Clinical trial NCT03167710: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2017-05-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Change in Elbow pain (NPRS) (Rating Score)
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Patient-related Tennis Elbow Questionnaire
timeFrame: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes:
measure: Change in Global Rating of Change Score
timeFrame: 1 week, 4 weeks, 3 months
measure: Change in Tennis Elbow Functional Scale
timeFrame: Baseline, 1 week, 4 weeks, 3 months
measure: Change in Medication Intake (Frequency of medication intake in last week)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Cockeysville
country: United States
facility: Evolution Sports Physiotherapy
state: Maryland
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT
role: PRINCIPAL_INVESTIGATOR
References: