Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

NCT05374057 | Unknown Phase 4 DMC

• 2 other identifiers: 284982021-005483-21
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Neck Pain

Keywords

Randomized controlled trial (RCT); Clinical trial; Acute neck pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Mean pain intensity change

  From Day-0 to Day-14. Comparison between ibuprofen and placebo medicine.

• 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 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.

• 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.

Other Outcomes (3)

• Sick leave

  Mean number of days at Day-0 compared to Week-12 and Week-24 post-treatment.

• Validation of user ID-number

  All digital questionnaires from Day-0 to study completion, that is to 24-weeks follow-up.

• Facilitatory/inhibitory factors/dilemmas affecting recruitment Qualitative focus group interviews to explore facilitatory/inhibitory factors and possible dilemmas experienced by chiropractor investigators.

  Up to 6 months

Study Arms (4)

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.

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.

Other: CSMT sham manipulation

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 600mg, 3 times daily for 12 days.

Drug: Ibuprofen

Placebo medication

SHAM COMPARATOR

Placebo medication, x 3 times daily for 12 days.

Drug: Placebo medication

Interventions

Chiropractic spinal manipulative therapy (CSMT) OTHER

See study arm.

Chiropractic Spinal Manipulative Therapy (CSMT)

CSMT sham manipulation OTHER

See study arm.

CSMT sham manipulation

Ibuprofen DRUG

See study arm.

Also known as: Orifarm

Ibuprofen

Placebo medication DRUG

See study arm.

Also known as: Placebo

Placebo medication

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• The Dam Foundation: collaborator

Study Sites (1)

Michael B. Russell

Oslo, 1478, Norway

RECRUITING

Related Publications (3)

• 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.

  PMID: 34768531 BACKGROUND

• Chaibi 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.

  PMID: 26145718 BACKGROUND

• Chaibi 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.

  PMID: 38060549 DERIVED

Related Links

• Background and rationale for the RCT
• CSMT Sham manipulation procedure

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Michael B. Russell, Professor

  Division for Research and Innovation, Akershus University Hospital, Norway

  STUDY DIRECTOR

• Aleksander Chaibi, PhD

  Institute for Health and Society, Faculty of Medicine, University of Oslo, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna J. Allen-Unhammer, PhD student

CONTACT

+4792870783; a.j.allen-unhammer@medisin.uio.no

Michael B. Russell, Professor

CONTACT

+4540171553; m.b.russell@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded. The two chiropractor groups are single-blinded, while the two pharmacological groups are double-blinded. Chiropractor investigators are un-blinded in relation to the manual therapy they apply. Outcome assessors are blinded to group allocation of participants during the study and data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader and co-supervisor, Professor of neurology, consultant neurologist, PhD, DrMedSci

Model Details: A 4-arm parallel clinical placebo randomized controlled Trial.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 13, 2022
• Study Start: May 23, 2022
• Primary Completion: December 31, 2023
• Study Completion: August 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)