Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

Study Overview
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Brief Summary
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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
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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: Chiropractic spinal manipulative therapy (CSMT) CSMT sham manipulation (placebo) Ibuprofen (NSAID) 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.

Official Title
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Chiropractic Spinal Manipulative Therapy for Acute Neck Pain: a 4- Arm Clinical Placebo Randomized Controlled Trial

Conditions
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Acute Neck Pain

Intervention / Treatment
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* Other: Chiropractic spinal manipulative therapy (CSMT)
* Other: CSMT sham manipulation
* Drug: Ibuprofen
* Drug: Placebo medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 4-arm parallel clinical placebo randomized controlled Trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic Spinal Manipulative Therapy (CSMT)<br>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. | Other: Chiropractic spinal manipulative therapy (CSMT)<br>* See study arm.<br>|
| Sham Comparator: CSMT sham manipulation<br>A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line. | Other: CSMT sham manipulation<br>* See study arm.<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 600mg, 3 times daily for 12 days. | Drug: Ibuprofen<br>* See study arm.<br>* Other names: Orifarm;|
| Sham Comparator: Placebo medication<br>Placebo medication, x 3 times daily for 12 days. | Drug: Placebo medication<br>* See study arm.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain intensity change | Numerical Rating Scale (NRS) 0-10 | From Day-0 to Day-14 between CSMT and sham CSMT, CSMT and ibuprofen, and CSMT and placebo medicine. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain intensity change | Numerical Rating Scale (NRS) 0-10 | From Day-0 to Day-14. Comparison between ibuprofen and placebo medicine. | 
| Mean pain intensity change | Numerical Rating Scale (NRS) 0-10 | 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 duration (hours) of neck pain change | Hours (0-24) | 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. | 
| Mean number of days with neck pain per week | Weekly number of days | 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% | Numerical Rating Scale (NRS) 0-10 | 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. | 
| Proportions of participants with mean duration (hours) reduction of ≥50%, ≥75% and 100% | Hours 0-24 | 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. | 
| Proportions of participants with mean reduction of number of days with neck pain per week of ≥50%, ≥75% and 100% | Weekly number of days | 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 | 
| Improvement in Research and development 12 (RAND-12) score (12 questions each with 5 possible answers) | RAND-12 Term Short Form Health Survey (0 to 100, with higher scores indicating better physical and mental health functioning) | 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) | Neck Disability Index (0-100, where 0 = no disability and 100 = complete disability) | 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. | 
| Adverse event (AE) analysis | Within and between group adverse events 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. | 
| Analysis of patients' blinding (Manual therapy) | Numerical rating scale (NRS) 0-10 in relation to receiving real CSMT (0 absolutely unsure and 10 absolutely sure that real CSMT was received), irrespective of whether the patient received sham or real CSMT | 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) | Numerical rating scale (NRS) 0-10 in relation to receiving ibuprofen (0 absolutely unsure and 10 absolutely sure that ibuprofen was received), irrespective of whether the patient received ibuprofen or placebo 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 | Numerical rating scale (NRS) 0-10 (0 no expectation at all and 10 the highest possible expectation to treatment efficacy) | Day-0 | 
| Analysis of patients' satisfaction to treatment efficacy | Numerical rating scale (NRS) 0-10 (0 no satisfaction at all, and 10 the highest possible satisfaction) | Day-14 of the intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial (RCT), Clinical trial, Acute neck pain