Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

NCT ID: NCT05374057

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2024-08-31

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.

Conditions

Acute Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chiropractic spinal manipulative therapy (CSMT)

Intervention Type: OTHER

See study arm.

CSMT sham manipulation

A broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-therapeutic directional line.

Group Type: SHAM_COMPARATOR

CSMT sham manipulation

Intervention Type: OTHER

See study arm.

Ibuprofen

Ibuprofen 600mg, 3 times daily for 12 days.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

See study arm.

Placebo medication

Placebo medication, x 3 times daily for 12 days.

Group Type: SHAM_COMPARATOR

Placebo medication

Intervention Type: DRUG

See study arm.

Interventions

Chiropractic spinal manipulative therapy (CSMT)

See study arm.

Intervention Type: OTHER

CSMT sham manipulation

See study arm.

Intervention Type: OTHER

Ibuprofen

See study arm.

Intervention Type: DRUG

Placebo medication

See study arm.

Intervention Type: DRUG

Other Intervention Names

Orifarm; Placebo

Eligibility Criteria

Inclusion Criteria

1. Eligible participants are between the age of 18 and 59 years old

2. 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

3. Onset of the present episode ≤2 weeks prior to the 1st chiropractic visit

4. Moderate, severe or very severe pain intensity, i.e., ≥4, on a numeric rating scale (NRS) 0-10

5. Pain free for at least four consecutive weeks prior to the present pain episode

6. Not treated by a chiropractor during the past 3 months

7. Participants must accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period

8. Non-pregnant women. Women in doubt shall have a negative fertility test before inclusion

Exclusion Criteria

1. Contraindication to ibuprofen

1. active peptic ulcer

2. gastrointestinal bleeding

3. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding

4. previous gastrointestinal bleeding or ulcer using NSAIDs

5. hypersensitivity to ibuprofen

6. asthma induced by acetylsalicylic acid or other NSAIDs

7. urticarial

8. rhinitis

9. severe heart failure (NYHA class IV)

10. renal failure (glomerulus infusion <30 ml/min)

2. 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)

3. On prescribed antidepressant

4. Major psychiatric disorder

5. Pregnancy or intention to be pregnant

6. Contraindication to SMT

7. Signs of spinal radiculopathy including progressive neurological deficit

8. Upper cervical spine instability (positive Sharp-Purser test)

9. Previous fracture in the cervical and/or thoracic spine

10. Previous cervical spine surgery

11. Recent (<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months

12. Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS)

13. Current chronic pain (defined as ≥3 months duration)

14. Rheumatoid arthritis

15. Recent (<2 weeks) acute respiratory infection with fever

16. Any presence of ischemic symptoms upon examination

17. Horner's syndrome

18. Medical history of arterial anomalies

19. History of connective tissue disorder

20. Familial history of cervical artery dissection

21. Other vascular disorders

22. Inability to understand instructions given in the Norwegian language

23. Inability to fill out digital questionnaires

24. Other reasons to exclude the patient as deemed necessary by the chiropractor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

The Dam Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Michael Bjorn Russell

Project leader and co-supervisor, Professor of neurology, consultant neurologist, PhD, DrMedSci

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael B. Russell, Professor

Role: STUDY_DIRECTOR

Division for Research and Innovation, Akershus University Hospital, Norway

Aleksander Chaibi, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Michael B. Russell

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anna J. Allen-Unhammer, PhD student

Role: CONTACT

a.j.allen-unhammer@medisin.uio.no

+4792870783

Michael B. Russell, Professor

Role: CONTACT

m.b.russell@medisin.uio.no

+4540171553

Facility Contacts

Michael B. Russell, Professor

Role: primary

m.b.russell@medisin.uio.no

+4540171553

References

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.

Reference Type: BACKGROUND

PMID: 34768531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26145718 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38060549 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/34768531/

Background and rationale for the RCT

https://pubmed.ncbi.nlm.nih.gov/26145718/

CSMT Sham manipulation procedure

Other Identifiers

2021-005483-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

28498

Identifier Type: -

Identifier Source: org_study_id