Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

Overview

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.

Full Title of Study: “Chiropractic Spinal Manipulative Therapy for Acute Neck Pain: a 4- Armed Clinical Placebo Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2023

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 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.

Interventions

  • Other: Chiropractic spinal manipulative therapy (CSMT)
    • See study arm.
  • Other: CSMT sham manipulation
    • See study arm.
  • Drug: Ibuprofen
    • See study arm.
  • Drug: Placebo medication
    • See study arm.

Arms, Groups and Cohorts

  • Experimental: Chiropractic Spinal Manipulative Therapy (CSMT)
    • A specific contact, high-velocity, low-amplitude, spinal thrust manipulation directed to spinal biomechanical dysfunction in the cervical and/or thoracic spinal column, as diagnosed by standard chiropractic tests, in accordance with their clinical judgment.
  • Sham Comparator: CSMT sham manipulation
    • A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line.
  • Active Comparator: Ibuprofen
    • Ibuprofen 600mg, 3 times daily for 12 days.
  • Sham Comparator: Placebo medication
    • Placebo medication, x 3 times daily for 12 days.

Clinical Trial Outcome Measures

Primary Measures

  • Mean pain intensity change
    • Time Frame: From baseline to day 14 after baseline between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Numerical Rating Scale (NRS) 0-10

Secondary Measures

  • Mean pain intensity change
    • Time Frame: From baseline to day 2, 3, 4, 5, 6, 7, 8 , 9, 10, 11, 12, 13 in the treatment period, and from baseline to day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Numerical Rating Scale (NRS) 0-10
  • Mean duration (hours) of neck pain change
    • Time Frame: From baseline to day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after baseline, day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Hours (0-24)
  • Mean number of days with neck pain per week
    • Time Frame: From the treatment period (14 days) to the periods; day 1-7, 22-28, 50-56, 78-84 and 162-168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Weekly number of days
  • Proportions of participants with mean daily pain intensity reduction of ≥50%, ≥75% and 100%
    • Time Frame: From baseline to day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 in the treatment period, and from baseline to day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, group 1 and group 4.
    • Numerical Rating Scale (NRS) 0-10
  • Proportions of participants with mean duration (hours) reduction of ≥50%, ≥75% and 100%
    • Time Frame: From baseline to day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 in the treatment period, and from baseline to day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, group 1 and group 4.
    • Hours 0-24
  • Proportions of participants with mean reduction of number of days with neck pain per week of ≥50%, ≥75% and 100%
    • Time Frame: From the 14 days treatment period, to the periods day 1-7, 22-28, 50-56, 78-84 and 162-168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Weekly number of days
  • Improvement in RAND-12 score (12 questions each with 5 possible answers)
    • Time Frame: From baseline to day 14 after baseline, day 84 and 168 posttreatment, respectively, comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • RAND-12 Term Short Form Health Survey (0 to 100, with higher scores indicating better physical and mental health functioning)
  • Improvement in Neck Disability Index score (10 questions each with 6 possible answers)
    • Time Frame: From baseline to day 14, and week 12- and 24 post-treatment.
    • Neck Disability Index (0-100, where 0 = no disability and 100 = complete disability)
  • Adverse event (AE) analysis
    • Time Frame: Daily during intervention period (day 1-13). AE analysis of group 1, group 2, group 3 and group 4, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4.
    • Within and between group adverse events analysis
  • Analysis of patients’ blinding (Manual therapy)
    • Time Frame: Daily during intervention period (day 1-13). Analysis of group 1 and 2 and comparison between group 1 and 2.
    • Numerical rating scale (NRS) 0-10 in relation to receiving real CSMT (0 absolutely unsure and 10 absolutely sure that real CSMT was received), irrespectively, whether the patient received sham or real CSMT
  • Analysis of patients’ blinding (Medicine)
    • Time Frame: Daily during intervention period (day 1-13). Analysis of group 1 and 2 and comparison between group 1 and 2.
    • Numerical rating scale (NRS) 0-10 in relation to receiving ibuprofen (0 absolutely unsure and 10 absolutely sure that ibuprofen was received), irrespectively, whether the patient received ibuprofen or placebo medicine
  • Patients’ and chiropractors’ expectations to treatment efficacy
    • Time Frame: Pre-treatment
    • Numerical rating scale (NRS) 0-10 (0 no expectation at all and 10 the highest possible expectation to treatment efficacy)
  • Analysis of patients’ satisfaction to treatment efficacy
    • Time Frame: Day 14 of the intervention period
    • Numerical rating scale (NRS) 0-10 (0 no satisfaction at all, and 10 the highest possible satisfaction)

Participating in This Clinical Trial

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 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 6 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 1. active peptic ulcer 2. gastrointestinal bleeding 3. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding 4. previous gastrointestinal bleeding or ulcer using NSAIDs 5. hypersensitivity to ibuprofen 6. asthma induced by acetylsalicylic acid or other NSAIDs 7. urticarial 8. rhinitis 9. severe heart failure (NYHA class IV) 10. renal failure (glomerulus infusion <30 ml/min) 2. Ingestion of NSAIDs 3. Prescription opioids within ≤14 days 4. Ingestion of any analgesics within ≤24 hours prior to baseline 5. On prescribed antidepressant 6. Major psychiatric disorder 7. Pregnancy or intention to be pregnant 8. Contraindication to SMT 9. Signs of spinal radiculopathy including progressive neurological deficit 10. Upper cervical spine instability (positive Sharp-Purser test) 11. Previous fracture in the cervical and/or thoracic spine 12. Previous cervical spine surgery 13. Recent (<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months 14. Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS) 15. Current chronic pain (defined as ≥3 months duration) 16. Rheumatoid arthritis 17. Recent (<2 weeks) acute respiratory infection with fever 18. Any presence of ischemic symptoms upon examination 19. Horner's syndrome 20. Medical history of arterial anomalies 21. History of connective tissue disorder 22. Familial history of cervical artery dissection 23. Other vascular disorders 24. Inability to understand instructions given in the Norwegian language 25. Inability to fill out digital questionnaires 26. Other reasons to exclude the patient as deemed necessary by the chiropractor

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Akershus
  • Collaborator
    • University of Oslo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael Bjorn Russell, Project leader and co-supervisor, Professor of neurology, consultant neurologist, PhD, DrMedSci – University Hospital, Akershus
  • Overall Official(s)
    • Michael B. Russell, Professor, Study Director, Division for Research and Innovation, Akershus University Hospital, Norway
    • Aleksander Chaibi, PhD, Principal Investigator, Institute for Health and Society, Faculty of Medicine, University of Oslo, Norway
  • Overall Contact(s)
    • Anna J. Allen-Unhammer, PhD student, +4792870783, a.j.allen-unhammer@medisin.uio.no

References

Chaibi A, Stavem K, Russell MB. Spinal Manipulative Therapy for Acute Neck Pain: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. J Clin Med. 2021 Oct 28;10(21). pii: 5011. doi: 10.3390/jcm10215011. Review.

Chaibi A, Šaltytė Benth J, Bjørn Russell M. Validation of Placebo in a Manual Therapy Randomized Controlled Trial. Sci Rep. 2015 Jul 6;5:11774. doi: 10.1038/srep11774.

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