Lateral EpicondylitisNCT03167710
Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
A study testing Dry Needling, manipulation, stretching and manual therapy, exercise, ultrasound in people with Lateral Epicondylitis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Dry Needling, manipulation, stretching and manual therapy, exercise, ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Evolution Sports Physiotherapy
Cockeysville, Maryland, 21030
About this study
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
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
- Conditions
- Lateral Epicondylitis
- Being tested
- Dry Needling, manipulation, stretching, manual therapy, exercise, ultrasound
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling, manipulation, stretchingOther
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.
manual therapy, exercise, ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dry needling, manipulation stretching | Experimental | Not described Receives: Other: Dry Needling, manipulation, stretching |
| manual therapy, exercise, ultrasound | Active comparator | Not described Receives: Other: manual therapy, exercise, ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Elbow pain (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Measured: Baseline, 1 week, 4 weeks, 3 months
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.
Measured: Baseline, 1 week, 4 weeks, 3 months
Secondary outcomes (3)
Change in Global Rating of Change Score
Measured: 1 week, 4 weeks, 3 months
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.
Measured: Baseline, 1 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Jun 2017
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167710
- Sponsor's protocol ID
- AAMT0010
- Status last verified
- Sep 2023
- First submitted
- 24 May 2017
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the numeric pain rating scale, patient-rated tennis elbow evaluation, and tennis elbow function scale in patients with lateral elbow tendinopathy. Physiother Theory Pract. 2025 Aug;41(8):1712-1720. doi: 10.1080/09593985.2025.2450090. Epub 2025 Jan 10.
PubMed 39793982Dunning J, Mourad F, Bliton P, Charlebois C, Gorby P, Zacharko N, Layson B, Maselli F, Young I, Fernandez-de-Las-Penas C. Percutaneous tendon dry needling and thrust manipulation as an adjunct to multimodal physical therapy in patients with lateral elbow tendinopathy: A multicenter randomized clinical trial. Clin Rehabil. 2024 Aug;38(8):1063-1079. doi: 10.1177/02692155241249968. Epub 2024 Apr 26.
PubMed 38676324
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03167710
- Acronym / sponsor ID
- AAMT0010
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling, manipulation stretching | Experimental | Other: Dry Needling, manipulation, stretching |
| manual therapy, exercise, ultrasound | Active comparator | Other: manual therapy, exercise, ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- 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:
- History of surgery to the head/neck or affected upper extremity.
- Psychiatric disorders or cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling, manipulation, stretchingHVLA 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. | Other | dry needling, manipulation stretching |
| manual therapy, exercise, ultrasoundImpairment-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. | Other | manual therapy, exercise, ultrasound |
Primary outcome
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.
3 secondary outcomes
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
Change in Medication Intake (Frequency of medication intake in last week)
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 39793982Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the numeric pain rating scale, patient-rated tennis elbow evaluation, and tennis elbow function scale in patients with lateral elbow tendinopathy. Physiother Theory Pract. 2025 Aug;41(8):1712-1720. doi: 10.1080/09593985.2025.2450090. Epub 2025 Jan 10.
- Derived from this study: PubMed 38676324Dunning J, Mourad F, Bliton P, Charlebois C, Gorby P, Zacharko N, Layson B, Maselli F, Young I, Fernandez-de-Las-Penas C. Percutaneous tendon dry needling and thrust manipulation as an adjunct to multimodal physical therapy in patients with lateral elbow tendinopathy: A multicenter randomized clinical trial. Clin Rehabil. 2024 Aug;38(8):1063-1079. doi: 10.1177/02692155241249968. Epub 2024 Apr 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Dunning, DPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, manipulation, stretching and manual therapy, exercise, ultrasound in people with Lateral Epicondylitis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Elbow pain (NPRS) (Rating Score) (time frame: Baseline, 1 week, 4 weeks, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.