Status:
UNKNOWN
Chiropractic Spinal Manipulative Therapy for Acute Neck Pain
Lead Sponsor:
University Hospital, Akershus
Collaborating Sponsors:
University of Oslo
The Dam Foundation
Conditions:
Acute Neck Pain
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
Acute neck is very common in the general population and often causes disability over shorter or longer time periods. Unfortunately, the efficacy of chiropractic spinal manipulative therapy (CSMT) and ...
Detailed Description
The Global Burden of Disease study ranks musculoskeletal neck pain as the most common disability worldwide. This study will highlight and validate CSMT for acute neck pain, compared to sham manipulati...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Eligible participants are between the age of 18 and 59 years old
- 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
- Onset of the present episode ≤2 weeks prior to the 1st chiropractic visit
- Moderate, severe or very severe pain intensity, i.e., ≥4, on a numeric rating scale (NRS) 0-10
- Pain free for at least four consecutive weeks prior to the present pain episode
- Not treated by a chiropractor during the past 3 months
- Participants must accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period
- Non-pregnant women. Women in doubt shall have a negative fertility test before inclusion
- Exclusion criteria
- Contraindication to ibuprofen
- active peptic ulcer
- gastrointestinal bleeding
- previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding
- previous gastrointestinal bleeding or ulcer using NSAIDs
- hypersensitivity to ibuprofen
- asthma induced by acetylsalicylic acid or other NSAIDs
- urticarial
- rhinitis
- severe heart failure (NYHA class IV)
- renal failure (glomerulus infusion \<30 ml/min)
- 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 questionnaires and are randomized at the clinic)
- On prescribed antidepressant
- Major psychiatric disorder
- Pregnancy or intention to be pregnant
- Contraindication to SMT
- Signs of spinal radiculopathy including progressive neurological deficit
- Upper cervical spine instability (positive Sharp-Purser test)
- Previous fracture in the cervical and/or thoracic spine
- Previous cervical spine surgery
- Recent (\<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months
- Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS)
- Current chronic pain (defined as ≥3 months duration)
- Rheumatoid arthritis
- Recent (\<2 weeks) acute respiratory infection with fever
- Any presence of ischemic symptoms upon examination
- Horner's syndrome
- Medical history of arterial anomalies
- History of connective tissue disorder
- Familial history of cervical artery dissection
- Other vascular disorders
- Inability to understand instructions given in the Norwegian language
- Inability to fill out digital questionnaires
- Other reasons to exclude the patient as deemed necessary by the chiropractor
Exclusion
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05374057
Start Date
May 23 2022
End Date
August 1 2024
Last Update
August 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Michael B. Russell
Oslo, Norway, 1478