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

NCT07493226 | Recruiting

• 1 other identifier: BeyhekimTRH-RHT2026/5477
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

frozen shoulder; adhesive capsulitis; shoulder pain; pain phenotypes; exercises; Nonsteroidal Anti-Inflammatory Drugs

Outcome Measures

Primary Outcomes (3)

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

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

  Baseline, Week 1, and Week 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.

  Baseline, and Week 2

• 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.

  Baseline, and Week 2

Secondary Outcomes (5)

• DN4 Neuropathic Pain Questionnaire

  Baseline

• Central Sensitization Inventory

  Baseline

• Sleep Quality Scale

  Baseline, and Week 2

• Pain Catastrophizing Scale

  Baseline, and Week 2

• Patient satisfaction (subjective impression of improvement)

  2nd week

Study Arms (3)

propionic acid derivatives

ACTIVE COMPARATOR

Patients will be given oral tablets of ibuprofen or naproxen in this group.

Drug: Propionic acid deriaves

acetic acid derivatives

ACTIVE COMPARATOR

Patients will be given oral tablets of etodolac or diclofenac in this group.

Drug: acetic acid derivatives

oxicam derivatives

ACTIVE COMPARATOR

Patients will be given oral tablets of meloxicam or lornoxicam in this group.

Drug: oxicam derivatives

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

Also known as: İbuprofen, naproksen, Home-based exercises

propionic acid derivatives

acetic acid derivatives DRUG

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

Also known as: etodolac, diclofenac, Home-based exercises

acetic acid derivatives

oxicam derivatives DRUG

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

Also known as: meloxicam, lornoxicam, Home-based exercises

oxicam derivatives

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Systemic disease affecting the shoulder region, severe degeneration or trauma (e.g., osteoarthritis, rheumatoid arthritis, history of labrum or articular cartilage injuries), inflammatory rheumatic diseases
• Those who have received steroid injections into the affected extremity within the last 3 months, those using oral steroids or NSAIDs, those receiving any surgical or interventional treatment, or Planned individuals:
• Those who are pregnant or lactating
• Those with uncontrolled diabetes, heart failure, uncontrolled systemic disease (liver disease, chronic kidney failure, significant endocrine disorders, etc.)
• Those with communication problems, severe psychiatric disorders
• Those allergic to NSAIDs or with any contraindications
• Those with bleeding, coagulation disorders, stomach ulcers, or symptomatic gastritis

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis; Shoulder Pain; Nociplastic Pain; Neuralgia; Motor Activity

Interventions

Ibuprofen; Etodolac; Diclofenac; Meloxicam; lornoxicam

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Thiazines; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Ramazan Yılmaz Associate Professor Dr., advisor

  Konya Beyhekim Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Rukiye Hilal Taygurt Md., principal investigator

CONTACT

+905389122141; rukiyehilalgokce@gmail.com

furkan taygurt Md., relative

CONTACT

+905512203334; furkantaygurt2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)