Chiropractic spinal manipulative therapy for acute neck pain: a 4-armed clinical placebo randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Akershus University Hospital

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

8 Mar 2024 → ongoing

Decision date (initial)

2024-03-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Stiftelsen Dam · University of Oslo

External identifiers

EU CT number

2023-509624-17-00

EudraCT number

2021-005483-21

ClinicalTrials.gov

NCT05374057

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Investigate efficacy of CSMT and NSAIDs on the intensity of acute neck pain in the treatment period

Secondary objectives 1

1. Investigate efficacy of CSMT and NSAIDs on the intensity of acute neck pain in the follow-up period. Investigate efficacy of CSMT and NSAIDs on neck pain days and duration at different time points. Investigate efficacy of CSMT and NSAIDs on impact on health and effect on neck disability.

Conditions and MedDRA coding

Acute neck pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 (35). 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

1. 1. Contraindication to ibuprofen a. active peptic ulcer b. gastrointestinal bleeding c. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding d. previous gastrointestinal bleeding or ulcer using NSAIDs e. hypersensitivity to ibuprofen f. asthma induced by acetylsalicylic acid or other NSAIDs g. urticarial h. rhinitis i. severe heart failure (NYHA class IV) j. 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 questionnaire and are randomized at the clinic 3. On prescribed antidepressant. 4. Major psychiatric disorder. 5. Pregnancy or intension 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Group 1) CSMT 2) CSMT sham manipulation 3) Ibuprofen medication 4) Placebo medication. The primary end-point will be defined as the mean pain intensity on a NRS 0-10. The primary analysis will assess the difference in 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.

Secondary endpoints 1

1. Group 1) CSMT 2) CSMT sham manipulation 3) Ibuprofen medication 4) Placebo medication. 1. Mean pain intensity (NRS 0-10) 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, group 1 and group 4, and group 3 and 4. 2. Mean duration (hours) of neck pain change from baseline to day etc. See protocol for further details

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Akershus University Hospital

Sponsor organisation

Akershus University Hospital

Address

Sykehusveien 27

City

Lorenskog

Postcode

1478

Country

Norway

Scientific contact point

Organisation

Akershus University Hospital

Contact name

Michael Bjørn Russell

Public contact point

Organisation

Akershus University Hospital

Contact name

Michael Bjørn Russell

Locations

2 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications