Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

  • STATUS
    Recruiting
  • End date
    Aug 8, 2024
  • participants needed
    320
  • sponsor
    University Hospital, Akershus
Updated on 8 June 2022

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 the efficacy of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on acute neck pain is unknown. This 4-armed randomized controlled trial (RCT) will likely provide evidence for the efficacy of CSMT as well as NSAIDs. The applied methodology of the study will aim towards the highest research standards possible for manual-therapy RCTs, thus avoiding typical methodological shortcomings from previous manual-therapy studies. Our aim is to establish evidence-based knowledge on the efficacy of CSMT and NSAIDs in the treatment of acute neck pain.

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 manipulation, ibuprofen and placebo medication. NSAIDs are the most frequently prescribed medications by GPs worldwide and are widely used for patients with back pain. However, evidence-based data are missing for acute neck pain patients treated with NSAIDs while existing evidence for CSMT for acute neck pain are limited by serious methodological shortcomings.

The 4-armed placebo-controlled RCT will assess the efficacy in the following four treatment

groups
  1. Chiropractic spinal manipulative therapy (CSMT)
  2. CSMT sham manipulation (placebo)
  3. Ibuprofen (NSAID)
  4. Placebo medication

A total of ≥20 chiropractors from larger Norwegian cities will be recruited, distributed by gender and geography. The study participants presenting to each chiropractor will be block-randomized equally into one of four study groups based on a computer-generated algorithm. Each chiropractor will include 16 participants, four into each arm. A total of 320 participants will be enrolled in the RCT, within 12 months. Participants randomized into the chiropractic treatment groups will receive 5 interventions over 12 days, i.e., CSMT or CSMT sham manipulation; while the pharmacological groups will receive 600mg ibuprofen or placebo administered 3 times daily for 12 days.

Details
Condition Acute Neck Pain
Treatment ibuprofen, Placebo medication, Chiropractic spinal manipulative therapy (CSMT), CSMT sham manipulation
Clinical Study IdentifierNCT05374057
SponsorUniversity Hospital, Akershus
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

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 6 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)
Ingestion of NSAIDs
Prescription opioids within ≤14 days
Ingestion of any analgesics within ≤24 hours prior to baseline
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
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