric or eccentric forms of strengthening contingent upon clinical decision making Specifics of exercise performance to include magnitude of resistance and volume of exercise will be documented in the treatment record
The Delphi Personalized Tourniquet System PTS will be utilized for the BFR exercises The Delphi PTS measures an individuals personalized tourniquet pressure PTP using doppler technology similar to a blood pressure cuff In the BFR exercise condition subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist
Participants will be provided in-clinic treatment for a maximum of 12 sessions one to three treatment sessions weekly and may be discharged prior to that based upon shared decision making between the participant and therapist The NPRS grip strength PROMIS scale v12- Global Health and PRTEE will be completed at the last clinical appointment as well as three and six-week and three and six month follow up appointments Twelve months following completion of occupationalphysical therapy clinical care participants will be contacted and asked to complete a verbal NPRS PROMIS scale v12- Global Health and the PRTEE outcome scale Additionally at 12 months following discharge from Physical or Occupational Therapy the participants EMR will be reviewed for follow-up visits related to the same condition LET
Data Analysis A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures grip strength NPRS and PRTEE between the time points of intake end of occupationalphysical therapy treatment and three and six months post completion of treatment Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model Healthcare providers will be analyzed as a co-variate Microsoft Excel and SPSS will function as the main data analysis instruments
Clinical Implications Results of this study are expected to guide clinicians selection of rehabilitation techniques to improve outcomes increase strength improve function and decrease pain improve mission readiness by earlier return to duty reduce healthcare service costs and also reduce lost dutywork time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None