Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
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|ClinicalTrials.gov Identifier: NCT03167710|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis||Other: Dry Needling, manipulation, stretching Other: manual therapy, exercise, ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Electric Dry Needling, Thrust Manipulation and Stretching Versus Impairment-based Manual Therapy, Exercise and Ultrasound for Patients With Lateral Epicondylitis: A Multi-center Randomized Control Trial|
|Actual Study Start Date :||March 15, 2017|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2019|
|Experimental: dry needling, manipulation stretching||
Other: Dry Needling, manipulation, stretching
HVLA thrust manipulation to elbow, wrist and spine (C5-C6). Dry needling to wrist extensor muscles on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.
|Active Comparator: manual therapy, exercise, ultrasound||
Other: manual therapy, exercise, ultrasound
Impairment-based manual therapy, exercise and ultrasound targeting the wrist extensors on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.
- Change in Elbow pain (NPRS) (Rating Score) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]Rating Score. Baseline score must exceed 2/10 to be included in the study.
- Change in Patient-related Tennis Elbow Questionnaire [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]The pain, disability-specific activities and disability common activities section of the PRTEE are collectively measured on a 0-150 point scale. Greater scores indicate increased disability. Baseline must exceed 10/50 on the pain section, 10/60 on the specific activities section and 10/40 on the common activities to be included in the study.
- Change in Global Rating of Change Score [ Time Frame: 1 week, 4 weeks, 3 months ]
- Change in Tennis Elbow Functional Scale [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]The Tennis Elbow Functional Scale (TEFS) is a 0-40 that assesses disability related to lateral epicondylitis. Greater scores indicate increased disability.
- Change in Medication Intake (Frequency of medication intake in last week) [ Time Frame: Baseline, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167710
|Contact: James Dunning, DPTfirstname.lastname@example.org|
|Contact: Raymond Butts, DPT PhDemail@example.com|
|United States, Maryland|
|Evolution Sports Physiotherapy||Recruiting|
|Cockeysville, Maryland, United States, 21030|
|Contact: Morgan Johnson, DPT 410-628-0520 firstname.lastname@example.org|
|Principal Investigator:||James Dunning, DPT||American Academy of Manipulative Therapy|