Back to resultsDry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling, manipulation, stretching
manual therapy, exercise, ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
Eligibility Criteria
Inclusion Criteria:
- Adult between 18 and 60 years old that is able to speak English.
- Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
- Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
Diagnosis of lateral epicondylitis, defined as two of more of the following:
- Pain on palpation over the lateral epicondyle and the associated common extensor unit
- Pain on gripping a hand dynamometer
- Pain with stretching or contraction of the wrist extensor muscles
Exclusion Criteria:
- 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.
- Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture
Report of systemic neurological disorders and/or neurological deficits to include the following:
- 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)
- Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
- 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)
- History of whiplash injury within the previous 6 weeks
- History of surgery to the head/neck or affected upper extremity.
- Psychiatric disorders or cognitively impaired
- Pregnancy
Sites / Locations
- Evolution Sports Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dry needling, manipulation stretching
manual therapy, exercise, ultrasound
Arm Description
Outcomes
Primary Outcome Measures
Change in Elbow pain (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Patient-related Tennis Elbow Questionnaire
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
Change in Global Rating of Change Score
Change in Tennis Elbow Functional Scale
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)
Full Information
NCT ID
NCT03167710
First Posted
May 24, 2017
Last Updated
September 1, 2023
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03167710
Brief Title
Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
Official Title
Electric Dry Needling, Thrust Manipulation and Stretching Versus Impairment-based Manual Therapy, Exercise and Ultrasound for Patients With Lateral Epicondylalgia: A Multi-center Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dry needling, manipulation stretching
Arm Type
Experimental
Arm Title
manual therapy, exercise, ultrasound
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dry Needling, manipulation, stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
manual therapy, exercise, ultrasound
Intervention Description
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 Measure Information:
Title
Change in Elbow pain (NPRS) (Rating Score)
Description
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Patient-related Tennis Elbow Questionnaire
Description
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.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change Score
Time Frame
1 week, 4 weeks, 3 months
Title
Change in Tennis Elbow Functional Scale
Description
The Tennis Elbow Functional Scale (TEFS) is a 0-40 that assesses disability related to lateral epicondylitis. Greater scores indicate increased disability.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Medication Intake (Frequency of medication intake in last week)
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult between 18 and 60 years old that is able to speak English.
Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
Diagnosis of lateral epicondylitis, defined as two of more of the following:
Pain on palpation over the lateral epicondyle and the associated common extensor unit
Pain on gripping a hand dynamometer
Pain with stretching or contraction of the wrist extensor muscles
Exclusion Criteria:
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.
Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture
Report of systemic neurological disorders and/or neurological deficits to include the following:
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)
Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
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)
History of whiplash injury within the previous 6 weeks
History of surgery to the head/neck or affected upper extremity.
Psychiatric disorders or cognitively impaired
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evolution Sports Physiotherapy
City
Cockeysville
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
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