An Investigator initiated study comparing individual use of Etorocoxib (to reduce pain and swelling) and Thiocolchicoside (a muscle relaxant) against combined use of Etoroxocib and Thiocolchicoside in patients with pain in different regions of the spine along with muscle rigidity and spams.

Phase 4

Completed

• Conditions: Low back pain, (2) ICD-10 Condition: M542||Cervicalgia,

• Registration Number: CTRI/2023/08/056416
• Lead Sponsor: Dr Shrirang Limaye

Brief Summary

This is a prospective, observational, multicenter, openlabel study to evaluate and compare the safety and efficacy of 150 adultpatients with pain syndrome indifferent regions of the spine, accompanied by muscle tension and spasm at 4sites across India. Prior to being enrolled into the study patients must providewritten authorization to the investigator to use or disclose personal and/orclinical data and meet the study eligibility criteria. Data that would becollected are Anthropometry, patient survey for complaints, Demographic and socialhabits data collection, medical history collection, information collection andassessment of earlier and concomitant therapies, Physical examination, questionnairesand Scales.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-18
• Study Completion: 2023-12-29
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1.Availability of a signed informed consent for study participation, commitment and ability to follow all the Protocol requirements.
• 2.Patients of both genders aged 18 to 65 years inclusive, with an established diagnosis of • musculoskeletal (nonspecific) low back pain (LBP) and/or • musculoskeletal (nonspecific) neck pain (spondylogenic cervicalgia) 3.Compliance with the following diagnostic criteria: • pain, muscle tension, or stiffness that is localized in the neck or between the twelfth pair of ribs and the gluteal sulcus; • pain usually has an aching character of varying intensity, increases with movement in the neck (tilting the head to the side [upper trapezius muscle], moving the arms to the sides [muscle lifting the scapula],bending the head forward, trying to touch the chin to the chest [muscle that straightens the spine])or in the lumbar spine, certain postures, walking and weakens at rest; • absence of symptoms of tension of the nerve roots like tingling, numbness, muscle weakness or increased sensitivity(Lasegue, Wasserman, Matskevich symptoms) 4.The disease course meets the following criteria: • a single episode of pain syndrome lasting at least 24 hours but not more than 3 weeks prior to enrollment in this study, or • a recurrent episode of pain lasting at least 24 hours, but not more than 3 weeks prior to enrollment in this study, provided that the duration of completely asymptomatic periods between relapses is less than 6 months.
• 5.The severity of pain in the neck or lower back after the most painful movement, as assessed by the patient at screening and before randomization using VAS (0-100 mm), is ≥ 40 mm.
• 6.Clinical signs (by physical examination and palpation of muscles) of spasticity in the neck or lower back.
• 7.Pain in the lower back is causing disability(Roland-Morris Disability Questionnaire score ˃ 5 at screening and before randomization), AND/OR Pain in the neck causes disability (Neck Disability Index score ˃ 15 at screening and before randomization).

Exclusion Criteria

• 1.Hypersensitivity to NSAIDs, centrally acting muscle relaxants, paracetamol or any other components of the compared drugs.
• 2.History of Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, rhinitis, angioneurotic oedema, urticaria, or allergic type reactions and respiratory disease induced by NSAIDs. 3.The use of NSAIDs in any dosage form (including oral acetylsalicylic acid as prophylaxis of cardiovascular disorders, at a dose of 75-100 mg/day), non-narcotic and narcotic analgesics in any dosage form within 24 hours prior to enrolling in this study.
• 4.The use of oral corticosteroids, or in the form of intramuscular injection within 30 days prior to enrollment in this study.
• 5.The use of corticosteroids in the form of caudal epidural injections (blockade with local anesthetics and corticosteroids) within 3 months prior to enrollment in this study.
• 6.Spinal or epidural anesthesia and/or lumbar puncture within 3 months prior to enrollment in this study.
• 7.Use of non-drug therapies prohibited by this protocol within 24 hours prior to enrollment in this study.
• 9.Probable specific etiology of pain in the lower back, identified by history: • recent back injury; • malignant neoplasm, even in the case of the tumor eradication; • current infectious or systemic inflammatory disease; • long-term use of corticosteroids; • history of immunodepression, tuberculosis, HIV infection, alcohol and/or drug addiction; • unexplained weight loss, fever.
• 10.Probable specific etiology of pain in the lower back, identified by the nature and localization of pain: • pain that progresses over time that is not relieved by rest ("non-mechanical" pain) radiation of pain to the chest, perineum, rectum, abdomen, or vagina; • association of pain with bowel movements and urination.
• 11.Probable specific etiology of pain in the lower back (including but not limited to the following), identified by CT /MRI as per investigator discretion: • malignant neoplasm; • infection of the vertebrae or discs; • cauda equina syndrome; • compression fracture of the vertebra; • disc herniation and/or lumbar stenosis.
• 12.Signs of radiculopathy and other neurological diseases (paresis, loss of reflexes, sensory disorders, pelvic disorders, etc.).
• 13.History of Erosive and ulcerative changes in the gastric and duodenal mucousa, inflammatory bowel disease or active gastrointestinal bleeding.
• 14.Severe liver dysfunction (serum albumin <25 g/l).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of concomitant use of Etoricoxib tablets 60 mg OD & Thiocolchicoside capsules 4 mg BID versus the mono use of Etoricoxib 60 mg tablets OD (marketed in India) & Thiocolchicoside capsules 4 mg BID (marketed in India) in patients with pain syndrome in different regions of the spine accompanied by muscle tension and spasm	Day 1 to Day 15

Secondary Outcome Measures

Name	Time	Method
To assess the safety & tolerability of concomitant use of Etoricoxib tablets 60 mg OD and Thiocolchicoside capsules 4 mg BID versus the mono use of Etoricoxib 60 mg tablets OD (marketed in India) and Thiocolchicoside capsules 4 mg BID (marketed in India) in patients with pain syndrome in different regions of the spine accompanied by muscle tension and spasm	Day 1 to Day 15

Trial Locations

Locations (4)

Deoyani Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Medipoint Hospitals Pvt Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Noble Hospital PVT LTD; 🇮🇳 Pune, MAHARASHTRA, India

Pawana Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Deoyani Multispeciality Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Shrirang Limaye

Principal investigator

9850811722

drshriranglimaye01@gmail.com