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Comparison of the effectiveness of acupuncture intervention with pharmacological treatment in improving neck pain and stiffness in patients with cervical spondylosis - clinical trial

Protocol summary

Study aim
Comparative Effectiveness of Oral Pharmacotherapy vs. Acupuncture Intervention in Patients with Cervical Spondylosis: Evaluation of Symptom Severity and Neck Range of Motion
Design
"A phase 3, randomized, open-label, parallel-group, controlled clinical trial conducted on 80 patients."
Settings and conduct
treatment Protocols: Group 1 (Pharmacological Therapy): Patients will receive: Oral piroxicam capsules (10 mg): 1 capsule twice daily (NSAID) Oral methocarbamol tablets (500 mg): 3 tablets (1500 mg) three times daily (muscle relaxant) Treatment duration: 10 days Group 2 (Acupuncture Therapy): Patients will undergo 10 acupuncture sessions over 2 weeks (5 sessions per week). Acupuncture points for cervical spondylosis: SI-3, BL-10, BL-11, BL-14, BL-21, BL-60, LI-4 (for lateral neck pain), LI-17 (for central/posterior pain), DU-14, DU-20, SJ-5, GB-20, GB-21, GB-34, GB-39. Adjunctive Therapies (Both Groups): All patients will be instructed in neck range-of-motion and strengthening exercises. Lifestyle modification education (activity adjustments, posture correction) will be provided. Outcome Assessments: Patients will be evaluated at: Baseline (study initiation) Post-intervention (2 weeks) Follow-ups: 6 weeks and 12 weeks after the last intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study: Patients with cervical spondylosis and osteoarthritis, aged 50 to 80 years, who have experienced neck pain and stiffness symptoms for more than 6 months, will be enrolled in the study after providing written informed consent.
Intervention groups
The first group will receive oral treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants for 10 days. The second group will undergo 10 sessions of acupuncture therapy over a period of two weeks for treatment.
Main outcome variables
VAS; NDI; Cervical ROM

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250514065735N1
Registration date: 2025-05-29, 1404/03/08
Registration timing: registered_while_recruiting

Last update: 2025-05-29, 1404/03/08
Update count: 0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Davoud Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3639 1775
Email address
d_gholamid@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-26, 1404/03/05
Expected recruitment end date
2025-07-27, 1404/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acupuncture intervention with pharmacological treatment in improving neck pain and stiffness in patients with cervical spondylosis - clinical trial
Public title
Comparison of the effectiveness of acupuncture intervention with pharmacological treatment in improving neck pain and stiffness in patients with cervical spondylosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signs of Neck Pain and Stiffness Lasting More Than 6 Months
Exclusion criteria:
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)
Age
From 50 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
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
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2025-02-01, 1403/11/13
Ethics committee reference number
IR.SUMS.MED.REC.1403.732

Health conditions studied

1

Description of health condition studied
Cervical spondylosis without myelopathy or radiculopathy
ICD-10 code
M47.812
ICD-10 code description
Cervical spondylosis without myelopathy or radiculopathy

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

1

Description
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

Intervention groups

1

Description
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
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emtyaz Hospital
Full name of responsible person
Davoud Gholami
Street address
First Alley, First Nayesh Street Nayesh Boulevard Abivardi District
City
shiraz
Province
Fars
Postal code
۷۱۹۴۸۱۵۷۱۱
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
7th Floor, Main Administration Building Shiraz University of Medical Sciences Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Davoud Gholami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 366, Street 8, Nastran 2 Ave, Goldasht maali abad
City
Shiraz
Province
Fars
Postal code
7188667917
Phone
+98 71 3639 1775
Fax
Email
d_gholamid@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Davoud Gholami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 366, Street 8, Nastran 2 Ave, Goldasht maali abad
City
Shiraz
Province
Fars
Postal code
7188667917
Phone
+98 71 3639 1775
Fax
Email
d_gholamid@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Davoud Gholami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 366, Street 8, Nastran 2 Ave, Goldasht maali abad
City
Shiraz
Province
Fars
Postal code
7188667917
Phone
+98 71 3639 1775
Fax
Email
d_gholamid@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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