Chiropractic Spinal Manipulative Therapy for Acute Neck Pain: a 4- Arm Clinical Placebo Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Chiropractic spinal manipulative therapy (CSMT)
- Conditions
- Acute Neck Pain
- Sponsor
- University Hospital, Akershus
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Mean pain intensity change
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 the efficacy of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on acute neck pain is unknown. This 4-arm 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.
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-arm 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 We intend to invite 40 recruiting chiropractors from larger Norwegian cities, 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.
Investigators
Michael Bjorn Russell
Project leader and co-supervisor, Professor of neurology, consultant neurologist, PhD, DrMedSci
University Hospital, Akershus
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Chiropractic spinal manipulative therapy (CSMT)
CSMT sham manipulation
A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line.
Intervention: CSMT sham manipulation
Ibuprofen
Ibuprofen 600mg, 3 times daily for 12 days.
Intervention: Ibuprofen
Placebo medication
Placebo medication, x 3 times daily for 12 days.
Intervention: Placebo medication
Outcomes
Primary Outcomes
Mean pain intensity change
Time Frame: From Day-0 to Day-14 between CSMT and sham CSMT, CSMT and ibuprofen, and CSMT and placebo medicine.
Numerical Rating Scale (NRS) 0-10
Secondary Outcomes
- Mean pain intensity change(From Day-0 to Day 2-13 in the treatment period, and from Day-0 to Day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Mean number of days with neck pain per week(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 CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Proportions of participants with mean daily pain intensity reduction of ≥50%, ≥75% and 100%(From Day-0 to Day 2-13 and 14, and from Day-0 to Day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Adverse event (AE) analysis(Daily during intervention period (day 2-13). AE analysis of CSMT, sham CSMT, ibuprofen, and placebo medicine, and comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Proportions of participants with mean reduction of number of days with neck pain per week of ≥50%, ≥75% and 100%(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 CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine)
- Mean duration (hours) of neck pain change(From Day-0 to Day 2-13 and 14; From Day-0 to Day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Improvement in Research and development 12 (RAND-12) score (12 questions each with 5 possible answers)(From Day-0 to Day-14, Day-84 and 168 post-treatment, respectively, comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Improvement in Neck Disability Index score (10 questions each with 6 possible answers)(From Day-0 to Day-14, Day-84 and 168 post-treatment, respectively, comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Proportions of participants with mean duration (hours) reduction of ≥50%, ≥75% and 100%(From Day-0 to Day 2-13 and 14, and from Day-0 to Day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between CSMT and sham CSMT, CSMT and ibuprofen, CSMT and placebo medicine, ibuprofen and placebo medicine.)
- Analysis of patients' blinding (Manual therapy)(Daily during intervention period (Day-0, Day 2-13). Analysis of CSMT and sham CSMT, and comparison between CSMT and sham CSMT.)
- Analysis of patients' blinding (Medicine)(Daily during intervention period (Day-0, Day 2-13). Analysis of ibuprofen and placebo medicine, and comparison between ibuprofen and placebo medicine.)
- Patients' and chiropractors' expectations to treatment efficacy(Day-0)
- Analysis of patients' satisfaction to treatment efficacy(Day-14 of the intervention period)