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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
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Brief Summary:
The purpose of this research is to compare two different approaches for treating patients with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use all of these techniques to treat lateral epicondyalgia. This study is attempting to find out if one treatment strategy is more effective than the other.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Other: Dry Needling, manipulation, stretching Other: manual therapy, exercise, ultrasound Not Applicable

Detailed Description:
Patients with epicondyalgia will be randomized to receive 2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) electric dry needling, thrust manipulation and stretching or (2) impairment-based manual therapy, exercise and ultrasound

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in Global Rating of Change Score [ Time Frame: 1 week, 4 weeks, 3 months ]
  2. 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.

  3. Change in Medication Intake (Frequency of medication intake in last week) [ Time Frame: Baseline, 3 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult between 18 and 60 years old that is able to speak English.
  2. Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
  3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
  4. Diagnosis of lateral epicondylitis, defined as two of more of the following:

    1. Pain on palpation over the lateral epicondyle and the associated common extensor unit
    2. Pain on gripping a hand dynamometer
    3. Pain with stretching or contraction of the wrist extensor muscles

Exclusion Criteria:

  1. Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
  2. Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture
  3. Report of systemic neurological disorders and/or neurological deficits to include the following:

    1. Nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome)
    2. Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
    3. Central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes)
    4. History of whiplash injury within the previous 6 weeks
  4. History of surgery to the head/neck or affected upper extremity.
  5. Psychiatric disorders or cognitively impaired
  6. Pregnancy

Information from the National Library of Medicine

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


Contacts
Contact: James Dunning, DPT 801-707-9056 jamesdunning@hotmail.com
Contact: Raymond Butts, DPT PhD 803-422-3954 fellowship@spinalmanipulation.org

Locations
United States, Maryland
Evolution Sports Physiotherapy Recruiting
Cockeysville, Maryland, United States, 21030
Contact: Morgan Johnson, DPT    410-628-0520    morgan@evolutionsportspt.com   
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
Principal Investigator: James Dunning, DPT American Academy of Manipulative Therapy

Responsible Party: James Dunning, DPT, MSc, FAAOMPT, Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT03167710     History of Changes
Other Study ID Numbers: AAMT0010
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries