Cubzac Les Ponts, France
Structure and Function of the Upper Trapezius and Its Role in Chronic Shoulder Pain: an Investigation of Kinematics, Morphology, Muscle Quality and Activation Distribution
Phase
N/ASpan
108 weeksSponsor
National Yang Ming Chiao Tung UniversityRecruiting
Healthy Volunteers
Treatment of Shoulder Osteoarthritis
Phase
N/ASpan
92 weeksSponsor
Gramercy Pain CenterRecruiting
Pulsed Radiofrequency One or Three Nerves for Chronic Shoulder Pain. A Prospective, Randomized, Double-blind Study
Background: It's believed that PRf of the suprascapular nerve is a safe and reliable treatment for shoulder pain. But PRF of the suprascapular nerve may be less effective than intra-articular steroid injections (Eyigor et al., 2010). There is also evidence that even test, diagnostic suprascapular nerve blockade in some patients may not give a satisfactory analgesic effect (Sinha et al., 2020). Probably, the unsatisfactory results of PRF suprascapular nerve as a search for a solution force the use of standard thermal RF ablation. (Bone et al., 2013) It is possible to expect a greater clinical effect from the combination of PRF of the three main articular nerves of the suprascapular, axillary and lateral pectoral nerves than from PRF of the suprascapular nerve alone. Nevertheless, having the task of obtaining the maximum effect from PRF, it seems important to maintain a balance between inevitable intervention and excessive intervention, considering that any intervention is associated with the risk of complications. Methods: The study is planned to include 142 adult patients who are planned to have PRF of the suprascapular nerve due to the presence of chronic shoulder pain.The study is planned as a prospective randomized double-blind controlled trial. According to inclusion / exclusion criteria, written informed consent signing, patients will be randomized in a 1: 1 ratio into two groups: PRF of the suprascapular nerve (n=71) and PRF of the suprascapular, axillary and lateral pectoral nerves (n=71). Patients will be evaluated by a physician 4 weeks and 16 weeks after discharge to receive information on treatment results. Sample size assessment: To identify differences of 5 points on the SPADI scale at a 5% significance level with 80% power, assuming an expected mean SPADI of 25.5 points and SD - 10.1 according to the study by Korkmaz et al 2010, 64 people will be required for each group. The number 128 was increased to 142 in the sample in order to compensate for observation losses.
Phase
N/ASpan
143 weeksSponsor
Saint Petersburg State University, RussiaRecruiting
Pulsed Radiofrequency of Suprascapular Nerve and Shoulder Joint for Chronic Shoulder Pain
Introduction After spinal and knee pain, shoulder pain is estimated to be the third most common type of musculoskeletal pain, causing considerable psychosocial impact if progressing to the chronic phase. While majority of patients with shoulder pain recover within few months, over 40% of patients have persisting symptoms after 12 months. Establishing a treatment strategy for shoulder pain can be challenging, as the effectiveness of many treatment options is unclear. Non-surgical strategies are preferred in the first-line management, with physiotherapy being of the treatment of choice in the majority of cases. Physiotherapy, pain medication and corticosteroid injections (CSI) are used but the effectiveness of these interventions may be insufficient. Corticosteroid injections are often used in treatment of shoulder pain, though there is no clear evidence of long-term benefit. It has been reported that CSI might lead to adverse events such as tendon degeneration, cutaneous atrophy or infection. In addition, CSI can cause systemic side effects including changes in the hypothalamic-pituitary-adrenal axis function and elevated blood glucose levels. Therefore, safer pain management options with more long-lasting pain relief are sought. The suprascapular nerve derives from the ventral rami of cervical spinal nerves C4, C5, and C6 and arises from the upper trunk of the brachial plexus, contributes approximately 70% of the sensory innervation to the shoulder joint. Suprascapular nerve blocks have been used to manage acute and chronic shoulder pain, although the efficacy of treatment alters in different studies and when compared to other treatment options. The short duration of action of local anesthetics raises the question of their efficacy in the management of chronic shoulder conditions. In addition to SSNB, pulsed radiofrequency stimulation (pRF) has also been researched for its potentially greater and longer-lasting outcomes when comparing to local anesthetics. There has been limited numbers of reviews specifically investigating the usefulness of SSNB for the treatment of chronic shoulder pain. Liu et al. concluded in their review pRF treatment to result in good efficiency in shoulder patients with no significant complications reported. The pain relief could last several months. Only few case reports have been made on pRF treatment of the glenohumeral joint. Considering the adverse effects of corticosteroids, SSNB with local anesthetics could be regarded as a potential alternative for pain relief in patients who have adhesive capsulitis. Our earlier results suggested additional therapeutic benefit obtained when pRF for both suprascapular nerve and shoulder joint was performed in addition to physiotherapy. The aim of this study was to compare whether pRF treatment of both glenohumeral joint and suprascapular nerve provided additional clinical benefits compared to suprascapular nerve block or pRF treatment of suprascapular nerve only. The rehabilitation included also individual functional training and treatment as recommended by the national task group. Method This randomized controlled trial will follow the Consolidated Standards of Reporting Trials Statement; it will be performed at Central Hospital in Satakunta, Pori, Finland. The study has been approved by the local Research Ethics Committee (SS/1184/13.01/2018). The sample size estimate was obtained to detect differences between the treatment groups in relation to the primary outcome of the study after the intervention. Kukkonen's et al. study estimated the clinically important minimal difference in CM score in 10.4 points in patients with rotator cuff rupture after 3 months of surgical treatment by the arthroscopic method. The estimated sample size of 45 patients per group, total of 135patients, would reach 90% power to detect a 10.4 difference between the groups in the SPADI instrument follow-up score with a standard deviation of up to 15 points with a significance level of 5% using a t-Student test. Predicting a loss of around 10% at 6 months follow-up, we aim to recruit 50 patients per group. The placebo response is usually estimated as high as 30%. Using calculation of difference between proportions, the sample size was estimated as 50 patients total. Randomization 1:1:1 is performed. Patients will be consecutively allocated to one of three proposed treatment methods. The software R was used to generate a randomization list, considering 150 patients included in the study and the same probability of allocation for methods of pain treatment intervention. Patients with shoulder pain > 3 months duration, clinical and imaging confirmation of adhesive capsulitis, tendinosis, arthritis, rotator cuff or capsular tears are eligible for participation. Failure of conservative medical therapy is documented. Exclusion criteria comprised refusal to participate, extrinsic source of shoulder pain (e.g., cervical radiculopathy) and pain related to bony fracture. All patients are at first evaluated by specialist in physical medicine and rehabilitation who use ultrasound and clinical examination to estimate shoulder function. Patients who have more specific shoulder dysfunction based on subjective symptoms and clinical evaluation are asked to participate this intervention study. Of totally around 300 consecutive patients who receive pRF on the suprascapular nerve and shoulder joint, 150 consecutive patients are estimated voluntarily participate the study. Primary outcomes, such as Shoulder Pain and Disability Index ,15D self-administered measure of health-related quality of life and working ability are measured. This study is also part of the quality register study of the unit. Our standardized patient surveys cover demographic data, level of education, work status and future outlook, pain intensity, psychological factors, measurements of activity/participation and health-related quality of life (MPI, HAD SF-36, EQ-5D,CPAQ;Tampa,ISI). Those patients, who report no pain relief at 2-month follow-up and are dissatisfied, have an option to undergo pRF procedure any time after the first follow-up visit. Patients are able to dropout from the study any time. The randomization will be carried out by assisting nurse and delivered in sealed envelopes marked SSPS "subscapularis" (suprascapular nerve block), " pRF suprascapular" (pRF stimulation of suprascapular nerve) or "suprascapualar + joint" (pRF stimulation both suprascapular nerve and shoulder joint). Patient will be blinded. Two operators to minimize individual technical differences perform all procedures. Physician who did not treat the patient primarily and did not know which treatment patient received will conduct follow up estimation (pretreatment, 10 and 30 weeks after intervention). The groups will be compared according to the presence of categorical clinical outcomes by Chi-square or Fisher's exact tests, depending on the distribution observed after data collection. The analyzes will be performed with the aid of the SPSS program, considering a significance level of 5%. Demographic variables will be compared using a t-test or chi-squared test for continuous and categorical variables, respectively. Repeated measures ANOVA will be utilized for the primary outcome of Pain NRS and the secondary outcomes of the SPADI and AROM. Planned contrasts examining the linear trend effect of each group's scores over time were also included in the analysis. For the HRQoL scale, paired-sample t-tests will be conducted to compare groups, at each time. Interventions All patients will be offered conservative treatment including pharmacotherapy (opioid analgesics, NSAIDs, paracetamol, adjuvant medication) and physiotherapy. Physiotherapy program based on manual therapy intervention focus on increasing function and pain control. Physical training is largely based on specific movements supervised by qualified physiotherapists. The emphasis is on individual training program, and on learning a functional use of the arm. PRF treatment and nerve block will be performed under ultrasound guidance. First, the suprascapular notch is identified using ultrasound with the patient in the sitting position, shoulders relaxed and forearms placed on the thighs. The puncture site is located on the line dividing the upper-outer quadrant of the scapula approximately 2.5 cm from the top. Following the puncture, an isolated radiofrequency 23-G 60 mm needle with a 5 mm active tip (Top Neuropole needle XE 60 mm 23G) is introduced perpendicularly to the skin in all planes. Selective stimulation of motor fibers (50 Hz) commenced after the needle tip had penetrated into the suprascapular notch. Motoric response or paresthesia at a voltage between 0.3 and 0.5 V is sought. Envelopes marked SSPS "supraspinatus" will result in injection of 1 ml Lidocaine (10%) and "pRF suprascapularis" or "suprascapualris+joint" result in pRF stimulation, a 4-minute cycle of pRF with STP (Sluijter Teixeira Pulsed Poisson) program (TOP Lesion Generator TLG-10, Equip Medikey BV, The Netherlands) will be performed. One ml Lidocaine (10%) will be injected at the end of therapy since irritation of nerve fibers by the electrical field (without thermolesion) has been described as occurring frequently. Shoulder joint RF stimulation procedure use posterior approach. The sulcus between the head of the humerus and acromion is identified by ultrasound. The needle is inserted 2-3cm inferior and medial to the posterolateral corner of the acromion and directed anteriorly towards the coracoid process. An isolated radiofrequency 23-G 60 mm needle with a 5 mm active tip (Top Neuropole needle XE 60 mm 23G) will be introduced perpendicularly to the skin in all planes completely into the joint. First, 0,1-0,2 ml Lidocaine (10%) will be injected after puncture of skin and after pRF treatment 0,8 ml in the shoulder joint. Joint capsule stimulation, a 4 minute cycle of pRF with STP program is performed. Pain VAS, glenohumeral joint active range of motion and any complications will be recorded before discharge. The patients receive contact details of an available nurse prior to discharge. Next week after the RF-stimulation, we recommend restart of physiotherapy intervention focused on increasing function and pain control. Average rehabilitation time is calculated to be three months and on average patients have six consultations (1-12) in 6 months. MEASUREMENTS Prior to the first MD appointment, participants are asked to compleat questionnaire. At the first appointment, using standardized clinical data forms; MD record the history of the participant's shoulder problem and clinical examination findings. In addition to active and passive ranges of motion, Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI), are recorded to assess shoulder function. The SPADI is a patient administered questionnaire consisting of 13 items divided into two subscales: pain (5 questions) and disability (8 questions). The pain and disability subscales are scored separately and then calculated into a total SPADI score, with higher scores demonstrating increased pain and disability. We also included 15D self-administered measure of health-related quality of life (HRQoL). 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) and it can be used as a profile and single index score measure. The single index score (15D score) on a 0-1 scale, representing the overall HRQoL, is calculated. Participants will be followed during 6 months, and subjective and objective outcome variables will be recorded for primary outcome instruments at 2 and 6 months and secondary outcome instruments at 6 months follow-up.
Phase
N/ASpan
105 weeksSponsor
SatasairaalaRecruiting
Healthy Volunteers
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
Subacromial bursitis is one of the major causes of chronic refractory shoulder pain. It can cause patients with shoulder pain when shoulder exercise and heavy lifting and limiting the range of motion. It can also influence the sleep quality due to pain symptoms of the shoulder. Usually, these patients had limited response to medication and physical modality. Steroid injection was often adopted for intervention, but the adverse effects should be considered. Therefore, prolotherapy was taken as an alternative treatment for chronic subacromial bursitis. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at the lesion site. Hyperosmolar dextrose appears to be the most commonly used agent today. The aim of this study is to investigate hypertonic injections in subacromial bursitis patients about clinical and ultrasound image presentation. The investigators conducted a double-blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with subacromial bursitis. In the study group, the echo guide 20% dextrose water was injected into the lesion site, and the control group received the echo guide steroid injection. ROM, SPADI, VAS, x-ray, and ultrasound data were obtained at baseline. At weeks 2, 6, 12, ROM, SPADI, VAS, and ultrasound data were evaluated. The ANOVA and independent t-test are applied for analysis by SPSS 20.0 with a P value less than 0.05 as statistical significance.
Phase
N/ASpan
30 weeksSponsor
Taipei Medical University Shuang Ho HospitalRecruiting
Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Shoulder pain is a potentially debilitating musculoskeletal condition, with functional, physical, and psychological impact. Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain. In this scenario, interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model. In this context, Cognitive Functional Therapy (CFT) emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain, which is divided into three approaches to reduce pain and disability: (1) understanding pain, (2) controlled exposure, and (3) lifestyle change. The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain.
Phase
N/ASpan
28 weeksSponsor
Federal University of ParaíbaRecruiting
Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain
This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.
Phase
N/ASpan
93 weeksSponsor
Federal University of ParaíbaRecruiting
Pain Managment in Chronic Shoulder Pain
Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain . The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient . An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) . Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.
Phase
N/ASpan
57 weeksSponsor
Ain Shams UniversityRecruiting
SPR PNS for Chronic Shoulder Pain
Background Chronic degenerative changes in the shoulder are a frequent source of debilitating chronic pain. In particular, osteoarthritis of the shoulder has been estimated to affect up to 32.8% of the adult population over the age of 60, and OA in general is one of the most frequent causes of disability in the United States.1 OA impacts the quality of life of tens of millions of Americans and carries a significant economic burden of over $60 billion in the U.S. each year.2 Degenerative joint disease in the shoulder is commonly managed with physical therapy and over-the-counter medications, but these modalities can be insufficient for pain management as degeneration progresses.3 Corticosteroid injections, radiofrequency ablations, and even partial or total shoulder arthroplasty are used to treat advanced cases3, and these interventions often either have limited long-term effectiveness or are associated with significant invasiveness or other side effects and complications. Peripheral nerve stimulation (PNS) is a neuromodulatory technique that seeks to provide pain relief through stimulation of the nerves that innervate the shoulder (e.g., the suprascapular nerve and axillary nerve). A novel, 60-day percutaneous PNS system that is FDA-cleared has shown effectiveness for chronic shoulder pain following stroke and shoulder impingement syndrome4-15, and has demonstrated the potential to provide sustained relief following the short-term, 60-day treatment.8, 15-18 The mechanism of action of neuropathic pain in osteoarthritis is proposed to be via peripheral sensitization (e.g., axillary and suprascapular nerves) that leads to subsequent upstream hypersensitization of the central nervous system; the proposed mechanism of long-term pain relief with 60-day PNS via reconditioning of the CNS to reverse hypersensitization therefore suggests that the treatment may be effective for degenerative shoulder including OA.19, 20 However, no study has prospectively evaluated the use of 60-day, percutaneous PNS for the treatment of debilitating pain associated with degenerative changes in the shoulder. The goal of this study is therefore to collect data on the use of 60-day PNS for the treatment of chronic pain associated with degenerative shoulder. Objectives The study objective is to gather post-market data regarding the effectiveness of the SPRINT PNS System for the treatment of chronic shoulder pain due to degenerative changes of the shoulder.
Phase
N/ASpan
108 weeksSponsor
International Spine, Pain and Performance CenterRecruiting
Healthy Volunteers
Myofascial Dysfunction in Post Stroke Shoulder Pain
Aim 1: Quantify the extent of HA accumulation in shoulder muscles using T1rho MRI before and after treatment with hyaluronidase injections versus placebo in patients with PSSP. Hypothesis: The primary objective will be to demonstrate that dysfunctional shoulder girdle muscles on the paretic side in patients with PSSP will show decreased T1ρ relaxation times in the infraspinatus muscle after treatment with hyaluronidase injections compared with placebo 5-7 weeks post-injection. Aim 2. Determine maximum sheer strain in shoulder muscles using US shear strain mapping before and after treatment with hyaluronidase injections versus placebo in patients with PSSP. Research Hypothesis: Shear strain on the paretic side in patients with PSSP measured using ultrasound shear mobility between the pectoralis major and minor muscles will decrease after treatment with hyaluronidase injections compared with placebo 5-7 weeks post-injection. Aim 3. Assess the impact of hyaluronidase injections compared with placebo on shoulder pain, pain free range of motion, upper limb motor impairment, function and quality of life in patients with PSSP. Hypothesis: Hyaluronidase injections compared with placebo in patients with PSSP will lead to (1) reduced pain as assessed using the pain questionnaires and lower pain-pressure thresholds with quantitative sensory testing using an algometer; (2) increased pain free range of motion in most affected shoulder joints; (3) reduced upper limb motor impairment measured using the Fugl-Meyer Scale; (4) increased function measured using the Wolf Motor Function Test; and (5) improved quality of life measured using the Stroke Specific Quality of Life scale.
Phase
2Span
179 weeksSponsor
Johns Hopkins UniversityRecruiting