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IRCT20250514065735N1 IRCT 2025-05-29 Shiraz University of Medical Sciences Comparison of the effectiveness of acupuncture intervention with pharmacological treatment in improving neck pain and stiffness in patients with cervical spondylosis Comparison of the effectiveness of acupuncture intervention with pharmacological treatment in improving neck pain and stiffness in patients with cervical spondylosis - clinical trial 2025-05-26 anticipated 80 Complete https://irct.ir/trial/83568 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization in this study will use a permuted block design with a block size of 4. In this method: "A" represents a participant receiving the intervention (acupuncture). "B" represents a participant in the control group (pharmacotherapy). Implementation: All possible 4-sequence permutations (total of 6 combinations) will be used: ABAB BABA AABB BBAA ABBA BAAB Blocks of 4 will be randomly selected to ensure balanced group allocation. 2 Cervical spondylosis without myelopathy or radiculopathy. Intervention 1: Intervention group: Pharmacological Treatment Protocol: Piroxicam (NSAID):Dosage: 10 mg oral capsule Frequency: 1 capsule twice daily (BID)Duration: 10 days Methocarbamol (Muscle Relaxant):Dosage: 500 mg oral tablet Frequency: 3 tablets (1500 mg) three times daily (TID)Duration: 10 days. Intervention 2: Intervention group: Acupuncture Points for Cervical Spondylosis: Standard Points:SI-3 (Houxi)BL-10 (Tianzhu)BL-11 (Dazhu)BL-14 (Jueyinshu)BL-21 (Weishu)BL-60 (Kunlun)LI-4 (Hegu) – For lateral neck painLI-17 (Tianding) – For central/posterior painDU-14 (Dazhui)DU-20 (Baihui)SJ-5 (Waiguan)GB-20 (Fengchi)GB-21 (Jianjing)GB-34 (Yanglingquan)GB-39 (Xuanzhong)Clinical Rationale: Local Points (e.g., GB-20, BL-10): Target neck stiffness/pain directly. Distal Points (e.g., LI-4, GB-34): Enhance systemic analgesia and Qi flow.DU/GV Points (e.g., DU-14): Regulate Governor Vessel for spinal support. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Davoud Gholami
No. 366, Street 8, Nastran 2 Ave, Goldasht maali abad
Shiraz Iran (Islamic Republic of) 7188667917 +98 71 3639 1775 d_gholamid@sums.ac.ir Shiraz University of Medical Sciences scientific Davoud Gholami
No. 366, Street 8, Nastran 2 Ave, Goldasht maali abad
Shiraz Iran (Islamic Republic of) 7188667917 +98 71 3639 1775 d_gholamid@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Signs of Neck Pain and Stiffness Lasting More Than 6 Months 50 years 80 years Both Clinical signs of effusion, inflammation, redness Rheumatoid arthritis, Inflammatory arthropathy, Fibromyalgia Collagen vascular disease (Lupus), Gout, Cervical disc pathology Trauma, Fracture, Cervical spine surgery History of allergy and Allergic reaction to medications used (NSAIDs and Methocarbamol) M47.812 Cervical spondylosis without myelopathy or radiculopathy Treatment - Drugs Treatment - Devices Intervention group: Pharmacological Treatment Protocol: Piroxicam (NSAID):Dosage: 10 mg oral capsule Frequency: 1 capsule twice daily (BID)Duration: 10 days Methocarbamol (Muscle Relaxant):Dosage: 500 mg oral tablet Frequency: 3 tablets (1500 mg) three times daily (TID)Duration: 10 days Intervention group: Acupuncture Points for Cervical Spondylosis: Standard Points:SI-3 (Houxi)BL-10 (Tianzhu)BL-11 (Dazhu)BL-14 (Jueyinshu)BL-21 (Weishu)BL-60 (Kunlun)LI-4 (Hegu) – For lateral neck painLI-17 (Tianding) – For central/posterior painDU-14 (Dazhui)DU-20 (Baihui)SJ-5 (Waiguan)GB-20 (Fengchi)GB-21 (Jianjing)GB-34 (Yanglingquan)GB-39 (Xuanzhong)Clinical Rationale: Local Points (e.g., GB-20, BL-10): Target neck stiffness/pain directly. Distal Points (e.g., LI-4, GB-34): Enhance systemic analgesia and Qi flow.DU/GV Points (e.g., DU-14): Regulate Governor Vessel for spinal support. VAS (Visual Analog Scale) Assessment Protocol: Pain intensity will be evaluated using the Visual Analog Scale (VAS) at the following time points: Baseline (upon study entry)Post-intervention follow-ups: Week 2 Week 6 Week 12. Timepoint: Baseline (upon study entry)Post-intervention follow-ups: Week 2 Week 6 Week 12. Method of measurement: VAS (Visual Analog Scale) Assessment Protocol. NDI (Neck Disability Index) Assessment Protocol: The Neck Disability Index (NDI) questionnaire will be used to evaluate the severity of pain-related disability at the following intervals: Baseline (pre-intervention)Post-treatment follow-ups: Week 2Week 6Week 12. Timepoint: Baseline (pre-intervention)Post-treatment follow-ups: Week 2Week 6Week 12. Method of measurement: NDI (Neck Disability Index) Assessment Protocol. Cervical Spine Range of Motion (ROM) Assessment Protocol Measurement Method: Cervical ROM will be quantitatively evaluated using a goniometer at the following time points: Baseline (pre-intervention)Post-intervention follow-ups: Week 2Week 6Week 12. Timepoint: Baseline (pre-intervention)Post-intervention follow-ups: Week 2Week 6Week 12. Method of measurement: goniometer. Shiraz University of Medical Sciences Approved 2025-02-01 Ethics Committee of Shiraz University of Medical Sciences Ethics Committee, Office of Research Affairs 3rd Floor, Building No. 3 School of Medicine, Shiraz University of Medical Sciences Imam Hossein Square, Zand Street Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)