Chiropractic spinal manipulative therapy for acute neck pain: a 4-armed clinical placebo randomized controlled trial

Akershus University Hospital0 sites320 target enrollmentFebruary 5, 2024

ConditionsAcute neck pain MedDRA version: 21.1Level: PTClassification code: 10028836Term: Neck pain Class: 100000004859 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute neck pain
Sponsor: Akershus University Hospital
Enrollment: 320
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 5, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Akershus University Hospital

Eligibility Criteria

Inclusion Criteria

•1\. Eligible participants are between the age of 18 and 59 years old 2\. Acute non\-radicular neck pain, i.e., grade 1 or 2 according to the classification by the Bone and Joint Decade 2000\-2010 Task Force on neck pain (35\). 3\. Onset of the present episode \=2 weeks prior to the 1st chiropractic visit. 4\. Moderate, severe or very severe pain intensity, i.e., \=4, on a numeric rating scale (NRS) 0\-10\. 5\. Pain free for at least four consecutive weeks prior to the present pain episode. 6\. Not treated by a chiropractor during the past 3 months. 7\. Participants must accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period. 8\. Non\-pregnant women. Women in doubt shall have a negative fertility test before inclusion.

Exclusion Criteria

•1\. Contraindication to ibuprofen a. active peptic ulcer b. gastrointestinal bleeding c. previous repeated episode (\=2 detected events) with peptic ulcer or gastrointestinal bleeding d. previous gastrointestinal bleeding or ulcer using NSAIDs e. hypersensitivity to ibuprofen f. asthma induced by acetylsalicylic acid or other NSAIDs g. urticarial h. rhinitis i. severe heart failure (NYHA class IV) j. renal failure (glomerulus infusion \<30 ml/min), 2\. Taken pain\- and/or anti\-inflammatory medicine during the past 24 hours? Patients that have taken acute pain\- and/or anti\-inflammatory medicine including ibuprofen can be included if they come back after 24 hours without having taken the medicine where they then fill out questionnaire and are randomized at the clinic 3\. On prescribed antidepressant. 4\. Major psychiatric disorder. 5\. Pregnancy or intension to be pregnant 6\. Contraindication to SMT. 7\. Signs of spinal radiculopathy including progressive neurological deficit 8\. Upper cervical spine instability (positive Sharp\-Purser test) 9\. Previous fracture in the cervical and/or thoracic spine 10\. Previous cervical spine surgery, 11\. Recent (\<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months 12\. Concomitant low back pain with moderate, severe or very severe pain intensity (\=4 on a NRS) 13\. Current chronic pain (defined as \=3 months duration) 14\. Rheumatoid arthritis 15\. Recent (\<2 weeks) acute respiratory infection with fever 16\. Any presence of ischemic symptoms upon examination 17\. Horner’s syndrome 18\. Medical history of arterial anomalies 19\. History of connective tissue disorder 20\. Familial history of cervical artery dissection 21\. Other vascular disorders 22\. Inability to understand instructions given in the Norwegian language 23\. Inability to fill out digital questionnaires 24\. Other reasons to exclude the patient as deemed necessary by the chiropractor.