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

Sponsor
Konya Beyhekim Training and Research Hospital
Study ID
NCT07493226
Status
Recruiting
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Conditions

  • Adhesive Capsulitis
  • Frozen Shoulder
  • NSAID (Non-Steroidal Anti-Inflammatory Drug)
  • Neuropathic Pain
  • Nociplastic Pain
  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 25, 2026
Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: propionic acid derivatives
    Patients will be given oral tablets of ibuprofen or naproxen in this group.
  • Active Comparator: acetic acid derivatives
    Patients will be given oral tablets of etodolac or diclofenac in this group.
  • Active Comparator: oxicam derivatives
    Patients will be given oral tablets of meloxicam or lornoxicam in this group.

Primary Outcome Measure

VAS pain (0-10) (night and movement) [ Time Frame: Baseline, Week 1, and Week 2 ]

Central Contacts

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