Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKonya Beyhekim Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being between 18-75 years of age

Having shoulder pain that has lasted for at least one month and being diagnosed with primary frozen shoulder

Having a VAS pain level ≥ 4/10

Having ≥30 degrees of range of motion restriction in at least two planes (flexion, abduction, or external rotation)

Disqualifiers

Patients with a history of shoulder trauma, those with musculoskeletal disorders characterized by pain and loss of function in the affected extremity (such as lateral epicondylitis, flexor tendon injury, de Quervein's tenosynovitis)

Presence of neurological involvement such as stroke, brachial plexus injury, Parkinson's disease, and cervical spine injury with or without radiculopathy

History of shoulder surgery, malignancy or tumor in the shoulder, those who have undergone shoulder manipulation

Presence of shoulder arthritis, rotator cuff tear or other shoulder injuries, thoracic outlet syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propionic acid deriaves

    Drug

    Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of ibuprofen or naproxen

  • acetic acid derivatives

    Drug

    Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of etodolac or diclofenac.

  • oxicam derivatives

    Drug

    Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of meloxicam or lornoxicam.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: propionic acid derivativesActive comparator 1 intervention
Group B: acetic acid derivativesActive comparator 1 intervention
Group C: oxicam derivativesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

VAS pain (0-10) (night and movement)

Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain.

Time frame
Baseline, Week 1, and Week 2
2

Range of motion (ROM)

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.

Time frame
Baseline, and Week 2
3

SPADI :Shoulder Pain and Disability Index

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.

Time frame
Baseline, and Week 2

Secondary outcomes

1

DN4 Neuropathic Pain Questionnaire

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.

Time frame
Baseline
2

Central Sensitization Inventory

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.

Time frame
Baseline
3

Sleep Quality Scale

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)."

Time frame
Baseline, and Week 2
4

Pain Catastrophizing Scale

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.

Time frame
Baseline, and Week 2

Other outcomes

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