Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).
排除标准
- •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
研究组 & 干预措施
Strength Training + Placebo
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.
干预措施: Strength Training (Other)
Strength Training + Placebo
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.
干预措施: Placebo (Procedure)
Strength Training + Cortico-Steroid Inj.
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.
干预措施: Strength Training (Other)
Strength Training + Cortico-Steroid Inj.
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.
干预措施: Cortico-Steroid Injection. Depomedrol 40mg/1ml. (Drug)
Strength Training + Dry Needling
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.
干预措施: Strength Training (Other)
Strength Training + Dry Needling
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.
干预措施: Dry Needling (Procedure)
结局指标
主要结局
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
时间窗: Baseline, week 17, 30, and 56.
次要结局
- Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)(Baseline, week 17, 30, and 56.)
- Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.(Baseline, week 30, and 56.)
研究者
Simon Doessing, M.D., PhD
M.D., PhD
Bispebjerg Hospital