Epicondylitis, Lateral HumeralNCT02521298
Treatment of Lateral Elbow Tendinopathy
A study testing Strength Training, Cortico-Steroid Injection. Depomedrol 40mg/1ml. and Dry Needling in people with Epicondylitis, Lateral Humeral, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epicondylitis, Lateral Humeral
- What is being tested?
- Strength Training, Cortico-Steroid Injection. Depomedrol 40mg/1ml. and Dry Needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to 5 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain around the lateral part of the elbow joint for more than 4 weeks.
- Pain on palpation of the proximal part of the common extensor tendon.
- Pain reproduced with resisted dorsiflexion of the wrist.
- Dash score > 30.
- Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).
Who cannot join
- American Society of Anesthesiologists (ASA) > 2 (mild systemic disease).
- Patients with symptoms consistent with differential diagnoses such as:
- referred pain,
- radiohumeral synovitis and bursitis,
- posterior interosseous nerve entrapment (radial tunnel syndrome),
- osteoarthritis of the elbow, and
- prior injections or acupuncture around the elbow joint within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo
This study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial.
Read the detailed description
The prevalence of lateral elbow tendinopathy is prevalence of 1-3%, with a peak incidence between 35-50 years of age (Green et al., 2002). The main symptoms are pain over the lateral humeral epicondyle upon palpation and pain full resisted dorsiflexion of the wrist. Ultrasonographic changes include hyper-/hypo-echoic areas and increased doppler signal in the most proximal part of the common extensor tendon. The condition is often self-limiting, however full recovery often takes months to years and recurrence is common. Several different treatment modalities are used in order to increase tendon healing and decrease time to recovery. Deep transverse friction massage showed no significant effect on pain, grip strength or function relative to other physiotherapy modalities (Brosseau et al., 2002). Anti-inflammatory treatment with NSAID's or corticosteroids is typically effective in the short term, however on a longer term there is a poorer outcome than with other treatment strategies including exercise (Coombes et al., 2010). Surgery does not seem to have any beneficial effect (Buchbinder et al., 2011), and there are no conclusive data regarding the use of orthotic devises for the treatment of lateral elbow tendinopathy (Struijs et al., 2002). Eccentric exercise of the extensor muscles has been shown to reduced pain, increase muscle strength, and decrease tendon thickness and time to return to sport (Croisier et al., 2007).
Loading of human tendon leads to increased tendon collagen synthesis, and interestingly, tendon tissue sampling (biopsies), which causes a minor trauma to the tendon has been shown to increase the level of growth factors locally and stimulate tendon collagen synthesis (Magnusson et al., 2010).
It is hypothesized that both minimal tissue damage and anti-inflammatory treatment could increase tendon healing and decrease time to recovery, when combined with mechanical loading.
- Conditions
- Epicondylitis, Lateral Humeral
- Being tested
- Strength Training, Placebo, Cortico-Steroid Injection. Depomedrol 40mg/1ml., Dry Needling
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingOther
PlaceboProcedure or surgery
Cortico-Steroid Injection. Depomedrol 40mg/1ml.Drug
Dry NeedlingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Strength Training + Placebo | Active comparator | Strength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8.
Placebo: Ultrasound-guided subcutaneous injection of 2 ml isotonic saline over the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. Receives: Other: Strength Training; Procedure: Placebo |
| Strength Training + Cortico-Steroid Inj. | Experimental | Strength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8.
Cortico-Steroid Injection: Ultrasound-guided injection of 1 ml depomedrol 40 mg/ml + 1 ml lidocaine 10 mg/ml deep to the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. Receives: Other: Strength Training; Drug: Cortico-Steroid Injection. Depomedrol 40mg/1ml. |
| Strength Training + Dry Needling | Experimental | Strength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8.
Dry Needling: Ultrasound-guided penetration of the proximal part of the common extensor tendon origin is repeated 10 times using a 0,8 mm needle, followed by subcutaneous injection of 2 ml isotonic saline superficial to the tendon. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. Receives: Other: Strength Training; Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
Measured: Baseline, week 17, 30, and 56.
Secondary outcomes (2)
Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Including isometric wrist extension force and isometric grip strength.
Measured: Baseline, week 17, 30, and 56.
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Week 0-2, 30 and 56. Including: 1) Irregular appearance of the tendon, 2) Hypo-/hyper-echoic changes, 3) Pathological doppler signal, 4) Tendon thickness.
Measured: Baseline, week 30, and 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Epicondylitis, Lateral HumeralStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Doessing, M.D., PhD, Bispebjerg Hospital
- Investigators
- Michael Kjaer, M.D., PhD., Study director, Bispebjerg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521298
- Sponsor's protocol ID
- H-15002993
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2015
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, Assendelft W. Acupuncture for lateral elbow pain. Cochrane Database Syst Rev. 2002;2002(1):CD003527. doi: 10.1002/14651858.CD003527.
PubMed 11869671Brosseau L, Casimiro L, Milne S, Robinson V, Shea B, Tugwell P, Wells G. Deep transverse friction massage for treating tendinitis. Cochrane Database Syst Rev. 2002;(4):CD003528. doi: 10.1002/14651858.CD003528.
PubMed 12519601Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.
PubMed 20970844Croisier JL, Foidart-Dessalle M, Tinant F, Crielaard JM, Forthomme B. An isokinetic eccentric programme for the management of chronic lateral epicondylar tendinopathy. Br J Sports Med. 2007 Apr;41(4):269-75. doi: 10.1136/bjsm.2006.033324. Epub 2007 Jan 15.
PubMed 17224433Magnusson SP, Langberg H, Kjaer M. The pathogenesis of tendinopathy: balancing the response to loading. Nat Rev Rheumatol. 2010 May;6(5):262-8. doi: 10.1038/nrrheum.2010.43. Epub 2010 Mar 23.
PubMed 20308995Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
PubMed 11869609Couppe C, Dossing S, Bulow PM, Siersma VD, Zilmer CK, Bang CW, Hoffner R, Kracht M, Hogg P, Edstrom G, Kjaer M, Magnusson SP. Effects of Heavy Slow Resistance Training Combined With Corticosteroid Injections or Tendon Needling in Patients With Lateral Elbow Tendinopathy: A 3-Arm Randomized Double-Blinded Placebo-Controlled Study. Am J Sports Med. 2022 Aug;50(10):2787-2796. doi: 10.1177/03635465221110214. Epub 2022 Jul 22.
PubMed 35867777
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo
- ClinicalTrials.gov ID
- NCT02521298
- Acronym / sponsor ID
- H-15002993
- Conditions
- Epicondylitis, Lateral Humeral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
This study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial.
Detailed description
The prevalence of lateral elbow tendinopathy is prevalence of 1-3%, with a peak incidence between 35-50 years of age (Green et al., 2002). The main symptoms are pain over the lateral humeral epicondyle upon palpation and pain full resisted dorsiflexion of the wrist. Ultrasonographic changes include hyper-/hypo-echoic areas and increased doppler signal in the most proximal part of the common extensor tendon. The condition is often self-limiting, however full recovery often takes months to years and recurrence is common. Several different treatment modalities are used in order to increase tendon healing and decrease time to recovery. Deep transverse friction massage showed no significant effect on pain, grip strength or function relative to other physiotherapy modalities (Brosseau et al., 2002). Anti-inflammatory treatment with NSAID's or corticosteroids is typically effective in the short term, however on a longer term there is a poorer outcome than with other treatment strategies including exercise (Coombes et al., 2010). Surgery does not seem to have any beneficial effect (Buchbinder et al., 2011), and there are no conclusive data regarding the use of orthotic devises for the treatment of lateral elbow tendinopathy (Struijs et al., 2002). Eccentric exercise of the extensor muscles has been shown to reduced pain, increase muscle strength, and decrease tendon thickness and time to return to sport (Croisier et al., 2007).
Loading of human tendon leads to increased tendon collagen synthesis, and interestingly, tendon tissue sampling (biopsies), which causes a minor trauma to the tendon has been shown to increase the level of growth factors locally and stimulate tendon collagen synthesis (Magnusson et al., 2010).
It is hypothesized that both minimal tissue damage and anti-inflammatory treatment could increase tendon healing and decrease time to recovery, when combined with mechanical loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength Training + Placebo | Active comparator | Other: Strength Training, Procedure: PlaceboStrength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Placebo: Ultrasound-guided subcutaneous injection of 2 ml isotonic saline over the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. |
| Strength Training + Cortico-Steroid Inj. | Experimental | Other: Strength Training, Drug: Cortico-Steroid Injection. Depomedrol 40mg/1ml.Strength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Cortico-Steroid Injection: Ultrasound-guided injection of 1 ml depomedrol 40 mg/ml + 1 ml lidocaine 10 mg/ml deep to the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. |
| Strength Training + Dry Needling | Experimental | Other: Strength Training, Procedure: Dry NeedlingStrength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Dry Needling: Ultrasound-guided penetration of the proximal part of the common extensor tendon origin is repeated 10 times using a 0,8 mm needle, followed by subcutaneous injection of 2 ml isotonic saline superficial to the tendon. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain around the lateral part of the elbow joint for more than 4 weeks.
- Pain on palpation of the proximal part of the common extensor tendon.
- Pain reproduced with resisted dorsiflexion of the wrist.
- Dash score > 30.
- Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) > 2 (mild systemic disease).
- Patients with symptoms consistent with differential diagnoses such as:
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 |
|---|---|---|
| Strength Training | Other | Strength Training + Cortico-Steroid Inj., Strength Training + Dry Needling, Strength Training + Placebo |
| Placebo | Procedure or surgery | Strength Training + Placebo |
| Cortico-Steroid Injection. Depomedrol 40mg/1ml. | Drug | Strength Training + Cortico-Steroid Inj. |
| Dry Needling | Procedure or surgery | Strength Training + Dry Needling |
Primary outcome
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
Time frame: Baseline, week 17, 30, and 56.
2 secondary outcomes
Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Time frame: Baseline, week 17, 30, and 56.
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Time frame: Baseline, week 30, and 56.
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 22 Jul 2020.
- Background: PubMed 11869671Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, Assendelft W. Acupuncture for lateral elbow pain. Cochrane Database Syst Rev. 2002;2002(1):CD003527. doi: 10.1002/14651858.CD003527.
- Background: PubMed 12519601Brosseau L, Casimiro L, Milne S, Robinson V, Shea B, Tugwell P, Wells G. Deep transverse friction massage for treating tendinitis. Cochrane Database Syst Rev. 2002;(4):CD003528. doi: 10.1002/14651858.CD003528.
- Background: PubMed 20970844Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.
- Background: PubMed 17224433Croisier JL, Foidart-Dessalle M, Tinant F, Crielaard JM, Forthomme B. An isokinetic eccentric programme for the management of chronic lateral epicondylar tendinopathy. Br J Sports Med. 2007 Apr;41(4):269-75. doi: 10.1136/bjsm.2006.033324. Epub 2007 Jan 15.
- Background: PubMed 20308995Magnusson SP, Langberg H, Kjaer M. The pathogenesis of tendinopathy: balancing the response to loading. Nat Rev Rheumatol. 2010 May;6(5):262-8. doi: 10.1038/nrrheum.2010.43. Epub 2010 Mar 23.
- Background: PubMed 11869609Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
- Derived from this study: PubMed 35867777Couppe C, Dossing S, Bulow PM, Siersma VD, Zilmer CK, Bang CW, Hoffner R, Kracht M, Hogg P, Edstrom G, Kjaer M, Magnusson SP. Effects of Heavy Slow Resistance Training Combined With Corticosteroid Injections or Tendon Needling in Patients With Lateral Elbow Tendinopathy: A 3-Arm Randomized Double-Blinded Placebo-Controlled Study. Am J Sports Med. 2022 Aug;50(10):2787-2796. doi: 10.1177/03635465221110214. Epub 2022 Jul 22.
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.
Michael Kjaer, M.D., PhD. study director
Bispebjerg Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training, Cortico-Steroid Injection. Depomedrol 40mg/1ml. and Dry Needling in people with Epicondylitis, Lateral Humeral, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 7 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 22 Jul 2020. 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 Denmark. 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 disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC). (time frame: Baseline, week 17, 30, and 56.). 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 NCT02521298, which also lists 7 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 22 Jul 2020.