Adhesive Capsulitis, Frozen Shoulder, Neuropathic Pain, Nociplastic Pain, NSAID (Non-Steroidal Anti-Inflammatory Drug), Shoulder Pain
Conditions
Keywords
frozen shoulder, adhesive capsulitis, shoulder pain, pain phenotypes, exercises, Nonsteroidal Anti-Inflammatory Drugs
Brief summary
Patients aged 18-75 years who present to a tertiary rehabilitation hospital with shoulder pain and restricted range of motion, and who consent to participate, will be included in the study. Eligibility will be determined based on predefined inclusion and exclusion criteria. Eligible patients will be randomly assigned to receive one of several nonsteroidal anti-inflammatory drugs (NSAIDs) with differing chemical properties (e.g., diclofenac, meloxicam, or indomethacin), in combination with a home-based exercise program for shoulder adhesive capsulitis. Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended.Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and questionnaires, and it will be determined which pain types derive greater benefit from NSAIDs. Follow-up assessments will be conducted at the end of the first and second weeks. At the first-week follow-up, pain intensity will be evaluated using the Visual Analog Scale (VAS). If the treatment is deemed effective (defined as a ≥3-point reduction or ≥50% decrease in VAS), the same NSAID will be continued for an additional week; otherwise, it will be switched to an alternative NSAID with a different biochemical profile (group). The outcomes assessments will be performed by a blinded evaluator to minimize bias.
Detailed description
This study will include patients presenting to the Physical Medicine and Rehabilitation outpatient clinics of Konya Beyhekim Training and Research Hospital with shoulder pain and restricted range of motion, who are clinically diagnosed with frozen shoulder following a comprehensive evaluation. All patients will be prescribed non-steroidal anti-inflammatory drugs (NSAIDs) as part of analgesic treatment. A total of 120 consecutive patients aged 18-75 years, with shoulder pain lasting at least one month and diagnosed with frozen shoulder after appropriate differential diagnosis, who consent to participate, will be enrolled. All participants will provide written informed consent for study participation. Sociodemographic characteristics and clinical examination findings will be recorded for all participants. As part of the clinical examination, patients will be evaluated for diagnosis and differential diagnosis based on the presence of impingement tests, drop arm sign, shoulder ultrasonography (presence of significant effusion, rotator cuff tear), and plain radiography. Following assessment according to predefined inclusion and exclusion criteria, patients will be randomized (block randomization) to receive one of several NSAIDs with distinct chemical properties (e.g., diclofenac, meloxicam, or indomethacin). Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended. Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and questionnaires, and it will be determined which pain types derive greater benefit from NSAIDs. As a home exercise program, patients will perform range-of-motion exercises, Codman exercises, isometric strengthening, and stretching within their self-limited pain threshold. Exercise adherence will be monitored at the first and second visits, and patients with less than 70% adherence will be excluded. Patients will be re-evaluated one week after treatment initiation. Pain will be assessed based on perceived pain relief, Visual Analog Scale (VAS; 0-10), and overall treatment effectiveness. Patients demonstrating a clinically meaningful response-defined as at least a 50% reduction in pain or a decrease of ≥3 points on the VAS-will continue the same NSAID for an additional week, provided no adverse effects or contraindications arise. These patients will undergo a final evaluation at the end of the second week. For patients who do not show sufficient improvement at the first-week assessment, the prescribed NSAID will be randomly switched to an alternative NSAID agent with different chemical properties (including both switching within the same chemical class-for example, from diclofenac to etodolac-and switching to a different chemical class with distinct properties-for example, from diclofenac to meloxicam). These patients will continue treatment for an additional week and will be reassessed at the end of the second week, at which point treatment effectiveness will be recorded. After two weeks, the medical treatment and exercise program will be completed, and the outcomes at the end of week 2 will be assessed by a blinded evaluator, marking the completion of the study. In addition, any NSAID-related side effects (dyspepsia, nausea, headache, hypertension, gastrointestinal hemorrhage, etc.) will be recorded, and patient satisfaction (subjective impression of improvement) level will be assessed by a blind investigator using a Likert-type questionnaire (1; not satisfied at all, 5; very satisfied). The study will be concluded once a total of 120 consecutive patients meeting the inclusion criteria have been enrolled.
Interventions
DRUGPropionic acid deriaves
Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of ibuprofen or naproxen
DRUGacetic acid derivatives
Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of etodolac or diclofenac.
DRUGoxicam derivatives
Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of meloxicam or lornoxicam.
Sponsors
Konya Beyhekim Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Being between 18-75 years of age 2. Having shoulder pain that has lasted for at least one month and being diagnosed with primary frozen shoulder 3. Having a VAS pain level ≥ 4/10 4. Having ≥30 degrees of range of motion restriction in at least two planes (flexion, abduction, or external rotation) 5. Not having any
Exclusion criteria
and agreeing to participate in the study voluntarily
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion (ROM) | Baseline, and Week 2 | Movements of the affected shoulder (flexion, abduction, internal and external rotation) will be measured and recorded using a goniometer. The presence of limitation will be assessed by comparing it to the unaffected side. |
| SPADI :Shoulder Pain and Disability Index | Baseline, and Week 2 | The Shoulder Pain and Functionality Index (SPADI) is a self-report scale developed to assess the severity of shoulder pain and its impact on functionality. The scale consists of two sub-sections: pain (5 items) and functionality (8 items). Each item is scored from 0 (no pain or difficulty) to 10 (unbearable pain or extreme difficulty). The total score ranges from 0 to 100; higher scores indicate more severe pain and loss of function. |
| VAS pain (0-10) (night and movement) | Baseline, Week 1, and Week 2 | Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality Scale | Baseline, and Week 2 | Sleep quality during the preceding week was evaluated using the Single-Item Sleep Quality Scale (SQS), a brief and practical instrument derived from item 6 of the Pittsburgh Sleep Quality Index. The scale evaluates sleep quality using a VAS ranging from 0 to 10, which is then categorized on a 0-4 scale, ranging from 0 (terrible) to 4 (excellent)." |
| Pain Catastrophizing Scale | Baseline, and Week 2 | This is a 13-item self-report questionnaire, scored from 0 to 52, that measures negative cognitive and emotional responses to pain experiences, such as helplessness, exaggeration (magnification), and rumination. It is widely used in chronic pain management and in determining a patient's sensitivity to pain. |
| Patient satisfaction (subjective impression of improvement) | 2nd week | Patient satisfaction subjective evaluation is the measurement of a patient's personal perceptions, feelings, and expectations regarding the healthcare service received, physician communication, hospital environment, and treatment outcomes, through surveys or interviews. Patient satisfaction (subjective impression of improvement) was assessed using a five-point Likert-type scale. Response options were defined as follows: 1, "no satisfaction at all"; 2, "not satisfied"; 3, neutral (no positive or negative effect); 4, "satisfied"; and 5, "very satisfied." |
| DN4 Neuropathic Pain Questionnaire | Baseline | This is a questionnaire that compiles symptoms and findings associated with neuropathic pain. It is scored on a scale of 0-10. A score above 4 is considered indicative of neuropathic pain. |
| Central Sensitization Inventory | Baseline | This is a 25-item self-report scale that measures central nervous system hypersensitivity to normal stimuli (central sensitization), a condition that plays a role in the pathophysiology of chronic pain. It aids in diagnosis of chronic pain syndromes such as fibromyalgia by scoring common somatic and emotional symptoms on a scale of 0-100. |
Countries
Turkey (Türkiye)
Contacts
CONTACTRukiye Hilal Taygurt Md., principal investigator
CONTACTfurkan taygurt Md., relative
STUDY_DIRECTORRamazan Yılmaz Associate Professor Dr., advisor
Konya Beyhekim Training and Research Hospital
Outcome results
None listed