Acute Neck PainPhase 4NCT05374057
Chiropractic Spinal Manipulative Therapy for Acute Neck Pain
A Phase 4 study testing Chiropractic spinal manipulative therapy (CSMT) and Ibuprofen in people with Acute Neck Pain, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Acute Neck Pain
- What is being tested?
- Chiropractic spinal manipulative therapy (CSMT) and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteNorway
- Study dates
- 23 May 2022to Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Michael B. Russell
Oslo, 1478
Michael B. Russell, Professor, +4540171553, m.b.russell@medisin.uio.no
Aleksander Chaibi, PhD
About this study
Official title: Chiropractic Spinal Manipulative Therapy for Acute Neck Pain: a 4- Arm Clinical Placebo Randomized Controlled Trial
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.
Read the 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:
- 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.
- Conditions
- Acute Neck Pain
- Being tested
- Chiropractic spinal manipulative therapy (CSMT), CSMT sham manipulation, Ibuprofen, Placebo medication
- Keywords
- Randomized controlled trial (RCT), Clinical trial, Acute neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic spinal manipulative therapy (CSMT)Other
See study arm.
CSMT sham manipulationOther
See study arm.
IbuprofenDrug
Also called Orifarm
See study arm.
Placebo medicationDrug
Also called Placebo
See study arm.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic Spinal Manipulative Therapy (CSMT) | Experimental | 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. Receives: Other: Chiropractic spinal manipulative therapy (CSMT) |
| CSMT sham manipulation | Sham comparator | A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line. Receives: Other: CSMT sham manipulation |
| Ibuprofen | Active comparator | Ibuprofen 600mg, 3 times daily for 12 days. Receives: Drug: Ibuprofen |
| Placebo medication | Sham comparator | Placebo medication, x 3 times daily for 12 days. Receives: Drug: Placebo medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity change
Numerical Rating Scale (NRS) 0-10
Measured: From Day-0 to Day-14 between CSMT and sham CSMT, CSMT and ibuprofen, and CSMT and placebo medicine.
Secondary outcomes (14)
Mean pain intensity change
Numerical Rating Scale (NRS) 0-10
Measured: From Day-0 to Day-14. Comparison between ibuprofen and placebo medicine.
Mean pain intensity change
Numerical Rating Scale (NRS) 0-10
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Day-14 of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start23 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 4-arm parallel clinical placebo randomized controlled Trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, The Dam Foundation
- Responsible party
- Principal investigator, Michael Bjorn Russell, University Hospital, Akershus
- Investigators
- Michael B. Russell, Professor, Study director, Division for Research and Innovation, Akershus University Hospital, NorwayAleksander Chaibi, PhD, Principal investigator, Institute for Health and Society, Faculty of Medicine, University of Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374057
- Sponsor's protocol ID
- 28498
- Other IDs
- 2021-005483-21
- Status last verified
- Mar 2023
- First submitted
- 5 May 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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):5011. doi: 10.3390/jcm10215011.
PubMed 34768531Chaibi A, Saltyte Benth J, Bjorn Russell M. Validation of Placebo in a Manual Therapy Randomized Controlled Trial. Sci Rep. 2015 Jul 6;5:11774. doi: 10.1038/srep11774.
PubMed 26145718Chaibi A, Allen-Unhammer A, Kopke Vollestad N, Russell MB. Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol. PLoS One. 2023 Dec 7;18(12):e0295115. doi: 10.1371/journal.pone.0295115. eCollection 2023.
PubMed 38060549
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Spinal Manipulative Therapy for Acute Neck Pain: a 4- Arm Clinical Placebo Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05374057
- Acronym / sponsor ID
- 28498
- Conditions
- Acute Neck Pain
- Keywords
- Randomized controlled trial (RCT), Clinical trial, Acute neck pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, The Dam Foundation
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A 4-arm parallel clinical placebo randomized controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Spinal Manipulative Therapy (CSMT) | Experimental | Other: 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. |
| CSMT sham manipulation | Sham comparator | Other: CSMT sham manipulationA broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line. |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 600mg, 3 times daily for 12 days. |
| Placebo medication | Sham comparator | Drug: Placebo medicationPlacebo medication, x 3 times daily for 12 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (34 listed)
- Contraindication to ibuprofen
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic spinal manipulative therapy (CSMT)See study arm. | Other | Chiropractic Spinal Manipulative Therapy (CSMT) |
| CSMT sham manipulationSee study arm. | Other | CSMT sham manipulation |
| IbuprofenAlso: OrifarmSee study arm. | Drug | Ibuprofen |
| Placebo medicationAlso: PlaceboSee study arm. | Drug | Placebo medication |
Primary outcome
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
14 secondary outcomes
Mean pain intensity change
Time frame: From Day-0 to Day-14. Comparison between ibuprofen and placebo medicine.
Mean pain intensity change
Time frame: 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
Time frame: 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
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 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%
Time frame: 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%
Time frame: 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%
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 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Day-0
Analysis of patients' satisfaction to treatment efficacy
Time frame: Day-14 of the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 34768531Chaibi 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):5011. doi: 10.3390/jcm10215011.
- Background: PubMed 26145718Chaibi A, Saltyte Benth J, Bjorn Russell M. Validation of Placebo in a Manual Therapy Randomized Controlled Trial. Sci Rep. 2015 Jul 6;5:11774. doi: 10.1038/srep11774.
- Derived from this study: PubMed 38060549Chaibi A, Allen-Unhammer A, Kopke Vollestad N, Russell MB. Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol. PLoS One. 2023 Dec 7;18(12):e0295115. doi: 10.1371/journal.pone.0295115. eCollection 2023.
- Background and rationale for the RCTLink provided by the sponsor.
- CSMT Sham manipulation procedureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chiropractic spinal manipulative therapy (CSMT) and Ibuprofen in people with Acute Neck Pain, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna J. Allen-Unhammer, PhD student (+4792870783, a.j.allen-unhammer@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.