To study the effect of PNT and structured exercises on function and pain of patients with lateral elbow tendinopathy.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a patient reported outcome
measure (PROM) specifically developed for lateral elbow tendinopathy.
Secondary outcome
• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Outcome Measure
- a questionnaire designed to measure physical function and symptoms in
patients with any or several musculoskeletal disorders of the upper limb.
• EQ-5D - a standardized instrument for use as a measure of health outcome
• Two questions concerning patiënt satisfaction
• Questionnaire concerning adherence and possible difficulties with the
structured exercise schedule
• Pain measured using the numerical rating scale (NRS)
Background summary
Lateral Elbow Tendinopathy (LET) is a common cause for chronic pain in the
elbow, where the pain is present for longer than 6 months. (1,2) Currently, the
rationale is that the tendinopathy is the result of the repetitive strain of
the hand, wrist and elbow. However, it can also be initiated by an acute
trauma. In some cases the symptoms of the tendinopathy can be difficult to
treat with resulting persistent pain and restrictions in activities in daily
life.
Multiple treatment methods for LET are described in the literature. (2-8) These
methods can be categorized in conservative, minimal invasive and operative
treatments. Conservative treatment is often long-term physiotherapy ranging
from ten to eighteen months. (3,4) In 90% of the cases conservative treatment
is successful within 12 months. (9-10) It is however unclear what the best
treatment modality is in the 10% where a LET persists and the previous
treatment was without result. There is no current consensus on the treatment
that should be considered as standard in these cases.
Previous studies have shown that percutaneous needle tenotomy (PNT) may be an
effective minimal invasive method for the treatment of LET. (11-13) For this
method multiple microtrauma are administered in the affected tissue using a
needle. The rationale for this is that the subsequent inflammation results in
a decrease of the symptoms. PNT can be performed under local anesthetics (LA).
Therefore, an effect of PNT can also be driven by effects of injection of the
LA through hydrodissection. Injection of an anaesthetic bolus can cause
shearing or compression (mechanical effects) between the surface of the common
extensor tendon and superficial fat plane.(14) This mechanical action together
with neurotoxic and vasoconstrictive effects of the anaesthetics can target the
neovessels and nerves, potentially having a beneficial effect on chronic LET.
Such effects have been observed in chronic patellar and Achilles tendinopathy,
but thus far are not evaluated in LET.
To date, studies on PNT have only been performed in cohort design or with low
numbers. In the Sint Maartenskliniek PNT is used on indication, but thus
without proper scientific support. Our goal is therefore to study in an RCT
with sufficiënt power if PNT under local anaesthetics, together with structured
exercise, is an effective treatment for LET when contrasted with local
anaesthetics, together with structured exercise, and structured exercise alone.
(see protocol for references)
Study objective
To study the effect of PNT and structured exercises on function and pain of
patients with lateral elbow tendinopathy.
Study design
A multicenter, randomized controlled trial with three study groups: 1. PNT and
structured exercise, 2. local anaesthetics (hydrodissection) and structured
exercise, and 3. structured exercise only.
Measurements will be performed at baseline and at 3 months after intervention
in the participating medical centers that recruited the patiënt.
Intervention
Percutaneous needle tenotomy, local anaesthetics and structured exercise
Study burden and risks
Patients participating in this study will not being barred by any additional
benefits or risks other than the regular risks for the treatment with PNT or
local anaesthetics. The questionnaires of the upper extremity do not bring any
extra burden, except an extra time investment of 2x 30 minutes.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
• Age between 18 and 65 years
• Pain in the elbow present for more than 12 months, unresponsive to conservative treatment
• Sonographically proven tendinopathy (hypervascularisation, deep tendon calcifications, hypoechogenic tendon, erosive cortex)
• Concordant pain during compression with a US Probe in the region of the extensor tendons
• Is able to give informed consent
• Is instructable to follow the exercises
Exclusion criteria
• Surgery related to the lateral elbow tendinopathy, including Needle Aspiration of Calcific Deposits (NACD)
• Systemic joint disease such as rheumatoid arthritis etc.
• Rupture or clefts >1cm of the extensor tendons
• Detachment of extensor tendons or tears in collateral ligament
• Contraindication for lidocaïne in accordance to the SPC
• Pregnancy
• Use of anti-inflammatory drugs, such as NSAIDs, steroids, methotrexate, anti-TNF, azathioprine
• Use of anticoagulant drugs which is bridged with acetylsalicylate acid
• Physical, emotional or neurological conditions that would compromise the patient*s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple Sclerosis, etc.)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002822-22-NL |
| CCMO | NL66032.091.18 |