Chiropractic Spinal Manipulative Therapy for Acute Neck Pain
Study Details
Study Description
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-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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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:
-
Chiropractic spinal manipulative therapy (CSMT)
-
CSMT sham manipulation (placebo)
-
Ibuprofen (NSAID)
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Chiropractic spinal manipulative therapy (CSMT)
See study arm.
|
| Sham Comparator: CSMT sham manipulation A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line. |
Other: CSMT sham manipulation
See study arm.
|
| Active Comparator: Ibuprofen Ibuprofen 600mg, 3 times daily for 12 days. |
Drug: Ibuprofen
See study arm.
Other Names:
|
| Sham Comparator: Placebo medication Placebo medication, x 3 times daily for 12 days. |
Drug: Placebo medication
See study arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean pain intensity change [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 Outcome Measures
- Mean pain intensity change [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 [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 [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% [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% [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% [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) [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) [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 [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) [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) [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 [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 [Day 14 of the intervention period]
Numerical rating scale (NRS) 0-10 (0 no satisfaction at all, and 10 the highest possible satisfaction)
Other Outcome Measures
- Sick leave [Mean number of days at baseline compared to week 12- and 24 post-treatment.]
Number of days and grade of sick leave
- Validation of user ID-number [All digital questionnaires from baseline to study completion, that is to 24-weeks follow-up.]
Number and proportions of incorrect typing of ID-numbers during digital questionnaire completion.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Michael B. Russell | Oslo | Norway | 1478 |
Sponsors and Collaborators
- University Hospital, Akershus
- University of Oslo
- The Dam Foundation
Investigators
- Study Director: Michael B. Russell, Professor, Division for Research and Innovation, Akershus University Hospital, Norway
- Principal Investigator: Aleksander Chaibi, PhD, Institute for Health and Society, Faculty of Medicine, University of Oslo, Norway
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 28498
- 2021-005483-21