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CompletedNCT03167710Updated Sep 5, 2023

Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia

An interventional study of Dry Needling, manipulation, stretching and manual therapy, exercise, ultrasound in Lateral Epicondylitis, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Lateral Epicondylitis

Browse trials for

03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    dry needling, manipulation stretching

    Other: Dry Needling, manipulation, stretching

  • Active comparator
    manual therapy, exercise, ultrasound

    Other: manual therapy, exercise, ultrasound

Interventions

  • OtherDry 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.

  • Othermanual 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.

05

What researchers measure

Primary outcomes

  1. Change in Elbow pain (NPRS) (Rating Score)

    Rating Score. Baseline score must exceed 2/10 to be included in the study.

    Time frame: Baseline, 1 week, 4 weeks, 3 months

  2. 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.

    Time frame: Baseline, 1 week, 4 weeks, 3 months

Secondary outcomes

  1. Change in Global Rating of Change Score

    Time frame: 1 week, 4 weeks, 3 months

  2. 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.

    Time frame: Baseline, 1 week, 4 weeks, 3 months

  3. Change in Medication Intake (Frequency of medication intake in last week)

    Time frame: Baseline, 3 months

06

Study locations

1 site
  • Evolution Sports Physiotherapy
    Cockeysville, Maryland 21030, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03167710
Lead sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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) — Principal investigator
First posted
May 30, 2017
Start date
Jun 15, 2017
Primary completion
Mar 15, 2021
Completion
Mar 15, 2021
Last update
Sep 5, 2023

Study contacts

James Dunning, DPT
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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